Pain, Postoperative
Conditions
Keywords
Flare up
Brief summary
This study evaluates the role of propolis paste as compared to calcium hydroxide (when used as intracanal medication) in prevention and treatment of pain after root canal treatment in necrotic (infected) teeth. Half of the participants will receive calcium hydroxide, while the other half will receive propolis.
Detailed description
Propolis is a developing herbal medicament used in various aspects on dentistry. it is extremely biocompatible; has flavanoids; which acts as anti-inflammatory and antimicrobial components. Calcium hydroxide is a synthetic medication which is antibacterial
Interventions
DRUGPropolis
it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days.
DRUGCalcium Hydroxide
it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days.
Sponsors
Dow University of Health Sciences
Juzer Shabbir Saifee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Single rooted Necrotic teeth with symptomatic or asymptomatic periapical periodontitis having periapical widening or radiolucency without bone expansion (PAI index 2, 3 and 4). * Teeth with favorable root morphology. * Teeth with closed apex.
Exclusion criteria
* Teeth with PAI index 1 and 5. * Patients who are on antibiotics. * Patient with recent trauma to the jaw. * Teeth with open apex * Multi-rooted teeth. * Vital teeth. * Non-restorable teeth. * Unfavorable root morphology (severely curved, dilacerated, severely sclerosed or obliterated). * Teeth associated with soft tissue abscess or swelling. * Teeth with external or internal root resorption * Re-treatment cases. * Periodontally compromised teeth (like mobile teeth and teeth with excessive bone loss). * Teeth requiring endodontic surgery. * Teeth requiring non-surgical endodontic treatment of multiple teeth in the same or opposing quadrant. * Medically compromised patients (ASA-III and above), patients with special communication needs or who doesn't understand Urdu or English language. * Patients allergic to bee pollen or honey products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Measure: Visual Analogue Pain Scale | 4 hours, 12 hours, day 2, day 3 and day 4 | Self recorded pain intensity by the patients at 4 hours, 12 hours, day 2, day 3 and day 4 after root canal preparation and intracanal medicament insertion (first visit). Pain intensity recorded on a Visual Analogue Scale from 0 to 100. Patients who experience no or mild pain; and do not require analgesic will record their pain intensity from 0 to 24. Patients who experience moderate pain; and require Over-the-counter analgesic will record pain intensity from 25 to 49. Patients who experience severe pain; and require use of codeine containing medicine will record their pain intensity from 50 to 74. Patients who experience extreme pain, and no medicine is able to relieve their pain will record pain intensity from 75 to 100. lower pain score (intensity) is a better outcome as compared to higher pain intensity (score) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Increase in Pain Score (Acute Exacerbation of Pain) | 4 hours, 12 hours, day 2, day 3, and day 4 | An increase of 20 or more points on Visual Analogue Pain Scale from pain score of previous time interval Information about the Visual Analogue Scale: * it consists of pain score from 0 to 100. * The higher the pain score; the worse the pain * An increase of a total of at least 20 pain score points from previous pain score reading indicate that pain has increased significantly and will be reported as flare-up |
| Difference of Pain Score Between Different Time Intervals | 4 hours, 12 hours, day 2, day 3, and day 4 | Visual Analogue Pain Score information: * pain intensity is measured with this scale * minimum pain score reading on Visual Analogue Scale is 0 and Maximum is 100 * higher values represent worse pain and lower values represent lesser pain this pain score is recorded pre-operatively, then at time intervals of 4 hours, 12 hours, day 2, day 3 and day 4. the comparison of mean pain scores of different time intervals will be made. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Difference of Pain Scores Between Males and Females | 4 hours, 12 hours, day 2, day 3, and day 4 | Information about Visual Analogue Scale for rating pain scores: * minimum pain score on this scale is 0 and maximum is 100 * more the pain score; worse the pain * mean pain score difference between males and females at different time intervals was assessed * scale is divided into 4 segments: 0 to 24 (no or mild pain), 25 to 49 (moderate pain), 50 to 74 (severe pain); 75 to 100 (extreme pain). |
| Difference of Pain Scores Between Different Age Groups | 4 hours, 12 hours, day 2, day 3, and day 4 | Information about Visual Analogue Scale for rating pain scores: * minimum pain score on this scale is 0 and maximum is 100 * more the pain score; worse the pain * mean pain score difference between different age groups: 20 to 24; 25 to 29; 30 to 34; and 35 to 40 at different time intervals was assessed * scale is divided into 4 segments: 0 to 24 (no or mild pain), 25 to 49 (moderate pain), 50 to 74 (severe pain); 75 to 100 (extreme pain). |
Countries
Pakistan
Participant flow
Recruitment details
Start of recruitment : 1st october 2017 End of Recruitment: 24th april 2018 location: Pakistan; Karachi; Dow-International dental college, Operative Dentistry; out-patient department.
Participants by arm
| Arm | Count |
|---|---|
| Control Group or Group I or Calcium Hydroxide Group Calcium Hydroxide: it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days. | 40 |
| Experimental Group or Group II or Propolis Group Propolis: it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Control Group or Group I or Calcium Hydroxide Group | Experimental Group or Group II or Propolis Group | Total |
|---|---|---|---|
| Age, Continuous | 33.6 years STANDARD_DEVIATION 6.3 | 33.2 years STANDARD_DEVIATION 6 | 33.4 years STANDARD_DEVIATION 6.1 |
| Age, Customized Age Range 20 to 24 | 4 Participants | 4 Participants | 8 Participants |
| Age, Customized Age Range 25 to 29 | 7 Participants | 4 Participants | 11 Participants |
| Age, Customized Age Range 30 to 34 | 6 Participants | 13 Participants | 19 Participants |
| Age, Customized Age Range 35 to 40 | 23 Participants | 19 Participants | 42 Participants |
| Pre-operative pain score from 0 (no pain) to 100 (worst pain) on Visual Analogue Scale | 13.1 units on a scale STANDARD_DEVIATION 17.4 | 18.1 units on a scale STANDARD_DEVIATION 12.4 | 15.6 units on a scale STANDARD_DEVIATION 17.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 40 Participants | 40 Participants | 80 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Pakistan | 40 Number of participants | 40 Number of participants | 80 Number of participants |
| Sex: Female, Male Female | 28 Participants | 22 Participants | 50 Participants |
| Sex: Female, Male Male | 12 Participants | 18 Participants | 30 Participants |
| Type of single-rooted teeth Mandibular Canine | 1 Number of teeth | 2 Number of teeth | 3 Number of teeth |
| Type of single-rooted teeth Mandibular First Premolar | 4 Number of teeth | 5 Number of teeth | 9 Number of teeth |
| Type of single-rooted teeth Mandibular Lateral Incisor | 3 Number of teeth | 0 Number of teeth | 3 Number of teeth |
| Type of single-rooted teeth Mandibular Second Premolar | 10 Number of teeth | 6 Number of teeth | 16 Number of teeth |
| Type of single-rooted teeth Maxillary Canine | 8 Number of teeth | 7 Number of teeth | 15 Number of teeth |
| Type of single-rooted teeth Maxillary Central Incisor | 4 Number of teeth | 2 Number of teeth | 6 Number of teeth |
| Type of single-rooted teeth Maxillary Lateral Incisor | 4 Number of teeth | 4 Number of teeth | 8 Number of teeth |
| Type of single-rooted teeth Maxillary Second Premolar | 6 Number of teeth | 14 Number of teeth | 20 Number of teeth |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 4 / 40 | 6 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Pain Intensity Measure: Visual Analogue Pain Scale
Self recorded pain intensity by the patients at 4 hours, 12 hours, day 2, day 3 and day 4 after root canal preparation and intracanal medicament insertion (first visit). Pain intensity recorded on a Visual Analogue Scale from 0 to 100. Patients who experience no or mild pain; and do not require analgesic will record their pain intensity from 0 to 24. Patients who experience moderate pain; and require Over-the-counter analgesic will record pain intensity from 25 to 49. Patients who experience severe pain; and require use of codeine containing medicine will record their pain intensity from 50 to 74. Patients who experience extreme pain, and no medicine is able to relieve their pain will record pain intensity from 75 to 100. lower pain score (intensity) is a better outcome as compared to higher pain intensity (score)
Time frame: 4 hours, 12 hours, day 2, day 3 and day 4
Population: Out of 80 patients, 12 did not return for follow-up; and no contact could be established with them. Out of these 12 patients, 7 belong to control group and 5 belong to experimental group. Hence, 33 patients in control group and 35 patients in experimental group could be analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group or Group I or Calcium Hydroxide Group | Pain Intensity Measure: Visual Analogue Pain Scale | 4 hours | 11.8 score on a scale | Standard Deviation 18.7 |
| Control Group or Group I or Calcium Hydroxide Group | Pain Intensity Measure: Visual Analogue Pain Scale | Day 3 | 2.6 score on a scale | Standard Deviation 6.4 |
| Control Group or Group I or Calcium Hydroxide Group | Pain Intensity Measure: Visual Analogue Pain Scale | Day 2 | 3.5 score on a scale | Standard Deviation 7.7 |
| Control Group or Group I or Calcium Hydroxide Group | Pain Intensity Measure: Visual Analogue Pain Scale | Day 4 | 1.9 score on a scale | Standard Deviation 4.7 |
| Control Group or Group I or Calcium Hydroxide Group | Pain Intensity Measure: Visual Analogue Pain Scale | 12 hours | 9.4 score on a scale | Standard Deviation 16.7 |
| Experimental Group or Group II or Propolis Group | Pain Intensity Measure: Visual Analogue Pain Scale | Day 4 | 2.7 score on a scale | Standard Deviation 7.3 |
| Experimental Group or Group II or Propolis Group | Pain Intensity Measure: Visual Analogue Pain Scale | 4 hours | 8.8 score on a scale | Standard Deviation 11.1 |
| Experimental Group or Group II or Propolis Group | Pain Intensity Measure: Visual Analogue Pain Scale | Day 2 | 5.1 score on a scale | Standard Deviation 9.2 |
| Experimental Group or Group II or Propolis Group | Pain Intensity Measure: Visual Analogue Pain Scale | Day 3 | 3.4 score on a scale | Standard Deviation 6.8 |
| Experimental Group or Group II or Propolis Group | Pain Intensity Measure: Visual Analogue Pain Scale | 12 hours | 10.3 score on a scale | Standard Deviation 13.3 |
p-value: 0.329ANOVA
p-value: 0.764ANOVA
p-value: 0.605ANOVA
p-value: 0.786ANOVA
p-value: 0.813ANOVA
Secondary
Acute Increase in Pain Score (Acute Exacerbation of Pain)
An increase of 20 or more points on Visual Analogue Pain Scale from pain score of previous time interval Information about the Visual Analogue Scale: * it consists of pain score from 0 to 100. * The higher the pain score; the worse the pain * An increase of a total of at least 20 pain score points from previous pain score reading indicate that pain has increased significantly and will be reported as flare-up
Time frame: 4 hours, 12 hours, day 2, day 3, and day 4
Population: Out of 80 patients, 12 did not return for follow-up; and no contact could be established with them. Out of these 12 patients, 7 belong to control group and 5 belong to experimental group. Hence, 33 patients in control group and 35 patients in experimental group could be analyzed
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control Group or Group I or Calcium Hydroxide Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | 4 hours | No flare up | 29 Participants |
| Control Group or Group I or Calcium Hydroxide Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | Day 3 | Flare up | 0 Participants |
| Control Group or Group I or Calcium Hydroxide Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | 12 hours | No flare up | 33 Participants |
| Control Group or Group I or Calcium Hydroxide Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | Day 3 | No flare up | 33 Participants |
| Control Group or Group I or Calcium Hydroxide Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | Day 4 | Flare up | 0 Participants |
| Control Group or Group I or Calcium Hydroxide Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | 4 hours | Flare up | 4 Participants |
| Control Group or Group I or Calcium Hydroxide Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | Day 4 | No flare up | 33 Participants |
| Control Group or Group I or Calcium Hydroxide Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | Day 2 | Flare up | 0 Participants |
| Control Group or Group I or Calcium Hydroxide Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | Total | Flare up | 4 Participants |
| Control Group or Group I or Calcium Hydroxide Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | 12 hours | Flare up | 0 Participants |
| Control Group or Group I or Calcium Hydroxide Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | Total | No flare up | 29 Participants |
| Control Group or Group I or Calcium Hydroxide Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | Day 2 | No flare up | 33 Participants |
| Experimental Group or Group II or Propolis Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | Total | No flare up | 29 Participants |
| Experimental Group or Group II or Propolis Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | 4 hours | Flare up | 1 Participants |
| Experimental Group or Group II or Propolis Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | 4 hours | No flare up | 34 Participants |
| Experimental Group or Group II or Propolis Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | 12 hours | Flare up | 4 Participants |
| Experimental Group or Group II or Propolis Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | 12 hours | No flare up | 31 Participants |
| Experimental Group or Group II or Propolis Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | Day 2 | Flare up | 1 Participants |
| Experimental Group or Group II or Propolis Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | Day 2 | No flare up | 34 Participants |
| Experimental Group or Group II or Propolis Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | Day 3 | Flare up | 0 Participants |
| Experimental Group or Group II or Propolis Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | Day 4 | Flare up | 0 Participants |
| Experimental Group or Group II or Propolis Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | Day 4 | No flare up | 35 Participants |
| Experimental Group or Group II or Propolis Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | Total | Flare up | 6 Participants |
| Experimental Group or Group II or Propolis Group | Acute Increase in Pain Score (Acute Exacerbation of Pain) | Day 3 | No flare up | 35 Participants |
Secondary
Difference of Pain Score Between Different Time Intervals
Visual Analogue Pain Score information: * pain intensity is measured with this scale * minimum pain score reading on Visual Analogue Scale is 0 and Maximum is 100 * higher values represent worse pain and lower values represent lesser pain this pain score is recorded pre-operatively, then at time intervals of 4 hours, 12 hours, day 2, day 3 and day 4. the comparison of mean pain scores of different time intervals will be made.
Time frame: 4 hours, 12 hours, day 2, day 3, and day 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group or Group I or Calcium Hydroxide Group | Difference of Pain Score Between Different Time Intervals | Pain score difference; 4 hours - 12 hours | 2.33 score on a scale | Standard Error 3 |
| Control Group or Group I or Calcium Hydroxide Group | Difference of Pain Score Between Different Time Intervals | Pain score difference; day 2 - day 3 | 0.94 score on a scale | Standard Error 3 |
| Control Group or Group I or Calcium Hydroxide Group | Difference of Pain Score Between Different Time Intervals | Pain score difference; 12 hours - day 2 | 5.88 score on a scale | Standard Error 3 |
| Control Group or Group I or Calcium Hydroxide Group | Difference of Pain Score Between Different Time Intervals | Pain score difference; day 3 - day 4 | 0.67 score on a scale | Standard Error 3 |
| Control Group or Group I or Calcium Hydroxide Group | Difference of Pain Score Between Different Time Intervals | Pain score difference; pre-operative - 4 hours | 2.97 score on a scale | Standard Error 3 |
| Experimental Group or Group II or Propolis Group | Difference of Pain Score Between Different Time Intervals | Pain score difference; day 3 - day 4 | 0.77 score on a scale | Standard Error 2.9 |
| Experimental Group or Group II or Propolis Group | Difference of Pain Score Between Different Time Intervals | Pain score difference; pre-operative - 4 hours | 11.80 score on a scale | Standard Error 2.9 |
| Experimental Group or Group II or Propolis Group | Difference of Pain Score Between Different Time Intervals | Pain score difference; 4 hours - 12 hours | -1.54 score on a scale | Standard Error 2.9 |
| Experimental Group or Group II or Propolis Group | Difference of Pain Score Between Different Time Intervals | Pain score difference; 12 hours - day 2 | 5.23 score on a scale | Standard Error 2.9 |
| Experimental Group or Group II or Propolis Group | Difference of Pain Score Between Different Time Intervals | Pain score difference; day 2 - day 3 | 1.69 score on a scale | Standard Error 2.9 |
p-value: 0.334ANOVA
p-value: 0.448ANOVA
p-value: 0.056ANOVA
p-value: 0.76ANOVA
p-value: 0.828ANOVA
p-value: 0ANOVA
p-value: 0.605ANOVA
p-value: 0.8ANOVA
p-value: 0.574ANOVA
p-value: 0.796ANOVA
Other Pre-specified
Difference of Pain Scores Between Different Age Groups
Information about Visual Analogue Scale for rating pain scores: * minimum pain score on this scale is 0 and maximum is 100 * more the pain score; worse the pain * mean pain score difference between different age groups: 20 to 24; 25 to 29; 30 to 34; and 35 to 40 at different time intervals was assessed * scale is divided into 4 segments: 0 to 24 (no or mild pain), 25 to 49 (moderate pain), 50 to 74 (severe pain); 75 to 100 (extreme pain).
Time frame: 4 hours, 12 hours, day 2, day 3, and day 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group or Group I or Calcium Hydroxide Group | Difference of Pain Scores Between Different Age Groups | Mean pain score; day 3 | 1.5 score on a scale | Standard Deviation 3.6 |
| Control Group or Group I or Calcium Hydroxide Group | Difference of Pain Scores Between Different Age Groups | Mean pain score; 12 hours | 8.3 score on a scale | Standard Deviation 14.3 |
| Control Group or Group I or Calcium Hydroxide Group | Difference of Pain Scores Between Different Age Groups | Mean pain score; 4 hours | 7.1 score on a scale | Standard Deviation 9.1 |
| Control Group or Group I or Calcium Hydroxide Group | Difference of Pain Scores Between Different Age Groups | Mean pain score; day 2 | 0 score on a scale | Standard Deviation 0 |
| Control Group or Group I or Calcium Hydroxide Group | Difference of Pain Scores Between Different Age Groups | Mean pain score; day 4 | 0 score on a scale | Standard Deviation 0 |
| Experimental Group or Group II or Propolis Group | Difference of Pain Scores Between Different Age Groups | Mean pain score; day 4 | 2.1 score on a scale | Standard Deviation 6.2 |
| Experimental Group or Group II or Propolis Group | Difference of Pain Scores Between Different Age Groups | Mean pain score; day 3 | 4 score on a scale | Standard Deviation 9.6 |
| Experimental Group or Group II or Propolis Group | Difference of Pain Scores Between Different Age Groups | Mean pain score; 4 hours | 14.5 score on a scale | Standard Deviation 15.1 |
| Experimental Group or Group II or Propolis Group | Difference of Pain Scores Between Different Age Groups | Mean pain score; 12 hours | 12.9 score on a scale | Standard Deviation 17.9 |
| Experimental Group or Group II or Propolis Group | Difference of Pain Scores Between Different Age Groups | Mean pain score; day 2 | 10.6 score on a scale | Standard Deviation 13.1 |
| Age Group; 30 to 34 | Difference of Pain Scores Between Different Age Groups | Mean pain score; 12 hours | 13.6 score on a scale | Standard Deviation 16.3 |
| Age Group; 30 to 34 | Difference of Pain Scores Between Different Age Groups | Mean pain score; day 2 | 3.7 score on a scale | Standard Deviation 6.9 |
| Age Group; 30 to 34 | Difference of Pain Scores Between Different Age Groups | Mean pain score; day 3 | 1.5 score on a scale | Standard Deviation 4.2 |
| Age Group; 30 to 34 | Difference of Pain Scores Between Different Age Groups | Mean pain score; 4 hours | 14.6 score on a scale | Standard Deviation 21.2 |
| Age Group; 30 to 34 | Difference of Pain Scores Between Different Age Groups | Mean pain score; day 4 | 0.3 score on a scale | Standard Deviation 1.2 |
| Age Group; 35 to 40 | Difference of Pain Scores Between Different Age Groups | Mean pain score; 12 hours | 7.4 score on a scale | Standard Deviation 13.5 |
| Age Group; 35 to 40 | Difference of Pain Scores Between Different Age Groups | Mean pain score; day 4 | 3.7 score on a scale | Standard Deviation 7.6 |
| Age Group; 35 to 40 | Difference of Pain Scores Between Different Age Groups | Mean pain score; day 3 | 3.7 score on a scale | Standard Deviation 6.9 |
| Age Group; 35 to 40 | Difference of Pain Scores Between Different Age Groups | Mean pain score; day 2 | 3.6 score on a scale | Standard Deviation 7.7 |
| Age Group; 35 to 40 | Difference of Pain Scores Between Different Age Groups | Mean pain score; 4 hours | 7.4 score on a scale | Standard Deviation 12.1 |
p-value: 0.15Kruskal-Wallis
p-value: 0.36Kruskal-Wallis
p-value: 0.13Kruskal-Wallis
p-value: 0.55Kruskal-Wallis
p-value: 0.17Kruskal-Wallis
Other Pre-specified
Difference of Pain Scores Between Males and Females
Information about Visual Analogue Scale for rating pain scores: * minimum pain score on this scale is 0 and maximum is 100 * more the pain score; worse the pain * mean pain score difference between males and females at different time intervals was assessed * scale is divided into 4 segments: 0 to 24 (no or mild pain), 25 to 49 (moderate pain), 50 to 74 (severe pain); 75 to 100 (extreme pain).
Time frame: 4 hours, 12 hours, day 2, day 3, and day 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group or Group I or Calcium Hydroxide Group | Difference of Pain Scores Between Males and Females | Day 2 | 7.8 score on a scale | Standard Deviation 11 |
| Control Group or Group I or Calcium Hydroxide Group | Difference of Pain Scores Between Males and Females | 12 hours | 11.6 score on a scale | Standard Deviation 14.5 |
| Control Group or Group I or Calcium Hydroxide Group | Difference of Pain Scores Between Males and Females | Day 3 | 5.8 score on a scale | Standard Deviation 8.9 |
| Control Group or Group I or Calcium Hydroxide Group | Difference of Pain Scores Between Males and Females | Day 4 | 5 score on a scale | Standard Deviation 9.2 |
| Control Group or Group I or Calcium Hydroxide Group | Difference of Pain Scores Between Males and Females | 4 hours | 9.8 score on a scale | Standard Deviation 11.9 |
| Experimental Group or Group II or Propolis Group | Difference of Pain Scores Between Males and Females | Day 4 | 0.70 score on a scale | Standard Deviation 2.1 |
| Experimental Group or Group II or Propolis Group | Difference of Pain Scores Between Males and Females | 4 hours | 10.4 score on a scale | Standard Deviation 16.9 |
| Experimental Group or Group II or Propolis Group | Difference of Pain Scores Between Males and Females | 12 hours | 8.8 score on a scale | Standard Deviation 15.2 |
| Experimental Group or Group II or Propolis Group | Difference of Pain Scores Between Males and Females | Day 2 | 2.3 score on a scale | Standard Deviation 5.8 |
| Experimental Group or Group II or Propolis Group | Difference of Pain Scores Between Males and Females | Day 3 | 1.40 score on a scale | Standard Deviation 4 |
p-value: 0.412Wilcoxon (Mann-Whitney)
p-value: 0.94Wilcoxon (Mann-Whitney)
p-value: 0.035Wilcoxon (Mann-Whitney)
p-value: 0.023Wilcoxon (Mann-Whitney)
p-value: 0.02Wilcoxon (Mann-Whitney)