Condition as of 30/10/2018: Necrosis of pulp Previous condition: Domain in healthcare is dentistry and the condition we will be studying is Necrotic teeth with symptomatic apical periodontitis Oral Health Necrotic teeth with symptomatic apical periodontitis
Conditions
Interventions
Interventions as of 30/10/2018:
Control group: Calcium hydroxide
Intervention group: Propolis paste
Non-probability sampling will be done for sample recruitment and simple randomization for group allo
Sponsors
Dow University of Health Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participant inclusion criteria as of 30/10/2018: 1. Aged 20-40 years 2. Both male and female both 3. Single rooted Necrotic teeth with symptomatic or asymptomatic periapical periodontitis having visible periapical widening or radiolucency without bone expansion (PAI index 2, 3 and 4) 4. Teeth with favorable root morphology 5. Teeth with closed apex Previous participant inclusion criteria: 1. Aged 20-40 years 2. Both male and female both 3. Single rooted Necrotic teeth with symptomatic periapical periodontitis having visible periapical widening or radiolucency without bone expansion (PAI index 3 and 4) 4. Teeth with favorable root morphology 5. Teeth with closed apex
Exclusion criteria
Exclusion criteria: Participant exclusion criteria as of 30/10/2018: 1. Teeth with PAI index 1 and 5 2. Patients who are on antibiotics 3. Patient with recent trauma to the jaw 4. Teeth with open apex 5. Multi-rooted teeth 6. Vital teeth 7. Non-restorable teeth 8. Unfavorable root morphology (severely curved, dilacerated, severely sclerosed or obliterated) 9. Teeth associated with soft tissue abscess or swelling 10. Teeth with external and internal root resorption 11. Re-treatment cases 12. Periodontally compromised teeth (like mobile teeth and teeth with excessive bone loss) 13. Teeth requiring endodontic surgery 14. Teeth requiring non-surgical endodontic treatment of multiple teeth in the same or opposing quadrant 15. Medically compromised patients (ASA-III and above), patients with special communication needs or who doesn’t understand urdu or English language 16. Patients allergic to bee pollen or honey products Previous participant exclusion criteria: 1. Teeth with PAI index 1, 4 and 5 2. Patients who are on antibiotics 3. Patient with recent trauma to the jaw 4. Teeth with open apex 5. Multi-rooted teeth 6. Vital teeth 7. Non-restorable teeth 8. Unfavorable root morphology (severely curved, dilacerated, severely sclerosed or obliterated) 9. Teeth associated with soft tissue abscess or swelling 10. Teeth with external and internal root resorption 11. Re-treatment cases 12. Periodontally compromised teeth (like mobile teeth and teeth with excessive bone loss) 13. Teeth requiring endodontic surgery 14. Teeth requiring non-surgical endodontic treatment of multiple teeth in the same or opposing quadrant 15. Medically compromised patients (ASA-III and above), patients with special communication needs or who doesn’t understand urdu or English language 16. Patients allergic to bee pollen or honey products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure as of 30/10/2018: 1. Pain intensity measure: Visual Analogue Pain Scale. Difference of the pain scores between the two groups at different time intervals. Previous primary outcome measure: 1. Pain score is recorded by the patient using the Visual Analogue Scale (VAS scale) at four, 12, 24, 48 and 72 hours 2. Number of patients reaching the full followup period without taking oral analgesic is measured using the Visual Analogue Scale (statistically analysed during processing (after VAS scales are collected from all of the patients) to know how many patients reached the full follow up period of 72 hours without taking any oral analgesic) at 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures as of 30/10/2018: 1. 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 will indicate that pain has increased significantly and will be reported as "flare-up". 2. Difference of pain score between different time intervals will be 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. 3. Difference of pain scores and pain quality between males and females. The mean pain score difference between males and females at different time intervals will be assessed, frequencies of pain quality; no or mild pain, moderate pain, severe pain, and extreme pain will be reported according to gender. 4. Difference of pain scores and pain quality between different age groups. 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 will be assessed. Frequencies of pain quality; no or mild pain, moderate pain, severe pain, and extreme pain will be reported according to age group. Previous secondary outcome measures: Types of oral analgesic is measured using VAS scale (which is based on oral analgesics prescribed according to differing intensities of pain) and evaluating what type of analgesics are taken the most in each group at 72 hours | — |
Countries
Pakistan
Outcome results
None listed