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Is Therapeutic Elastic Bandage As Effective As Corticosteroids Following Third Molar Surgery?

Comparison Of The Effectiveness Of Submucosal Corticosteroid Injection And Elastic Therapeutic Bandage Applications On Pain, Swelling And Trismus After Surgical Removal Of Mandibular Third Molar Teeth

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04200885
Enrollment
52
Registered
2019-12-16
Start date
2019-05-02
Completion date
2019-11-21
Last updated
2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Third Molar Surgery

Keywords

Dexamethasone, Applied Kinesiology, Non-Steroidal Anti-Inflammatory Agents, Teeth, Impacted, Edema, Trismus, Postoperative Pain

Brief summary

In this study; Among the patients randomized because of severe postoperative sequelae expected as a result of radiological and clinical examinations; nonsteroid antiinflammatory drug prescribed group compared with preoperative single dose intraoral submucosal corticosteroid administration and therapeutic elastic bandage application considering inflammatory symptoms' severity and health related quality of life following surgical removal of impacted third molars. The study hypothesis was formed stating that corticosteroid injection and elastic bandage application would reduce the inflammatory symptoms more than NSAID.

Interventions

Patients were instructed to record the number of drugs they used until the second and seventh postoperative days.

DRUGDexamethasone 21-Phosphate

Injections were administered in the immediate preoperative period as a single shot.

DEVICETherapeutic Elastic Bandage

The bands' lengths were individually measured and divided into five equal parts up to 2/3 of their lengths to obtain fan-type shape.

Sponsors

Tokat Gaziosmanpasa University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Among the patients randomized because of severe postoperative sequelae expected as a result of radiological examination prior to surgical extraction of lower third molar teeth; postoperatively nonsteroid antiinflammatory drug prescribed group compared with preoperative single dose intraoral submucosal corticosteroid administration and postoperative therapeutic elastic bandage application.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Age between 18-65 years * American Society of Anesthesiologists (ASA) Class 1 physiological status * Consistent radiological and clinical data * Volunteered to participate in the study * Surgical difficulty score above 5 which was determined according to Pederson scale.

Exclusion criteria

* Being out of age range * Analgesic or antibiotic therapy history in last 30 days due to symptoms of related third molar * Smoking cigarette * Any pathology associated with impacted third molar * Active complaints on preoperative examination on the day of surgery * Immunosuppressed or diagnosed with malignancy * Diagnosed chronic diseases such as; Diabetes mellitus (DM), hypertension, cerebrovascular event, psychiatric diseases, coagulopathies * Autoimmune diseases * If total operation time exceeds 45 minutes * Patients who could not attend regular follow-up visits * Allergy to the medications prescribed or utilized in study protocol * Inconsistent clinical and radiological data

Design outcomes

Primary

MeasureTime frameDescription
Oral Analgesic Consumption-2Postoperative Seventh DayThe patients were asked to record the amounts of consumed analgesic tablets (tablets per day) between first and last follow up visits.
Oral Analgesic Consumption-1Postoperative Second DayThe patients were asked to record the amounts of consumed analgesic tablets (tablets per day) until first follow up visit.
Postoperative Pain Intensity-1Postoperative Second DayThe patients were asked to mark their pain intensities on a Numerical Rating Scale in which '0' means no pain, '5' means moderate pain and '10' means worst imaginable pain.
Postoperative Pain Intensity-2Postoperative Seventh DayThe patients were asked to mark their pain intensities on a Numerical Rating Scale in which '0' means no pain, '5' means moderate pain and '10' means worst imaginable pain.
Preoperative Pain IntensityOn the day of surgery preoperativelyThe patients were asked to mark their pain intensities on a Numerical Rating Scale in which '0' means no pain, '5' means moderate pain and '10' means worst imaginable pain on the day of surgery preoperatively.
Change From Baseline Maximal Mouth Opening on Postoperative Follow Up VisitsPreoperatively on the day of surgery, postoperative second and seventh days.All patients' maximal mouth opening were measured and recorded as the distance between upper and lower right central incisors.
Change From Baseline Facial Measurements on Postoperative Follow Up VisitsPreoperatively on the day of surgery, postoperative second and seventh days.Measurements were performed on the ipsilateral site between tragus and lateral commissura, lateral canthus and angle of mandible with a flexible ruler. The obtained values' average amounts were calculated and recorded for each patient.

Secondary

MeasureTime frameDescription
Oral Health Impact ProfilePreoperatively on the day of surgery, postoperative second and seventh days.Oral health-related quality of life was followed up with Oral Health Impaction Profile-14 questionnaire (Turkish Version). The investigators aimed to detect the alterations in quality of life due to surgical intervention and the other treatment modalities. The obtainable scores vary between 0-56 points. Lower scores indicate better postoperative physical and psychological conditions.
Postoperative Symptom Severity EvaluationPostoperative seventh day.Postoperative inflammatory symptoms were evaluated with the postoperative symptom severity scale at the end of the follow-up period individually. The scale scores vary between 0%-100%. The higher scores indicate that the individual experienced severe symptoms. The investigators aimed to detect the severity of symptoms from the point of the patient's view.
Wound Healing ScoresPostoperative second and seventh days.Extraction wound healing rates were evaluated by Landry's healing index. The index scores were classified as; 1. Very poor, 2. Poor, 3. Good, 4. Very Good and 5. Excellent.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026