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Completed

NCT Number: NCT04200885

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

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.

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Key information

Conditions

Third Molar Surgery Edema Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Spasm Stomatognathic Diseases Tooth Diseases Tooth, Impacted Trismus

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tokat Gaziosmanpasa University, Faculty of Dentistry

Tokat Province, 60100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dexketoprofen trometamol

Drug

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

Other names: Arveles 25 mg 20 tablets

Dexamethasone 21-Phosphate

Drug

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

Other names: Dekort 8mg/2ml Intramuscular (IM)/ Intravenous (IV)

Therapeutic Elastic Bandage

Device

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

Other names: Kinesio Tex Gold Fingerprint (FP)

Primary outcomes

  1. Preoperative Pain Intensity

    Time frame: On the day of surgery preoperatively

    The 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.

  2. Change From Baseline Maximal Mouth Opening on Postoperative Follow Up Visits

    Time frame: Preoperatively 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.

  3. Change From Baseline Facial Measurements on Postoperative Follow Up Visits

    Time frame: Preoperatively 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.

  4. Oral Analgesic Consumption-1

    Time frame: Postoperative Second Day

    The patients were asked to record the amounts of consumed analgesic tablets (tablets per day) until first follow up visit.

  5. Postoperative Pain Intensity-1

    Time frame: Postoperative Second Day

    The 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.

  6. Postoperative Pain Intensity-2

    Time frame: Postoperative Seventh Day

    The 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.

  7. Oral Analgesic Consumption-2

    Time frame: Postoperative Seventh Day

    The patients were asked to record the amounts of consumed analgesic tablets (tablets per day) between first and last follow up visits.

Secondary outcomes

  1. Wound Healing Scores

    Time frame: Postoperative 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.

  2. Oral Health Impact Profile

    Time frame: Preoperatively 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.

  3. Postoperative Symptom Severity Evaluation

    Time frame: Postoperative 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.

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 16, 2019
Registry last updated
Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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