The Use of Submucosal Dexamethasone After Periodontal Surgery

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effectiveness of submucosal 8 mg (2 mL) dexamethasone on postoperative pain, swelling, chewing efficiency, trismus, healing, and discomfort after periodontal flap surgery

Detailed Description
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Periodontitis is an oral inflamatuar disease caused by specific microorganisms, is characterized by attachment loss, alveolar bone resorption, pathological pocket formation. This disease causes deep periodontal pockets associated with deep intrabony defects as well as various clinical problems. For management overcome these problems, various approaches have been proposed in the treatment of periodontitis, including initial periodontal treatment such as scaling and root planing, followed by flap surgery, resective bone surgery and periodontal regeneration when applicable. However, periodontal flap surgery applied in these approaches causes undesirable side effects such as pain and swelling. To overcome these disorders, studies continue to investigate by using various medication regimens include pre, intra or post operative drugs. Dexamethasone is a synthetic steroidal anti-inflammatory drug used to control pain, swelling, and inflammation occurring in third molar surgeries, periodontal therapy and periodontal surgeries, implant surgery, and endodontic treatment. In the literature, dexamethasone application is frequently used in oral surgery before or after third molar tooth extraction. There is limited research on dexamethasone applications in periodontal flap surgery. lt has been evaluated the effectiveness of oral use of etoricoxib and dexamethasone in preventing pain after open flap debridement surgery. Some authors used 4 mg dexamethasone tablets before mucoperiosteal flap surgery and reported that the pain level in the dexamethasone group was lower than placebo at the 3rd hour. It has been reported positive results where preferred its use intravenously in the postoperative management of periodontal surgery. However, to the investigators knowledge, there is no study in the literature in which dexamethasone is applied submucosally after periodontal flap surgery. Accordingly, the hypothesis of this study was that submucosal application of dexamethasone in periodontal flap surgery would have a positive effect on pain and patient comfort. In light of all these scientific data, this study aimed to evaluate the effect of submucosal dexamethasone application periodontal flap surgery on postoperative pain, swelling, chewing efficiency, trismus, healing and discomfort.

Official Title
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Effect of Submucosal Dexamethasone on Postoperative Pain, Swelling and Trismus After Periodontal Surgery: Randomized Clinical Study

Conditions
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Periodontal Pocket, Pain, Swelling/ Edema, Patient Satisfaction, Periodontitis

Intervention / Treatment
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* Drug: submucosal 8 mg (2 mL) dexamethasone application
* Drug: submucosal 2 mL 0.9% isotonic sodium chloride application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pocket depth ≥5mm; systemically healthy; without drug allergy; without any blood disease; not using medication (anti-platelet, anticoagulant, immunosuppressant medication); received no any periodontal surgery in the last 6 months; Exclusion Criteria: poor oral hygiene; smoking; any systemic disease that would affect the surgical operation; problem with the kidneys or adrenal glands; connective tissue disease or immunodeficiency; breastfeeding period or pregnancy. high dental anxiety

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Patient received an indication periodontal flap surgery. In this randomized controlled split mouth study, the patient underwents periodontal flap surgery in their mandibular. Following local anesthesia (2% lidocaine and 1:100,000 epinephrine), sulcular incisions were made. Vertical incision was not used in any operation. The mucoperiosteal flap was elevated until the buccal and lingual bone defects were adequately exposed. Defects were thoroughly debrided firstly by using periodontal curettes, and then cleaned by piezoelectric ultrasonic scaler to ensure all granulation tissues were thoroughly removed. Buccal and lingual flaps were closed primarily. In the control group, 2 mL 0.9% isotonic sodium chloride (saline) with 27-gauge single-type disposable syringes was applied to the buccal surface of flap after the operation | Drug: submucosal 2 mL 0.9% isotonic sodium chloride application<br>* The mucoperiosteal flap was applied. After operation, 2 mL 0.9% isotonic sodium chloride was applied to the operation area as a control group<br>* Other names: Periodontal flap surgery;|
| Active Comparator: Test Group<br>Patient received an indication periodontal flap surgery. In this randomized controlled split mouth study, the patient underwents periodontal flap surgery in their mandibular. Following local anesthesia (2% lidocaine and 1:100,000 epinephrine), sulcular incisions were made. Vertical incision was not used in any operation. The mucoperiosteal flap was elevated until the buccal and lingual bone defects were adequately exposed. Defects were thoroughly debrided firstly by using periodontal curettes, and then cleaned by piezoelectric ultrasonic scaler to ensure all granulation tissues were thoroughly removed. Buccal and lingual flaps were closed primarily. In the test group, 8 mg (2 mL) submucosal dexamethasone with 27-gauge single-type disposable syringes was applied to the buccal surface of flap after the operation | Drug: submucosal 8 mg (2 mL) dexamethasone application<br>* The mucoperiosteal flap was applied. After operation, submucosal dexamethasone 8 mg (2 mL) was applied to the operation area as a test group.<br>* Other names: Periodontal flap surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | Visual analogue scale (VAS) was assessed to monitor the degree of pain.VAS is a scale that rates pain severity from 0 to 10. (0 = no pain to 10 = severe pain), | Every hour for the first 8 hours on the first day of the operation, and three times a day on the 2nd, 3rd, 4th and 7th days | 
| NRS-101 | 101-point numeric rate scale (NRS-101) was assessed to monitor the degree of pain. NRS-101 is a 101-point numerical ratio scale that rates pain severity from 0 to 100. (0 = no pain to 100 = severe pain), | Every hour for the first 8 hours on the first day of the operation, and three times a day on the 2nd, 3rd, 4th and 7th days | 
| Swelling | Linear measurements were taken for swelling with a millimeter tape measure. Measurements were made between the angle of the mandible and the mentus, labial commissure, nasal ala, outer corner of the eye and tragus. The average of these five measurements was noted. | Patients were evaluated for swelling on the preoperative, the1st, 2nd, and 7th days after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trismus | For trismus evaluation, mouth opening was measured using a millimetric ruler by measuring the distance between the mesial-incisal corners of the upper right and lower right central incisors at the maximum jaw opening while the patient was sitting upright. | It was evaluated for trismus on the preoperative, the 1st, 2nd, and 7th days after the operation | 
| Chewing efficiency | Chewing efficiency was scored by the patients as 1) very poor, 2) poor, 3) good, 4) very good and 5) excellent. | It was evaluated for chewing efficiency on the 1st, 2nd, and 7th days after the operation | 
| Healing of operation area | Healing at the operative site in terms of infection was scored by clinician as follows: 1) very poor, 2) poor, 3) good, 4) very good, and 5) excellent healing | It was evaluated for healing of operation area on the 1st, 2nd, and 7th days after the operation | 
| Discomfort | In the evaluation of discomfort, the four-point verbal rating scale (VRS-4) and a questionnaire questioning patient comfort were used. The questionnaire was scored with this four-point scoring system (Pain in this scoring: 1) none, 2) mild, 3) moderate, 4) severe). | It was evaluated for discomfort on the 1st, 2nd, and 7th days after the operation | 
| Analgesics consumed | The number of analgesics used was noted by the patient in the pain diary. | The number of analgesics used each day during the first 7 days was noted by the patient in the pain diary | 
| General satisfaction | On the day of removing suture, the patients' general satisfaction levels were measured with a 5-point scale ( 1) poor, 2) reasonable, 3) good, 4) very good and 5) excellent). | 14th day after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, dexamethasone, surgical flaps