The Use of Submucosal Dexamethasone After Periodontal Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Pain; Periodontitis; Patient Satisfaction; Periodontal Pocket; Swelling/ Edema
• Intervention / Treatment: Drug: submucosal 2 mL 0.9% isotonic sodium chloride application; Drug: submucosal 8 mg (2 mL) dexamethasone application

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Van, Turkey, 65080
    • Van Yüzüncü Yil University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. pocket depth ≥5mm;
2. systemically healthy;
3. without drug allergy;
4. without any blood disease;
5. not using medication (anti-platelet, anticoagulant, immunosuppressant medication);
6. received no any periodontal surgery in the last 6 months;

Exclusion Criteria:

1. poor oral hygiene;
2. smoking;
3. any systemic disease that would affect the surgical operation;
4. problem with the kidneys or adrenal glands;
5. connective tissue disease or immunodeficiency;
6. breastfeeding period or pregnancy.
7. high dental anxiety

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; 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; The mucoperiosteal flap was applied. After operation, 2 mL 0.9% isotonic sodium chloride was applied to the operation area as a control group; Other Names: Periodontal flap surgery
Active Comparator: Test Group; 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; The mucoperiosteal flap was applied. After operation, submucosal dexamethasone 8 mg (2 mL) was applied to the operation area as a test group.; Other Names: Periodontal flap surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

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

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University
• Investigators: Study Chair: Ahmet Cemil Talmac, PhD, Van Yüzüncü Yil University; Study Chair: Anas ALSAFADI, PhD, Special dental clinic; Principal Investigator: Dicle Altindal, DDS, Van Yüzüncü Yil University; Study Chair: Basem ALSHUJAA, PhD, Special dental clinic; Study Chair: Bilal Ege, PhD, Adiyaman University; Study Chair: Metin Calisir, PhD, Adiyaman University; Study Chair: Nazli Zeynep Alpaslan, PhD, Van Yüzüncü Yil University

Publications and helpful links

General Publications

• Vieth MP, Deas DE, Archontia Palaiologou A, Diogenes A, Mader MJ, Mealey BL. Effect of intravenous dexamethasone on postoperative pain and swelling following periodontal flap surgery: A randomized controlled trial of patient-centered outcomes. J Periodontol. 2022 Feb;93(2):237-245. doi: 10.1002/JPER.21-0153. Epub 2021 Jun 3.
• Steffens JP, Santos FA, Pilatti GL. Postoperative periodontal pain prevention using two dexamethasone medication protocols: a double-blind, parallel-group, placebo-controlled randomized clinical trial. Am J Dent. 2011 Dec;24(6):354-6.
• Aksoy F, Ege B. The effect of pretreatment submucosal injections of tramadol and dexamethasone on post-endodontic pain in mandibular molar teeth with symptomatic irreversible pulpitis: a randomized controlled clinical trial. Int Endod J. 2020 Feb;53(2):176-185. doi: 10.1111/iej.13246. Epub 2019 Nov 28.

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2021
• Primary Completion (Actual): April 29, 2022
• Study Completion (Actual): April 29, 2022

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: pain; dexamethasone; surgical flaps
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Edema; Periodontal Pocket; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 13.07.2021/08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No