Clinical trial NCT06119893: The Use of Submucosal Dexamethasone After Periodontal Surgery
Official title: Effect of Submucosal Dexamethasone on Postoperative Pain, Swelling and Trismus After Periodontal Surgery: Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Pocket
Pain
Swelling/ Edema
Patient Satisfaction
Periodontitis
Keywords: pain
dexamethasone
surgical flaps
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS
timeFrame: 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
measure: NRS-101
timeFrame: 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
measure: Swelling
timeFrame: Patients were evaluated for swelling on the preoperative, the1st, 2nd, and 7th days after the operation
Secondary outcomes:
measure: Trismus
timeFrame: It was evaluated for trismus on the preoperative, the 1st, 2nd, and 7th days after the operation
measure: Chewing efficiency
timeFrame: It was evaluated for chewing efficiency on the 1st, 2nd, and 7th days after the operation
measure: Healing of operation area
timeFrame: It was evaluated for healing of operation area on the 1st, 2nd, and 7th days after the operation
measure: Discomfort
timeFrame: It was evaluated for discomfort on the 1st, 2nd, and 7th days after the operation
measure: Analgesics consumed
timeFrame: The number of analgesics used each day during the first 7 days was noted by the patient in the pain diary
measure: General satisfaction
timeFrame: 14th day after operation
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yuzuncu Yil University
Study officials:
affiliation: Yuzuncu Yıl University
name: Dicle Altindal, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Special dental clinic
name: Anas ALSAFADI, PhD
role: STUDY_CHAIR
affiliation: Special dental clinic
name: Basem ALSHUJAA, PhD
role: STUDY_CHAIR
affiliation: Yuzuncu Yıl University
name: Ahmet Cemil Talmac, PhD
role: STUDY_CHAIR
affiliation: Adiyaman University
name: Bilal Ege, PhD
role: STUDY_CHAIR
affiliation: Adiyaman University
name: Metin Calisir, PhD
role: STUDY_CHAIR
affiliation: Yuzuncu Yıl University
name: Nazli Zeynep Alpaslan, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.