The Use of Submucosal Dexamethasone After Periodontal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-12

Study Completion Date

2022-04-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Inflammatory Stress and Periodontal Tissue Destruction

NCT06092853

Oxidative Stress Inflammation

COMPLETED

Chemerin, Fetuin-A, IL-34 and IL-13 Levels in Diabetic Periodontitis Patients

NCT06135532

Periodontitis Diabetes Mellitus, Type 2

COMPLETED NA

FM-SRP and Tooth Extraction Improve Type 2 Diabetes Mellitus in Periodontitis

NCT02874963

Periodontitis Type 2 Diabetes Mellitus

UNKNOWN NA

Use of Ozone Gel as an Antimicrobial in Treatment of Periodontitis

NCT05905445

Periodontal Pocket Periodontitis

COMPLETED PHASE1

Antibiotic, Gingival-biopsy, and Oral-smear Samples.

NCT04172207

Anti-bacterial Agents Chromosome-defective Micronuclei Cytology +1 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Periodontal Pocket Pain Swelling/ Edema Patient Satisfaction Periodontitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

submucosal 2 mL 0.9% isotonic sodium chloride application

Intervention Type DRUG

The mucoperiosteal flap was applied. After operation, 2 mL 0.9% isotonic sodium chloride was applied to the operation area as a control group

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

Group Type ACTIVE_COMPARATOR

submucosal 8 mg (2 mL) dexamethasone application

Intervention Type DRUG

The mucoperiosteal flap was applied. After operation, submucosal dexamethasone 8 mg (2 mL) was applied to the operation area as a test group.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Periodontal flap surgery Periodontal flap surgery

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes