Clinical trial
Effect of Submucosal Dexamethasone on Postoperative Pain, Swelling and Trismus After Periodontal Surgery: Randomized Clinical Study
Name
13.07.2021/08
Description
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
Trial arms
Trial start
2021-08-12
Estimated PCD
2022-04-29
Trial end
2022-04-29
Status
Completed
Treatment
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.
Arms:
Test Group
Other names:
Periodontal flap surgery
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
Arms:
Control Group
Other names:
Periodontal flap surgery
Size
25
Primary endpoint
VAS
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
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
Patients were evaluated for swelling on the preoperative, the1st, 2nd, and 7th days after the operation
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}
Updated at
2023-11-09
1 organization
2 products
5 indications
Organization
Yuzuncu Yıl UniversityProduct
DexamethasoneIndication
Periodontal DiseaseIndication
PainIndication
EdemaIndication
Patient SatisfactionIndication
periodontitisProduct
Isotonic Sodium Chloride