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ACTIVE NOT RECRUITING
NCT06663995
NA

Evaluation of Locally Delivered Propolis Gels in Periodontitis

Sponsor: Ain Shams University

View on ClinicalTrials.gov

Summary

Assess the efficacy of locally delivered propolis gel as an adjunct to scaling and root planning in management of Stage II, Grade B periodontitis . Subjects and Methods I. Patients' selection: Thirty-two (32) patients were recruited from the outpatient clinic of Oral Medicine, Periodontology, and Oral Diagnosis department, Faculty of Dentistry, Ain Shams University. This study was designed as a randomized, controlled, 2-parallel arm, triple blinded, single center clinical trial. Thirty-two eligible patients with stage II and Grade B periodontitis were randomly assigned into 2 groups: * Group 1 (intervention group) was treated with SRP combined with intrasulcular application of 1% Propolis gel. * Group 2 (control group) was treated with SRP combined with intrasulcular application of placebo gel.

Official title: Evaluation of Locally Delivered Propolis Gel As an Adjunct to Nonsurgical Periodontal Therapy in the Management of Periodontitis: a Randomized Controlled Clinical Study with Biochemical Assessment

Key Details

Gender

All

Age Range

30 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2023-09-17

Completion Date

2024-12

Last Updated

2024-10-29

Healthy Volunteers

Yes

Interventions

DRUG

Study Group

It will include 16 patients with periodontitis stage II, grade B, at least 2 sites with pocket PD = 4-5 mm and CAL = 3-4 mm each will receive non-surgical periodontal therapy followed by application of propolis gel. After baseline assessment, at the same day the included participants will receive full mouth one stage debridement using hand instruments and ultrasonic scalers under local anesthesia -if needed- for patient's comfort. 2- Oral Hygiene Instructions Participants will be provided with a toothpaste, a medium toothbrush, a written oral hygiene instruction brochure (Brushing twice daily for 4-weeks using Modified Bass technique and interdental flossing). 3-Base line visit (Local delivery application): Propolis gel will be applied by syringe with blunt tip gently and removed slowly in order not to harm the tissue for group 1 patients (Test group) after phase 1 therapy at the second day (48 hours) following non-surgical periodontal therapy

DRUG

Control (placebo) group

After baseline assessment, at the same day the included participants will receive full mouth one stage debridement using hand instruments and ultrasonic scalers under local anesthesia -if needed- for patient's comfort. 2- Oral Hygiene Instructions Participants will be provided with a toothpaste, a medium toothbrush, a written oral hygiene instruction brochure (Brushing twice daily for 4-weeks using Modified Bass technique and interdental flossing).

Locations (1)

faculty of dentistry Ain Shams University

Cairo, Egypt