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Evaluation of Locally Delivered Propolis Gels in Periodontitis

NCT06663995 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-10-29

No results posted yet for this study

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.

Conditions

  • Periodontal Diseases

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).

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-17
Primary Completion
2024-06-24
Completion
2024-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06663995 on ClinicalTrials.gov