Ireland
--:--IST
Active, not recruiting Not applicable

Evaluation of Locally Delivered Propolis Gels in Periodontitis

NCT06663995 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2023-09-17
Last updated
2024-10-29

Condition(s) studied

Periodontal Diseases

Investigational drug(s) / intervention(s)

Study GroupControl (placebo) group

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

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).

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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
50 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 1-Both genders aged from 30-50 years 2- Systemically healthy patients as evidenced by (modified Cornell medical index) (Pendleton et al., 2004). 3- Patients with Stage II, Grade B Periodontitis, Test sites at least 2 sites have Propping depth (PD)= 4-5 mm or Clinical attachment loss (CAL)= 3-4mm. 4- Patient with no history of periodontal therapy or use of antibiotics or anti-inflammatory in the preceding 6 months. 5- Patient willing to comply with oral hygiene instructions Exclusion Criteria: * 1-Patients with known allergy to propolis. 2- Smokers or Alcoholics patients. 3- Pregnant and lactating females.

Primary outcome measure(s)

  • Regarding clinical periodontal parameters as a primary objective. — The following clinical parameters will be recorded for the individuals preoperatively and 3 and 6 months postoperatively.
    Probing pocket depth will be measured from the gingival margin to the base of the periodontal pocket to the nearest mm. with use of periodontal probe.

Trial sites (1)

FacilityCityRegionStatus
faculty of dentistry Ain Shams University Cairo Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06663995 on ClinicalTrials.gov ↗ ← All trials in Egypt