Clinical and Radiographic Outcomes of Class II Furcation Defects Management Using Propolis: A Case Series

Early Phase 1

Recruiting

• Conditions: Furcation Defects
• Interventions: Drug: class II furcation defects management using propolis

• Registration Number: NCT06060340
• Lead Sponsor: Cairo University

Brief Summary

Furcation involvement represents a challenge for treatment to many periodontists due to many factors including access, morphology, and variations of anatomical features of the furcation area. Furcation involvement treatment includes non-surgical periodontal therapy, resective surgery and regenerative surgery, regenerative therapy utilizing different graft materials and membranes is of high cost and research for new materials that can be cost-effective and available for all patients is continuing, propolis have been shown to be cost-effective therapy for bone and wound healing.

Detailed Description

Propolis is a natural resinous product of the bee workers collected from trees to use it to stick their hives and form a coat to protect their hives from all sources of bacteria and invasions. Propolis is composed of more than 300 compounds, the most important of them are flavonoids like CAPE (caffeic acid phenyl ester). Propolis have shown anti-inflammatory, anti-oxidant, anti-bacterial, anti-fungal, anti-viral and more importantly regenerative effect and bone formation capabilities.

Study Timeline

• Study First Submitted: 2023-09-23
• Study First Submitted QC: 2023-09-23
• Study First Posted: 2023-09-29
• Study Start: 2023-10-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-14
• Primary Completion: 2024-06-15
• Study Completion: 2024-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Inclusion criteria:

  1. Lower molars with class II furcation defects.
  2. Full mouth plaque score (FMPS )<20% at baseline.
  3. Full mouth bleeding score (FMBS )<10% at baseline.
  4. Systemically healthy.
  5. Cooperative patients.

Exclusion Criteria

• Exclusion criteria:

  1. Smokers.
  2. Pregnancy and lactation.
  3. Stage 4 Grade C periodontitis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
class II furcation defects	class II furcation defects management using propolis	Inclusion criteria: 1. Lower molars with class II furcation defects. 2. Full mouth plaque score (FMPS )\<20% at baseline. 3. Full mouth bleeding score (FMBS )\<10% at baseline. 4. Systemically healthy. 5. Cooperative patients. Exclusion criteria: 1. Smokers. 2. Pregnancy and lactation. 3. Stage 4 Grade C periodontitis.

Primary Outcome Measures

Name	Time	Method
Horizontal and Vertical Clinical Attachment Level (CAL)	6 months	Measured from the CEJ to the bottom of the gingival sulcus using Naber's periodontal probe.; Measured from the CEJ to the bottom of the gingival sulcus using William's periodontal probe.

Secondary Outcome Measures

Name	Time	Method
Bleeding on Probing (BOP)	6 months	BOP score will be assessed as the number of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized periodontal probe with a controlled (∼25 g) force to the bottom of the sulcus at six sites (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, disto-lingual) on all present teeth
Gingival Recession	6 months	Measured from the cementoenamel junction to the gingival margin using a William's graduated periodontal probe. The probe will be inserted into the sulcus gently parallel to the long axis of the tooth
Radiographic Defect Fill	6 months	The depth of Furcation defect will be measured from the Furcation to the base of the defect at baseline and after six months to detect the amount of bone fill. Individually customized bite blocks will be created for the patients using alginate impression material and acrylic resin. Parallel-angle technique will be used to obtain standardized radiographs
Plaque Index (PI)	6 months	PI will be assessed using a standardized periodontal probe to agitate the gingival margin and assessing the presence or absence of plaque at the margin. This will be recorded at 4 sites per tooth on all teeth
Probing Depth (PD)	6 months	Measured from the gingival margin to the bottom of the gingival sulcus using William's periodontal probe with the probe inserted parallel to the long axis of the tooth

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Cairo, El-Manial, Egypt