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Clinical Trials/NCT06060340
NCT06060340RecruitingEarly Phase 1

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

Cairo University1 site in 1 country10 target enrollmentStarted: October 15, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Early Phase 1
Status
Recruiting
Enrollment
10
Locations
1
Primary Endpoint
Horizontal and Vertical Clinical Attachment Level (CAL)

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Inclusion criteria:
  • Lower molars with class II furcation defects.
  • Full mouth plaque score (FMPS )<20% at baseline.
  • Full mouth bleeding score (FMBS )<10% at baseline.
  • Systemically healthy.
  • Cooperative patients.

Exclusion Criteria

  • Exclusion criteria:
  • Pregnancy and lactation.
  • Stage 4 Grade C periodontitis.

Arms & Interventions

class II furcation defects

Experimental

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.

Intervention: class II furcation defects management using propolis (Drug)

Outcomes

Primary Outcomes

Horizontal and Vertical Clinical Attachment Level (CAL)

Time Frame: 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 Outcomes

  • Bleeding on Probing (BOP)(6 months)
  • Gingival Recession(6 months)
  • Radiographic Defect Fill(6 months)
  • Plaque Index (PI)(6 months)
  • Probing Depth (PD)(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Said Abd-El Azeem Allam

Principal Investigator

Cairo University

Study Sites (1)

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