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

NCT06060340 | Recruiting Early Phase 1

• 1 other identifier: PERIO 3-3-2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Furcation Defects

Outcome Measures

Primary Outcomes (1)

• Horizontal and Vertical Clinical Attachment Level (CAL)

  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.

  6 months

Secondary Outcomes (5)

• Radiographic Defect Fill

  6 months

• Probing Depth (PD)

  6 months

• Bleeding on Probing (BOP)

  6 months

• Plaque Index (PI)

  6 months

• Gingival Recession

  6 months

Study Arms (1)

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.

Drug: class II furcation defects management using propolis

Interventions

class II furcation defects management using propolis DRUG

A full thickness flap will be elevated using muco-periosteal elevator to gain full access to the furcation defect. Then granulomatous tissue will be debrided from the osseous defect and the root surfaces will be carefully scaled and root planed by ultrasonic and hand instruments. The diagnosis of the class II furcation defect was then confirmed using a Naber's probe. Propolis preparation: Pure propolis will then be mixed with saline to give a proper mix/consistency and applied to completely fill the furcation defect.

class II furcation defects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Smokers.
• Pregnancy and lactation.
• Stage 4 Grade C periodontitis.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, El-Manial, 11555, Egypt

RECRUITING

MeSH Terms

Conditions

Furcation Defects

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Ahmed Said Allam, BDs

CONTACT

01093929125; ahmed.allam@dentistry.cu.edu.eg

Manal Hosny, PHD

CONTACT

01118459362; manal.hosny@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2023
• First Posted: September 29, 2023
• Study Start: October 15, 2023
• Primary Completion: June 15, 2024
• Study Completion: October 15, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)