Bovine Pericardium Membrane Versus Native Collagen Membrane in Conjunction With Sticky Bone Graft in Treatment of Class II Furcation Defects in Lower Molars.

NCT06681532 | Active Not Recruiting

• 1 other identifier: A05030240M
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Materials and methods: Twenty five patients (n=25) were selected from the outpatient clinic of the department of oral medicine and periodontology at Mansoura university's faculty of dentistry, 5 patients (n=5) were excluded as they didn't meet the inclusion criteria or met one or more of the exclusion criteria. The participants 20 patients exhibiting one buccal or lingual mandibular molar furcation defect were assigned into two treatment groups: group I (control group), group II (study group), 10 patients in each group. Patients in group I will be treated with open flap debridement, native collagen membrane and bovine bone graft particles. Patients in group II will be treated with open flap debridement, bovine pericardium membrane and bovine bone graft particles. Periodontal assessment (plaque index (PI), gingival index (GI), horizontal clinical attachment level (HCAL), vertical clinical attachment level (VCAL), gingival recession (REC) and probing depth (PD)) will be evaluated at baseline, 3 months and 6 months after periodontal treatment. Radiographic assessment using CBCT (bone loss in the horizontal direction (BL-H), bone loss in vertical direction (BL-V), length of the root trunk (RT), width of furcation entrance (FW) will be evaluated at baseline and 6 months after periodontal treatment.

Conditions

Furcation Defects

Outcome Measures

Primary Outcomes (2)

• Clinical ( Horizontal clinical attachment level [HCAL] )

  Is measured with Naber's probe, measure the depth of Furcation.

  6 months

• Radiographic ( Bone loss in the horizontal direction [BL-H] )

  Using the CBCT axial view to measure the distance between the outer root surface and the inter-radicular bone.

  6 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Are treated with open flap debridement, native collagen membrane and bovine bone graft particles.

Procedure: Native collagen membrane and bovine bone graft in treatment of class II furcation defects in lower molars

Study group

EXPERIMENTAL

Are treated with open flap debridement, bovine pericardium membrane and bovine bone graft particles.

Procedure: Bovine pericardium membrane and bovine bone graft in treatment of class II furcation defects in lower molars

Interventions

Native collagen membrane and bovine bone graft in treatment of class II furcation defects in lower molars PROCEDURE

The bovine bone graft particles will be mixed with concentrated growth factor (CGF) to form sticky bone, the furcation defect area will be condensed with the mixture and covered completely with native collagen membrane.

Control group

Bovine pericardium membrane and bovine bone graft in treatment of class II furcation defects in lower molars PROCEDURE

the bovine bone graft particles will be mixed with concentrated growth factor (CGF) to form sticky bone, the furcation defect area will be condensed with the mixture and covered completely with bovine pericardium membrane.

Study group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Display a buccal or lingual class II furcation defect (Hamp et al. classification) in their lower molars.
• The tooth with a horizontal clinical attachment level (HCAL) greater than 3mm and a probing depth (PD) greater than or equal to 6mm in the mid-buccal or mid-lingual sites.
• Have not undergone any periodontal treatment in the past 6 months.
• A plaque index score (PI) below 1 at surgery, assessed using the Ramfjord teeth.

You may not qualify if:

• Patients with class I or class III furcation defects.
• Systemic disease contraindicating periodontal surgery.
• Taking any medication that may have an impact on their periodontal health within the last 6 months.
• Smoking.
• Being pregnant or lactating.
• Teeth with periapical lesions and teeth with mobility.
• Third molars or teeth with improper endodontic or restorative treatment.
• Patients with furcation caries, metal crowns in the furcation area or amalgam fillings near the alveolar crest.

Sponsors & Collaborators

• Ibrahim Ahmed Zein Elabdin Ahmed: lead

Study Sites (1)

Faculty of dentistry , Mansoura university

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Furcation Defects

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ibrahim A Zein Elabdin

  Mansoura university Faculty of dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: BDS, Principal Investigator, Oral Medicine, and Periodontology Department.

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 8, 2024
• Study Start: September 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

EG (1)