Xengenic Cortical Membranes Versus Connective Tissue Graft With Coronally Advanced Flap for the Treatment of Peri-implant Soft Tissue Dehiscences: A Randomized, Controlled Clinical Trial

Phase 2

Recruiting

• Conditions: Immediate Implant; Connective Tissue Graft
• Interventions: Device: Xengenic Cortical membranes; Procedure: connective tissue graft

• Registration Number: NCT06588998
• Lead Sponsor: Amr Anwar Mohamed Ellithy Yousef

Brief Summary

Peri-implant soft tissue dehiscences represent a common complication in implant dentistry, often leading to esthetic and functional challenges. Current treatment options, including Xengenic cortical membranes and connective tissue graft with coronally advanced flap, aim to promote soft tissue regeneration and improve clinical outcomes. However, there is a need for comparative studies to determine the optimal treatment modality for peri-implant soft tissue dehiscences.

Detailed Description

Aim: Comparing the effectiveness and patient outcomes of Xengenic cortical membranes versus connective tissue graft with coronally advanced flap for the treatment of peri-implant soft tissue dehiscences.

Study Timeline

• Study Start: 2024-06-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-05
• Last Update Submitted: 2024-09-05
• Study First Posted: 2024-09-10
• Last Update Posted: 2024-09-10
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Adults (20-50) years old. •peri-implant soft tissue dehiscence . •Thin gingival phenotype. •Optimal compliance as evidenced by no missing treatment appointments and positive attitude towards oral hygiene.

Exclusion Criteria

• •Medically compromised patients and systemic conditions precluding implant and periodontal surgery. •Smokers, diabetics, pregnant or lactating women. •History of chemotherapy, radiotherapy in head and/or neck region. •Bisphosphonate therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xengenic Cortical membranes	Xengenic Cortical membranes	-
connective tissue graft	connective tissue graft	-

Primary Outcome Measures

Name	Time	Method
peri implant soft tissue thickness	six months

Secondary Outcome Measures

Name	Time	Method
pink esthetic score	six months

Trial Locations

Locations (1)

TantaU; 🇪🇬 Tanta, Gharbia, Egypt