Modified Periosteal Tissue Graft vs Collagen Matrix for Soft Tissue Augmentation Around Implants: A Comparative Study

Not Applicable

Completed

• Conditions: Dental; Implant

• Registration Number: NCT06808243
• Lead Sponsor: Minia University

Brief Summary

This clinical trial aims to evaluate the effectiveness of the Modified Vascularized Interpositional Periosteal Connective Tissue Graft (mVIP-CTG) compared to Xenogeneic Collagen Matrix (XCM) around immediate implant in esthetic zone . This study will assess outcomes such as keratinized tissue thickness, keratinized tissue width, pink esthetic score and radiographic buccal cortex thickness over a defined follow-up period. By comparing mVIP-CTG to XCM, the study seeks to determine which method provides superior clinical and aesthetic results for best soft tissue augmentation

Detailed Description

This study investigates two surgical techniques for managing peri-implant soft tissue deficiencies: the Modified Vascularized Interpositional Periosteal Connective Tissue Graft (VIP-CTG) and the Xenogeneic Collagen Matrix (XCM). Peri-implant soft tissue deficiencies, characterized by inadequate tissue volume or recession around dental implants, can lead to complications such as implant exposure, sensitivity, and aesthetic concerns. Conventional treatment methods aim to enhance soft tissue volume and improve the aesthetic and functional outcomes of implants.

The mVIP-CTG approach utilizes autogenous pedicle grafts to improve tissue thickness and width, potentially enhancing soft tissue integration and thickness around immediate implants. In contrast, XCM is a xenogenic membrane offering a minimally invasive alternative substitute for soft tissue regeneration.

The study design includes randomized assignment of participants to either the mVIP-CTG group or XCM group, with standardized surgical and follow-up protocols. Primary and secondary outcomes will include peri-implant soft tissue thickness, keratinized tissue width, pink esthetic score, and radiographic buccaal cortex thickness. Statistical analysis will evaluate the comparative effectiveness of both techniques in promoting peri-implant soft tissue regeneration and aesthetic recovery.

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-30
• Status Verified: 2025-01
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-31
• Last Update Submitted: 2025-01-31
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

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

Inclusion Criteria

• systemically healthy
• teeth indicated for extraction due to trauma or root fracture
• periodontally healthy
• Good oral health
• Selected patients of both sexes are 20-40 years old.

Exclusion Criteria

• parafunctional habits
• smoking, alcoholism
• pregnancy
• lactation
• untreated periodontal diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
keratinized tissue thickness	baseline, 3 months, 6 months	measurement of Kertinized tissue thickness around implant using endodontic file
keratinized tissue width	baseline, 3 months and 6 months	measurement of keratinized tissue width using graduated UNC-15 Probe
buccal cortex thickness	baseline and 6 months	measurement of buccal cortex thickness using CBCT

Secondary Outcome Measures

Name	Time	Method
pink esthetic score	baseline and 6 months	measurement of pink aesthetic using visual scale of pink asethetic score

Trial Locations

Locations (1)

Hospital of faculty of dentistry, Minia university; 🇪🇬 Minya, Egypt