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

Modified Vascularized Interpostional Periosteal Connective Tissue Graft Versus Xenogeneic Collagen Matrix for Soft Tissue Augmentation Around Implant in Esthetic Zone (Comparative Study)

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

Study Overview

• Status: Completed
• Conditions: Implant; Dental
• Intervention / Treatment: Procedure: connective tissue graft; Device: xenogenic collagen membrane

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt, 61517
    • hospital of faculty of dentistry, Minia university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: modified vestibular interpositional periosteal connective tissue graft; 10 patients received pedicled CTG (mVIP-CTG)	Procedure: connective tissue graft; 10 patients received mVIP-CTG
Experimental: Xenogenic Collagen Membrane; 10 patients received xenogenic collagen membrane	Device: xenogenic collagen membrane; 10 patients received XCM

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pink esthetic score	measurement of pink aesthetic using visual scale of pink asethetic score	baseline and 6 months

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: Heba Ah Abdel-maged, MSc, Minia university

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: connective tissue graft; implant; xenogenic membrane
• Other Study ID Numbers: 543/84/2021; clinical trial (Registry Identifier: Minia University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes