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

NCT ID: NCT06808243

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-30

Brief Summary

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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

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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.

Conditions

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Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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modified vestibular interpositional periosteal connective tissue graft

10 patients received pedicled CTG (mVIP-CTG)

Group Type EXPERIMENTAL

connective tissue graft

Intervention Type PROCEDURE

10 patients received mVIP-CTG

Xenogenic Collagen Membrane

10 patients received xenogenic collagen membrane

Group Type EXPERIMENTAL

xenogenic collagen membrane

Intervention Type DEVICE

10 patients received XCM

Interventions

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connective tissue graft

10 patients received mVIP-CTG

Intervention Type PROCEDURE

xenogenic collagen membrane

10 patients received XCM

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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heba ahmed abdelmaged

Teaching assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heba Ah Abdel-maged, MSc

Role: PRINCIPAL_INVESTIGATOR

Minia University

Locations

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Hospital of faculty of dentistry, Minia university

Minya, , Egypt

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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clinical trial

Identifier Type: REGISTRY

Identifier Source: secondary_id

543/84/2021

Identifier Type: -

Identifier Source: org_study_id

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