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Completed

NCT Number: NCT06808243

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

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Key information

Conditions

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of faculty of dentistry, Minia university

Minya, 61517, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

connective tissue graft

Procedure

10 patients received mVIP-CTG

xenogenic collagen membrane

Device

10 patients received XCM

Primary outcomes

  1. keratinized tissue thickness

    Time frame: baseline, 3 months, 6 months

    measurement of Kertinized tissue thickness around implant using endodontic file

  2. keratinized tissue width

    Time frame: baseline, 3 months and 6 months

    measurement of keratinized tissue width using graduated UNC-15 Probe

  3. buccal cortex thickness

    Time frame: baseline and 6 months

    measurement of buccal cortex thickness using CBCT

Secondary outcomes

  1. pink esthetic score

    Time frame: baseline and 6 months

    measurement of pink aesthetic using visual scale of pink asethetic score

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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