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CompletedNCT06808243Updated Feb 5, 2025

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

An interventional study of connective tissue graft and xenogenic collagen membrane in Dental and Implant, sponsored by Minia University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-02-05.

Sponsored by Minia University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was Sep 2024, 2 years 1 month ago, and no results have been posted to the registry.
  • Registered 1 year after the study started (first participant enrolled Jan 2024, registered Jan 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Dental
  • Implant

Keywords

  • implant
  • connective tissue graft
  • xenogenic membrane
03

In context

Lead sponsor

Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    modified vestibular interpositional periosteal connective tissue graft

    10 patients received pedicled CTG (mVIP-CTG)

    Procedure: connective tissue graft

  • Experimental
    Xenogenic Collagen Membrane

    10 patients received xenogenic collagen membrane

    Device: xenogenic collagen membrane

Interventions

  • Procedureconnective tissue graft

    10 patients received mVIP-CTG

  • Devicexenogenic collagen membrane

    10 patients received XCM

06

What researchers measure

Primary outcomes

  1. keratinized tissue thickness

    measurement of Kertinized tissue thickness around implant using endodontic file

    Time frame: baseline, 3 months, 6 months

  2. keratinized tissue width

    measurement of keratinized tissue width using graduated UNC-15 Probe

    Time frame: baseline, 3 months and 6 months

  3. buccal cortex thickness

    measurement of buccal cortex thickness using CBCT

    Time frame: baseline and 6 months

Secondary outcomes

  1. pink esthetic score

    measurement of pink aesthetic using visual scale of pink asethetic score

    Time frame: baseline and 6 months

07

Study locations

1 site
  • Hospital of faculty of dentistry, Minia university
    Minya, 61517, Egypt
08

References and documents

Study documents

  • Study protocol · Nov 21, 2021
  • Statistical analysis plan · Dec 25, 2024

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06808243
Lead sponsor
Minia University
Responsible party
heba ahmed abdelmaged (Teaching assistant, Minia University) — Principal investigator
First posted
Feb 5, 2025
Start date
Jan 1, 2024
Primary completion
Sep 1, 2024
Completion
Dec 30, 2024
Last update
Feb 5, 2025

Study contacts

Heba Ah Abdel-maged, MSc
principal investigator · Minia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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