NCT06808243

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
Last Updated

February 5, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

January 15, 2025

Last Update Submit

January 31, 2025

Conditions

Keywords

implantconnective tissue graftxenogenic membrane

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • pink esthetic score

    baseline and 6 months

Study Arms (2)

modified vestibular interpositional periosteal connective tissue graft

EXPERIMENTAL

10 patients received pedicled CTG (mVIP-CTG)

Procedure: connective tissue graft

Xenogenic Collagen Membrane

EXPERIMENTAL

10 patients received xenogenic collagen membrane

Device: xenogenic collagen membrane

Interventions

10 patients received mVIP-CTG

modified vestibular interpositional periosteal connective tissue graft

10 patients received XCM

Xenogenic Collagen Membrane

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of faculty of dentistry, Minia university

Minya, 61517, Egypt

Location

Study Officials

  • Heba Ah Abdel-maged, MSc

    Minia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant

Study Record Dates

First Submitted

January 15, 2025

First Posted

February 5, 2025

Study Start

January 1, 2024

Primary Completion

September 1, 2024

Study Completion

December 30, 2024

Last Updated

February 5, 2025

Record last verified: 2025-01

Locations