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Evaluation of Buccal Pedicle Flap, Connective Tissue Graft and Acellular Dermal Matrix for Volumetric Augmentation of Peri-implant Mucosa

NCT06479733 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-06-28

No results posted yet for this study

Summary

The aim of the study is to evaluate the efficacy of different soft tissue grafting techniques including buccal pedicle flap alone, free connective tissue graft and acellular dermal matrix for volumetric augmentation of peri-implant mucosa during the second stage implant surgery.

Conditions

  • Soft Tissue Augmentation Around Dental Implants

Interventions

PROCEDURE

buccal pedicle flap

For the first group (buccal pedicle flap group), outlining the full-thickness palatal flap 1 mm greater than the diameter of the underlying cover screw will be done, making a partial incision at the hinge portion of the created mini-pedicle flap to facilitate buccal rolling, de-epithelializing the mini-pedicle flap, then two small vertical incisions will be performed similarly mesial and distal to the screw border as wide as possible preserving the papilla and extending labially to include all the keratinized mucosa, elevating a full-thickness flap, then rolling of the pedicle flap into the created buccal pouch. The flap will be then sutured all around in place using a 5/0 vicryl suture

PROCEDURE

connective tissue graft

For the second group (free CTG group), masticatory mucosa on the palate between palatal raphae and maxillary posterior teeth is the most common location for the donor site for free CTG. It will be obtained by harvesting and de-epithelializing FGG asbeing a CTG derived from de-epithelialization of FGG mainly composed of lamina propria. Then the donor site will be covered by gel foam , sutured and protected.

PROCEDURE

acellular dermal matrix

* For the third group (ADM group) , The matrix will be trimmed so that it is gently adapted to the artificial envelope created on the buccal aspect of the ridge.The matrix will be trimmed and beveled to make its adaptation into the artificial envelope easier. Before placement, matrix will be hydrated for 10 minutes in fresh human blood collected after flap elevation in each patient. * For both second and third groups, graft will be carefully positioned under the buccal pouch, sutured to it, light pressure will be applied over the inserted graft with moist gauze for 10 minutes to minimize blood clot and dead space formation between the graft and the underlying bone.

PROCEDURE

control group

only placement of dental implant without soft tissue augmentation

Sponsors & Collaborators

  • Ghada Elhusseiny

    lead OTHER

Principal Investigators

  • Ghada A. Elhusseiny, PHD · Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-05-15
Completion
2024-06-22

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06479733 on ClinicalTrials.gov