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

NCT06479733 | Completed

• 1 other identifier: A02060722
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

soft tissue, augmentation, dental implants, connective tissue graft, alloderm, buccal pedicle flap

Outcome Measures

Primary Outcomes (2)

• Clinical measurement of soft tissue thickness

  At the baseline surgical visit, after local anesthetic administeration, the buccal peri-implant mucosal thickness (PMT) will be measured and recorded. An endodontic spreader will be gently inserted through the the surface of the mucosa to the bone, then the thickness measured by the spreader will be recorded using a digital caliper. The procedure will be reapeated after complete healing of the tissue

  6 months

• Esthetic evaluation

  According to Furhauser et al., 2005, esthetic scoring index called pink esthetic score (PES) index will be used in the current study. Seven points of evaluation (mesial papilla, distal papilla, soft tissue margins, soft tissue contouring, alveolar process, soft tissue color and soft tissue texture) of score 0,1,2: this index uses a maximum score of 14, representing optimum esthetic outcome with respect to the peri-implant soft tissue conditions. The PES index fulfilled important characteristics as inclusion of the peri-implant soft tissue and the restoration-inherent parameters.

  6 months

Secondary Outcomes (2)

• modified gingival index

  6 months

• modified plaque index

  6 months

Study Arms (4)

Group I (buccal pedicle flap group):

ACTIVE COMPARATOR

Includes 7 implants that will receive implants with soft tissue augmentation using buccal pedicle flap only.

Procedure: buccal pedicle flap

Group II (free CTG group):

ACTIVE COMPARATOR

Includes 7 implants that will receive implants with soft tissue augmentation using free CTG.

Procedure: connective tissue graft

Group III (ADM group):

ACTIVE COMPARATOR

Includes 7 implants that will receive implants with soft tissue augmentation using acellular dermal matrix.

Procedure: acellular dermal matrix

Group IV (control group):

SHAM COMPARATOR

Includes 7 implants that will receive implants without soft tissue augmentation.

Procedure: control group

Interventions

buccal pedicle flap PROCEDURE

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

Group I (buccal pedicle flap group):

connective tissue graft PROCEDURE

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.

Group II (free CTG group):

acellular dermal matrix PROCEDURE

* 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.

Group III (ADM group):

control group PROCEDURE

only placement of dental implant without soft tissue augmentation

Group IV (control group):

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age : above 20 years with single or multiple edentulous spaces
• Healthy periodontium.
• Thin periodontal phenotype.
• Non smoker.
• Adequate amount of basal bone to achieve primary stability.
• Patient who is able to understand and sign a written consent.
• Patient with good oral hygiene measures and plaque index\<1

You may not qualify if:

• Presence of systemic , local disease or any medication that would compromise healing.
• Presence of infection or pathology related to the surgical area.
• Pregnancy and lactation.

Sponsors & Collaborators

• Ghada Elhusseiny: lead

Study Sites (1)

faculty of Dentistry , Mansoura University

Al Mansurah, DK, 35516, Egypt

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ghada A. Elhusseiny, PHD

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: B.D.S (Mansoura University, 2014) Assistant lecturer at Oral Medicine, Periodontology , Diagnosis and Oral Radiology department (2021)

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: June 28, 2024
• Study Start: June 1, 2023
• Primary Completion: May 15, 2024
• Study Completion: June 22, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

EG (1)