NCT06479733

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Ghada Elhusseiny · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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.

Detailed description

Soft tissue grafting around dental implants has been recommended to enhance functional, biological, and esthetic outcomes. As a thick peri-implant mucosa is of importance to prevent recession, color alterations, bone remodeling and promote "creeping attachment". Two major indications include the increase of the KM width and the increase of soft tissue volume using autogenous or alternative type grafts. Several techniques have been proposed to augment the volume of the mucosa to achieve the so-called pink esthetics: connective tissue grafts, lyophilized allogenic soft tissue grafts, porcine collagen matrix, free gingival grafts, a combination of grafting and vestibuloplasty, strip gingival autografts, tissue engineered fibroblasts, allograft, collagen matrices, and the use of the buccal pedicle flap. Among surgical techniques, the proposed modified buccal pedicle flap was demonstrated to perform well in terms of decreased morbidity, maintenance of blood supply, stabilization of the pedicle, superior haemostasis, and speed of treatment. However, a possible drawback may be related to the original thickness of the flap since a thin mucosa phenotype may be more prompt to perforation when in contact with a cross-linked collagen matrix. The autologous subepithelial connective tissue graft (sCTG) is generally regarded as the gold standard for soft tissue augmentation around natural teeth and dental implants. However, harvesting an autologous soft tissue graft necessarily entails additional preoperative preparation, a second surgical site, longer operative duration, and increased morbidity, regardless of the surgical technique employed and the expertise of the operator. Another alternative for autogenous grafting is the acellular dermal matrix (ADM) allograft that is derived from human skin. ADM, originally used for treating burn wounds , is an epithelium free, freeze-dried matrix containing types I and III collagen bundles where elastic fibers are its main components . ADM acts as a bioactive scaffold that integrates in host tissue and permits the migration of fibroblasts and epithelial and endothelial cells through vascular channels of the recipient sites . Since its initial use, ADM has been widely used in dental practice, in particular for soft tissue grafting of gingival recession or to change the quality of peri-implant/teeth mucosa.

Conditions

• Soft Tissue Augmentation Around Dental Implants

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-05-15
• Completion: 2024-06-22
• First posted: 2024-06-28
• Last updated: 2024-06-28

Locations

1 site across 1 country: Egypt