Evaluation of Buccal Pedicle Flap, Connective Tissue Graft and Acellular Dermal Matrix for Volumetric Augmentation of Peri-implant Mucosa
- Conditions
- Soft Tissue Augmentation Around Dental Implants
- Interventions
- Procedure: acellular dermal matrixProcedure: connective tissue graftProcedure: control groupProcedure: buccal pedicle flap
- Registration Number
- NCT06479733
- Lead Sponsor
- Ghada Elhusseiny
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- 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
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• 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group III (ADM group): acellular dermal matrix Includes 7 implants that will receive implants with soft tissue augmentation using acellular dermal matrix. Group II (free CTG group): connective tissue graft Includes 7 implants that will receive implants with soft tissue augmentation using free CTG. Group IV (control group): control group Includes 7 implants that will receive implants without soft tissue augmentation. Group I (buccal pedicle flap group): buccal pedicle flap Includes 7 implants that will receive implants with soft tissue augmentation using buccal pedicle flap only.
- Primary Outcome Measures
Name Time Method Esthetic evaluation 6 months 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.
Clinical measurement of soft tissue thickness 6 months 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
- Secondary Outcome Measures
Name Time Method modified gingival index 6 months Lobene developed the Modified Gingival Index (MGI), which changed the criteria of the Gingival Index by using a non-invasive (no probing) method and resetting the rating for mild and moderate inflammation. The following criteria are used in this manner:
0 = absence of inflammation;
1. = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary;
2. = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary;
3. = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary;
4. = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration.modified plaque index 6 months The modified plaque index was calculated using the approach reported by Mombelli et al. for plaque scoring as follows: Plaque was scored 0 if no plaque was detected, 1 if plaque was detected only by running a probe across a smooth surface of the abutment/implant, 2 if plaque cloud could be seen with the naked eye, and 3 if there was an abundance of soft matter.
Trial Locations
- Locations (1)
faculty of Dentistry , Mansoura University
🇪🇬Mansoura, DK, Egypt