Evaluation of Buccal Pedicle Flap, Connective Tissue Graft and Acellular Dermal Matrix for Volumetric Augmentation of Peri-implant Mucosa
NCT Number: NCT06479733
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Soft Tissue Augmentation Around Dental Implants
Interventions: PROCEDURE: buccal pedicle flap|PROCEDURE: connective tissue graft|PROCEDURE: acellular dermal matrix|PROCEDURE: control group
Sponsor: Ghada Elhusseiny
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-06-01
Completion Date: 2024-06-22
Locations: faculty of Dentistry , Mansoura University, Mansoura, DK, 35516, Egypt

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.

Primary Outcome Measures: 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 Outcome Measures: modified gingival index, 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., 6 months|modified plaque index, 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., 6 months