Clinical trial NCT06219473: Efficacy of Fascia Lata Allograft and Platelet Rich Fibrin on the Periodontal Phenotype Around Dental Implant
Official title: Efficacy of Fascia Lata Allograft and Platelet Rich Fibrin Versus Connective Tissue Graft on the Periodontal Phenotype Around Dental Implant in Upper Anterior Region: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Allograft
Keywords: Fascia lata allograft
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were classified into three main groups:

Group 1 (Study group) It includes eight patients seeking for implant placement in the upper anterior areas and implants will be placed with the application of fascia lata allograft membrane.

Group 2 (Study group) It includes eight patients seeking for implant placement in the upper anterior area and implants will be placed with the application of PRF.

Group 3 (Control group) It includes eight patients seeking for single implant placement at the upper anterior area and those patients will be received their implants with subepithelial connective tissue graft.
Primary purpose: TREATMENT

Brief summary: To compare between the efficacy of fascia lata allograft and platelet rich fibrin versus subepithelial connective tissue graft on periodontal phenotype (thickness and width of keratinized tissue, labial bone thickness) around dental implant in upper anterior region.

Detailed description: In order to evaluate the effectiveness of fascia lata allograft, platelet-rich fibrin, and subepithelial connective tissue graft on periodontal phenotype (including the thickness and width of keratinized tissue, as well as the thickness of labial bone) around dental implants in the upper anterior region, the purpose of this study is to compare the three types of grafts.

Eligibility criteria: Inclusion Criteria:

1. Patients with thin gingival biotype (gingival thickness was ≤1 mm)
2. The height of keratinized gingiva for the site selected should be ≥2 mm.
3. Ability to maintain good oral hygiene as evidenced in recall visits.

Exclusion Criteria:

1. Smoker patient and pregnant or lactating woman.
2. Patient with poor oral hygiene or active periodontal disease.
3. Traumatic occlusion or para-functional habits such as clenching or bruxism.
4. Patient with limited mouth opening

Primary outcomes:
measure: Pink aesthetic score
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Oral medicine and Periodontology at Kafr Elsheikh University
name: Enas elgendy, Prof
role: STUDY_CHAIR
References:
citation: Moraschini V, Kischinhevsky ICC, Sartoretto SC, Shibli JA, Dias AT, Sacco R, Yates J, Calasans-Maia MD. Is there any biomaterial substitute for peri-implant soft tissue phenotype modification? A network meta-analysis of the appraisal literature. Int J Oral Maxillofac Surg. 2022 Apr;51(4):526-534. doi: 10.1016/j.ijom.2021.07.005. Epub 2021 Aug 7.