Clinical trial
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
Name
KFSIRB200-87
Description
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.
Trial arms
Trial start
2024-02-01
Estimated PCD
2025-01-01
Trial end
2025-02-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Fascia lata membrane
novel allogenic derived acellular matrix produced from human fascia lata allograft
Arms:
Fascia Lata (Study group)
Other names:
Fascia lata allograft
Platlet Rich fibrin membrane
Platelet-rich fibrin (PRF) or leukocyte- and platelet-rich fibrin (L-PRF) is a derivative of PRF where autologous platelets and leukocytes are present in a complex fibrin matrix to accelerate the healing of soft and hard tissue
Arms:
PRF (Study group)
Other names:
Platlet Rich fibrin
subepithelial connective tissue graft
The connective tissue is generally taken from the hard palate, although it may be taken from other sites as well, such as the maxillary tuberosity area.
Arms:
Connective tissue Graft(Control group)
Other names:
Connective tissue graft
Size
24
Primary endpoint
Pink aesthetic score
6 Months
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients were classified into three main groups:\n\nGroup 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.\n\nGroup 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.\n\nGroup 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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}
Updated at
2024-01-23
1 organization
3 products
1 indication
Organization
Kafrelsheikh UniversityProduct
Fascia lata membraneIndication
Allograft