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Efficacy of Fascia Lata Allograft and Platelet Rich Fibrin on the Periodontal Phenotype Around Dental Implant

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06219473
Enrollment
24
Registered
2024-01-23
Start date
2024-02-01
Completion date
2025-02-01
Last updated
2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allograft

Keywords

Fascia lata allograft

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.

Interventions

DRUGFascia lata membrane

novel allogenic derived acellular matrix produced from human fascia lata allograft

DRUGPlatlet 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

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.

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pink aesthetic score6 MonthsPink esthetic score The gingival response to a anterior esthetic evaluation is assessed by the Pink Esthetic Score (PES) from clinical photography

Contacts

Primary ContactAhmed Elhadidy, Msc
ahmed.elhadidyy.93@gmail.com+201002698979

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026