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

Allograft Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06219473
• Other study ID #: KFSIRB200-87
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 1, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: January 2024
• Source: Kafrelsheikh University
• Contact: Ahmed Elhadidy, Msc
• Phone: +201002698979
• Email: ahmed.elhadidyy.93[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: February 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Allograft

Intervention

Drug:
• Fascia lata membrane
novel allogenic derived acellular matrix produced from human 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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pink aesthetic score	Pink esthetic score The gingival response to a anterior esthetic evaluation is assessed by the Pink Esthetic Score (PES) from clinical photography	6 Months