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

NCT ID: NCT06219473

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-02-01

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.

Conditions

Allograft

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fascia Lata (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 Type: EXPERIMENTAL

Fascia lata membrane

Intervention Type: DRUG

novel allogenic derived acellular matrix produced from human fascia lata allograft

PRF (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 Type: EXPERIMENTAL

Platlet Rich fibrin membrane

Intervention Type: DRUG

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

Connective tissue Graft(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.

Group Type: ACTIVE_COMPARATOR

subepithelial connective tissue graft

Intervention Type: DRUG

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.

Interventions

Fascia lata membrane

novel allogenic derived acellular matrix produced from human fascia lata allograft

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Fascia lata allograft; Platlet Rich fibrin; Connective tissue graft

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Radwan Elhadidy

assistant lecturer at Delta university for science and technology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enas elgendy, Prof

Role: STUDY_CHAIR

Professor of Oral medicine and Periodontology at Kafr Elsheikh University

Central Contacts

Ahmed Elhadidy, Msc

Role: CONTACT

ahmed.elhadidyy.93@gmail.com

+201002698979

References

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.

Reference Type: BACKGROUND

PMID: 34373184 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

KFSIRB200-87

Identifier Type: -

Identifier Source: org_study_id