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

NCT06219473 | Unknown Phase 4

• 1 other identifier: KFSIRB200-87
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allograft

Keywords

Fascia lata allograft

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Fascia Lata (Study group)

EXPERIMENTAL

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.

Drug: Fascia lata membrane

PRF (Study group)

EXPERIMENTAL

It includes eight patients seeking for implant placement in the upper anterior area and implants will be placed with the application of PRF.

Drug: Platlet Rich fibrin membrane

Connective tissue Graft(Control group)

ACTIVE COMPARATOR

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.

Drug: subepithelial connective tissue graft

Interventions

Fascia lata membrane DRUG

novel allogenic derived acellular matrix produced from human fascia lata allograft

Also known as: Fascia lata allograft

Fascia Lata (Study group)

Platlet Rich fibrin membrane 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

Also known as: Platlet Rich fibrin

PRF (Study group)

subepithelial connective tissue graft 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.

Also known as: Connective tissue graft

Connective tissue Graft(Control group)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: Patients age ranged from 20 to 50
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Related 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.

  PMID: 34373184 BACKGROUND

Study Officials

• Enas elgendy, Prof

  Professor of Oral medicine and Periodontology at Kafr Elsheikh University

  STUDY CHAIR

Central Study Contacts

Ahmed Elhadidy, Msc

CONTACT

+201002698979; ahmed.elhadidyy.93@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer at Delta university for science and technology

Model Details: 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.

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 23, 2024
• Study Start: February 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share