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Platelet Rich Fibrin and Autologous Fibrin Glue

NCT03734458 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-10-08

No results posted yet for this study

Summary

Platelet-rich fibrin (PRF) and Autologous Fibrin Glue (AFG) are fibrin preparation derived from human blood samples and are used in regenerative dentistry.

Aim: The aim of this study is to evaluate the level of root coverage using PRF (+) AFG with a coronally advanced flap (CAF) or PRF only with a CAF compared to a sub-epithelial connective tissue graft (CTG) with a CAF for treating Class 1 and 2 gingival recession defects. Additionally, to evaluate the level of keratinized tissue tissue thickness and width using PRF (+) AFG with a CAF or PRF only with a CAF compared to CTG with CAF for Class 1 and 2 gingival recession defects.

Method: 48 patients with recession defects will be randomly divided into three different treatment groups. Treatment Group A (n=16) will consist of patients treated with PRF (+) AFG with a CAF, Group B (n=16) will consist of patients treated with PRF only with a CAF and Group C (n=16) will consits of patients treated with CTG with CAF as a control. Clinical measurements will be assessed at baseline and at 1 month and 6 months after the surgery. The clinical measurements that will be recorded, include probing depth, clinical attachment level, and gingval recession parameters. The gingival recession parameters include recession width, depth and thickness.

Conditions

  • Gingival Recession

Interventions

OTHER

Group A - PRF plus AFG with a CAF

Group A - PRF plus AFG with a CAF will be used surgically to cover the exposed roots.

OTHER

Group B - PRF only with a CAF

Group B - PRF only with a CAF will be used surgically to cover the exposed roots.

OTHER

Group C - CTG with a CAF

Group C - CTG with a CAF will be used surgically to cover the exposed roots.

Sponsors & Collaborators

Principal Investigators

  • Yogalakshmi Rajendran, BDS MS · UCSF School of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2021-01-31
Completion
2021-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03734458 on ClinicalTrials.gov