Comparison of De-Epithelialized Gingival Graft With or Without Platelet Rich Fibrin in Multiple Gingival Recessions

NCT ID: NCT06509867

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-30

Study Completion Date

2021-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to compare the clinical efficacy and patient reported outcome measures of de-epithelialized gingival graft (DGG) with or without platelet rich fibrin on treatment of multiple adjacent gingival recessions with coronally advanced flap (CAF) technique.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Fifteen patients with split-mouth multiple gingival recessions affecting at least 3 adjacent teeth will be treated with either DGG or DGG+PRF. Recession depth(RD) and width(RW), probing depth(PD), clinical attachment level(CAL), keratinized tissue width (KTW), gingival thickness(GT), and percentage of root coverage (RC%) will be evaluated at 1, 3 and 6 months postoperatively. For patient reported outcome measurements, oral health impact factor-14 (OHIP-14) scores, postoperative pain, bleeding, discomfort and painkiller consumption will be recorded.

A total of 15 patients will surgically treated with coronally advanced flap (CAF) associated with de-epithelialized gingival graft. Groups were defined as DGG and DGG+PRF:

DGG Group (n=15): de-epithelialized subepithelial connective tissue grafts + coronally advanced flap DGG+PRF Group (n=15): de-epithelialized subepithelial connective tissue grafts+ L-Platelet Rich Fibrin + Coronally advanced flap

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gingival Recession, Generalized

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A total of 15 patients were surgically treated with coronally advanced flap (CAF) associated with de-epithelialized gingival graft. Groups were defined as DGG and DGG+PRF:

DGG Group (n=15): de-epithelialized subepithelial connective tissue grafts + coronally advanced flap DGG+PRF Group (n=15): de-epithelialized subepithelial connective tissue grafts+ L-Platelet Rich Fibrin + Coronally advanced flap
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
All clinical measurements will be measured and recorded by the blinded researcher. Treatment assignment and surgeries will have been unknown to this examiner. For statistically analysis, groups will be anonymized.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Platelet rich fibrin

de-epithelialized subepithelial gingival grafts+ L-Platelet Rich Fibrin + Coronally advanced flap

Group Type EXPERIMENTAL

DGG+PRF

Intervention Type PROCEDURE

de-epithelialized subepithelial connective tissue grafts+ L-Platelet Rich Fibrin + Coronally advanced flap

de-epithelialized gingival grafts

de-epithelialized gingival grafts + coronally advanced flap

Group Type ACTIVE_COMPARATOR

DGG

Intervention Type PROCEDURE

de-epithelialized subepithelial connective tissue grafts+ Coronally advanced flap

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DGG+PRF

de-epithelialized subepithelial connective tissue grafts+ L-Platelet Rich Fibrin + Coronally advanced flap

Intervention Type PROCEDURE

DGG

de-epithelialized subepithelial connective tissue grafts+ Coronally advanced flap

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

platelet rich fibrin de-epithelialized gingival graft

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Age \> 18 years Systemically healthy and non-smoker Full-mouth plaque index and full-mouth gingival index score\< 20% No mucogingival surgery experience at operation area No active periodontal disease Patients who have not received orthodontic treatment

Exclusion Criteria

Pregnancy and lactation Bruxism or occlusal trauma Medical contradictions and for periodontal plastic surgery (i.e. mental disorders) Medication intake
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kutahya Health Sciences University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Berceste Guler

Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gazi University Faculty of Dentistry

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.

Reference Type BACKGROUND
PMID: 20590963 (View on PubMed)

Zucchelli G, Mele M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Coronally advanced flap with and without vertical releasing incisions for the treatment of multiple gingival recessions: a comparative controlled randomized clinical trial. J Periodontol. 2009 Jul;80(7):1083-94. doi: 10.1902/jop.2009.090041.

Reference Type BACKGROUND
PMID: 19563288 (View on PubMed)

Kuka S, Ipci SD, Cakar G, Yilmaz S. Clinical evaluation of coronally advanced flap with or without platelet-rich fibrin for the treatment of multiple gingival recessions. Clin Oral Investig. 2018 Apr;22(3):1551-1558. doi: 10.1007/s00784-017-2225-9. Epub 2017 Oct 20.

Reference Type BACKGROUND
PMID: 29058084 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E.4712136290600/110

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.