NCT06509867

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

1.4 years

First QC Date

July 15, 2024

Last Update Submit

August 5, 2024

Conditions

Gingival Recession, Generalized

Outcome Measures

Primary Outcomes (1)

  • percentage of root coverage

    Percentage of Root Coverage (RC%) were performed with the following formulas. RC%: \[(Preoperative RD-Postoperative RD)/ Preoperative RD\] x 100.

    at 6th month

Study Arms (2)

Platelet rich fibrin

EXPERIMENTAL

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

Procedure: DGG+PRF

de-epithelialized gingival grafts

ACTIVE COMPARATOR

de-epithelialized gingival grafts + coronally advanced flap

Procedure: DGG

Interventions

DGG+PRFPROCEDURE

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

Also known as: platelet rich fibrin
Platelet rich fibrin
DGGPROCEDURE

de-epithelialized subepithelial connective tissue grafts+ Coronally advanced flap

Also known as: de-epithelialized gingival graft
de-epithelialized gingival grafts

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Dentistry

Ankara, 06490, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 20590963BACKGROUND

  • 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.

    PMID: 19563288BACKGROUND

  • 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.

    PMID: 29058084BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

July 15, 2024

First Posted

July 19, 2024

Study Start

May 30, 2019

Primary Completion

October 30, 2020

Study Completion

April 30, 2021

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)