NCT06986525

Brief Summary

This prospective clinical study aims to evaluate and compare the effectiveness of coronally advanced flap (CAF) and tunnel techniques, both combined with platelet-rich fibrin (PRF), in the treatment of multiple Miller Class I-II gingival recessions. Eleven participants with bilateral defects will be treated using a split-mouth design. Periodontal parameters will be assessed at baseline, 3 months, and 6 months.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

August 17, 2025

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

May 9, 2025

Last Update Submit

August 13, 2025

Conditions

Keywords

gingival recessionsplatelet rich fibrinroot coverage

Outcome Measures

Primary Outcomes (1)

  • Change in Recession Height (RH)

    Recession height will be measured in millimeters from the cementoenamel junction to the gingival margin using a periodontal probe at baseline and 6 months postoperatively.

    Baseline and 6 Months

Secondary Outcomes (1)

  • Change in Clinical Attachment Level (CAL)

    Baseline, 3 Months, and 6 Months

Study Arms (2)

CAF + PRF

EXPERIMENTAL

This group will receive coronally advanced flap (CAF) surgery combined with platelet-rich fibrin (PRF) for the treatment of multiple gingival recessions.

Procedure: CAF with PRF

Tunnel + PRF

EXPERIMENTAL

This group will receive tunnel surgical technique combined with platelet-rich fibrin (PRF) for the treatment of multiple gingival recessions.

Procedure: Tunnel with PRF

Interventions

CAF with PRFPROCEDURE

Coronally advanced flap technique will be performed to reposition the gingival margin coronally. Platelet-rich fibrin (PRF) membranes will be placed over the exposed root surfaces and stabilized with sutures.

CAF + PRF

A tunnel or subgingival pouch will be created using microsurgical instruments without vertical incisions. Platelet-rich fibrin (PRF) membranes will be inserted into the tunnel and the gingival tissue will be advanced coronally and sutured to cover the recession.

Tunnel + PRF

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or older
  • Systemically healthy individuals
  • Presence of bilateral Miller Class I-II multiple gingival recessions
  • Good oral hygiene and willingness to follow instructions
  • Signed informed consent

You may not qualify if:

  • Use of tobacco or smoking
  • Pregnancy or lactation
  • Presence of systemic diseases affecting periodontal health
  • Use of medications that may affect healing (e.g., corticosteroids)
  • Periodontal surgery in the same area within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University, Faculty of Dentistry, Periodontology

Denizli, 20160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

Hypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Gizem TORUMTAY CİN, Assoc. Prof. Dr.

    Pamukkale University Faculty of Dentistry, Department of Periodontology

    STUDY DIRECTOR

Central Study Contacts

Necati Zavrak, RA

CONTACT

Gizem Torumtay Cin, Assoc. Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The clinical examiner who recorded the outcome measures was blinded to the type of surgical technique applied on each side.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Split-mouth randomized design. Each participant receives both interventions, one per side of the mouth.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

May 9, 2025

First Posted

May 23, 2025

Study Start

August 15, 2025

Primary Completion

March 15, 2026

Study Completion

March 15, 2026

Last Updated

August 17, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

This study does not plan to share individual participant data (IPD).

Locations