NCT07591142

Brief Summary

This split-mouth randomized clinical trial aims to compare the effectiveness of titanium-prepared platelet-rich fibrin (T-PRF) and connective tissue graft (CTG) in the treatment of Miller Class I and II gingival recession using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique. Twenty systemically healthy adult participants with bilateral gingival recession defects will receive both interventions, with one side randomly assigned to T-PRF and the contralateral side assigned to CTG. Clinical outcomes including recession depth, attached gingival width, probing depth, relative attachment level, healing, and patient satisfaction will be evaluated over a 6-month follow-up period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

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
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

August 12, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 9, 2026

Last Update Submit

May 9, 2026

Conditions

Gingival RecessionGingival Diseases

Keywords

Titanium-prepared platelet-rich fibrinConnective tissue graftVISTA techniqueRoot coverage surgery

Outcome Measures

Primary Outcomes (2)

  • Gingival Recession Depth

    Change in gingival recession depth measured in millimeters (mm) from the cementoenamel junction to the free gingival margin using a UNC-15 periodontal probe. Lower values indicate better root coverage outcomes.

    Baseline, 3 months, and 6 months postoperatively.

  • Width of Attached Gingiva

    Change in the width of attached gingiva measured in millimeters (mm) using a UNC-15 periodontal probe. Higher values indicate improved gingival tissue augmentation and periodontal stability.

    Baseline, 3 months, and 6 months postoperatively.

Secondary Outcomes (5)

  • Periodontal Probing Depth

    Baseline, 3 months, and 6 months postoperatively.

  • Relative Clinical Attachment Level

    Baseline, 3 months, and 6 months postoperatively.

  • Early Wound Healing Index

    1 week, 2 weeks, and 4 weeks postoperatively.

  • Patient Satisfaction

    3 months and 6 months postoperatively.

  • Postoperative Pain

    1 week and 2 weeks postoperatively.

Study Arms (2)

VISTA + Titanium-Prepared Platelet-Rich Fibrin (T-PRF)

EXPERIMENTAL

Sites allocated to the test group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique in combination with titanium-prepared platelet-rich fibrin (T-PRF). T-PRF membranes will be prepared from autologous venous blood collected in titanium tubes and centrifuged according to a standardized protocol before placement beneath the tunneled gingival tissue.

Procedure: Titanium-Prepared Platelet-Rich Fibrin (T-PRF) with VISTA Technique

VISTA + Connective Tissue Graft (CTG)

ACTIVE COMPARATOR

Sites allocated to the control group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique in combination with an autogenous connective tissue graft (CTG) harvested from the palatal donor site and placed beneath the tunneled gingival tissue for root coverage.

Procedure: Connective Tissue Graft (CTG) with VISTA Technique

Interventions

Titanium-Prepared Platelet-Rich Fibrin (T-PRF) with VISTA TechniquePROCEDURE

The gingival recession defects assigned to the test group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique combined with titanium-prepared platelet-rich fibrin (T-PRF). T-PRF membranes will be prepared from the participant's autologous venous blood collected in titanium tubes and centrifuged according to a standardized protocol before placement beneath the tunneled flap.

VISTA + Titanium-Prepared Platelet-Rich Fibrin (T-PRF)
Connective Tissue Graft (CTG) with VISTA TechniquePROCEDURE

The gingival recession defects assigned to the control group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique combined with an autogenous connective tissue graft (CTG). The graft will be harvested from the palatal donor site and positioned beneath the tunneled gingival tissue to achieve root coverage and soft tissue augmentation.

VISTA + Connective Tissue Graft (CTG)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Systemically healthy
  • Bilateral gingival recession
  • Good oral hygiene

You may not qualify if:

  • Smokers
  • Pregnant/lactating women
  • Systemic diseases affecting healing
  • Previous surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dental Medicine

Damascus, Syria

Location

Related Publications (5)

  • Tunali M, Ozdemir H, Kucukodaci Z, Akman S, Yaprak E, Toker H, Firatli E. A novel platelet concentrate: titanium-prepared platelet-rich fibrin. Biomed Res Int. 2014;2014:209548. doi: 10.1155/2014/209548. Epub 2014 Jan 21.

    PMID: 24563860BACKGROUND

  • Miller PD Jr. A classification of marginal tissue recession. Int J Periodontics Restorative Dent. 1985;5(2):8-13. No abstract available.

    PMID: 3858267BACKGROUND

  • Cairo F, Nieri M, Cincinelli S, Mervelt J, Pagliaro U. The interproximal clinical attachment level to classify gingival recessions and predict root coverage outcomes: an explorative and reliability study. J Clin Periodontol. 2011 Jul;38(7):661-6. doi: 10.1111/j.1600-051X.2011.01732.x. Epub 2011 Apr 20.

    PMID: 21507033BACKGROUND

  • Chambrone L, Sukekava F, Araujo MG, Pustiglioni FE, Chambrone LA, Lima LA. Root-coverage procedures for the treatment of localized recession-type defects: a Cochrane systematic review. J Periodontol. 2010 Apr;81(4):452-78. doi: 10.1902/jop.2010.090540.

    PMID: 20367089BACKGROUND

  • Abdelhaleem M, Saleh W, Elmeadawy S. Treatment of gingival recession with vestibular incision subperiosteal tunnel access and advanced platelet-rich fibrin. BMC Oral Health. 2025 Jan 14;25(1):63. doi: 10.1186/s12903-024-05398-w.

    PMID: 39806320BACKGROUND

MeSH Terms

Conditions

Gingival DiseasesGingival Recession

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Rania Daadoush, DDs

    Damascus University

    PRINCIPAL INVESTIGATOR

  • Tarek Qasem, PhD

    Damascus University

    STUDY CHAIR

  • Saleh Al Kurdi, PhD

    Arab International University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2026

First Posted

May 15, 2026

Study Start

August 12, 2025

Primary Completion

January 12, 2026

Study Completion

April 25, 2026

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

SY(1)