NCT06135662

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of two different surgical techniques, the Coronally Advanced Flap (CAF) and the Tunnel Technique (TT) with Connective Tissue Grafts (CTG), in treating mandibular gingival recession. This study, focusing on healthy patients with RT1 and RT2 gingival recessions, aims to determine which surgical approach offers better root coverage for mandibular recession defects. Additionally, it seeks to understand the effects of these techniques on aspects such as keratinized tissue gain, vestibular depth, gingival thickness, and patient-reported outcomes. Participants in this trial will undergo one of the two surgical procedures and are expected to attend a total of six assessment visits. Researchers will compare the results from both groups, those treated with CAF and those with TT+CTG, to discern if one method is superior in achieving more effective root coverage, enhanced aesthetic appearance, and reduced discomfort associated with gingival recession.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

November 12, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

December 11, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2025

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

November 12, 2023

Last Update Submit

March 7, 2024

Conditions

Gingival Recession Localized Moderate

Keywords

RT1RT2CAFTunnel TechniqueConnective Tissue GraftGingival RecessionsCTG

Outcome Measures

Primary Outcomes (1)

  • Mean Root Coverage (MRC)

    he Mean Root Coverage measures the percentage of exposed tooth root that has been covered by gum tissue after surgery, compared to before the treatment.

    At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation

Secondary Outcomes (4)

  • Vestibular depth (VD)

    At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation

  • Complete Root Coverage (CRC)

    At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation

  • change in Keratinized Tissue Width (KT)

    At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation

  • change in gingival thickness (GT)

    At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation

Study Arms (2)

CAF + CTG

ACTIVE COMPARATOR

This arm involves patients treated with the Coronally Advanced Flap (CAF) technique, a recognized method for treating gingival recession. As an active comparator, this arm serves to compare the effectiveness and outcomes of CAF against the alternative surgical method used in the study.

Procedure: CAF + CTG

Tunnel Technique + CTG

ACTIVE COMPARATOR

Patients in this arm receive the Tunnel Technique (TT) with Connective Tissue Grafts (CTG). Also an established method for gingival recession treatment, this arm acts as an active comparator to assess and compare the effectiveness of TT+CTG against the CAF technique.

Procedure: Tunnel Technique + CTG

Interventions

CAF + CTGPROCEDURE

Surgical techniques for mandibular gingival recession: coronally advanced flap + connective tissue graft. Participants undergo initial evaluations, including periodontal exams and digital imaging, followed by standardized pre-operative preparations. Post-surgery, uniform care includes pain management and oral hygiene instructions, with follow-ups to monitor healing and assess outcomes. Primary and secondary outcomes, like root coverage and patient-reported satisfaction, are consistently measured across groups. Standardized data collection and analysis procedures ensure reliable, comparable results, facilitating an effective comparison of the surgical methods' efficacy.

CAF + CTG
Tunnel Technique + CTGPROCEDURE

Surgical techniques for mandibular gingival recession: tunnel technique + connective tissue graft. Participants undergo initial evaluations, including periodontal exams and digital imaging, followed by standardized pre-operative preparations. Post-surgery, uniform care includes pain management and oral hygiene instructions, with follow-ups to monitor healing and assess outcomes. Primary and secondary outcomes, like root coverage and patient-reported satisfaction, are consistently measured across groups. Standardized data collection and analysis procedures ensure reliable, comparable results, facilitating an effective comparison of the surgical methods' efficacy.

Tunnel Technique + CTG

Eligibility Criteria

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

You may qualify if:

  • ≥18 years; periodontally and systemically healthy
  • presence of RT1 and RT2 gingival recession defects
  • recession in the mandibular arch
  • recession ≥ 2mm in depth at the buccal aspect
  • full-mouth plaque and bleeding score ≤ 20%
  • no previous periodontal surgery
  • presence of identifiable cemento-enamel junction (CEJ) (a step ≤1mm at the CEJ and/or presence of root abrasion, but with identifiable CEJ, will be accepted).

You may not qualify if:

  • smokers ≥10 cigarettes a day
  • contraindications for periodontal surgery
  • medications known to affect the gingiva or interfere with wound healing
  • pregnancy
  • active orthodontic therapy
  • caries or restorations in the area to be treated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UIC Barcelona - Clinica Universitaria de Odontologia

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

Related Publications (2)

  • Zucchelli G, De Sanctis M. Treatment of multiple recession-type defects in patients with esthetic demands. J Periodontol. 2000 Sep;71(9):1506-14. doi: 10.1902/jop.2000.71.9.1506.

    PMID: 11022782BACKGROUND

  • Cairo F, Nieri M, Cattabriga M, Cortellini P, De Paoli S, De Sanctis M, Fonzar A, Francetti L, Merli M, Rasperini G, Silvestri M, Trombelli L, Zucchelli G, Pini-Prato GP. Root coverage esthetic score after treatment of gingival recession: an interrater agreement multicenter study. J Periodontol. 2010 Dec;81(12):1752-8. doi: 10.1902/jop.2010.100278. Epub 2010 Jul 14.

    PMID: 20629546RESULT

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Gonzalo Blasi, DDS MS

    UIC Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gonzalo Blasi, DDS MS

CONTACT

+34 620387688gonzaloblasi@uic.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Head Staff

Study Record Dates

First Submitted

November 12, 2023

First Posted

November 18, 2023

Study Start

December 11, 2023

Primary Completion

April 10, 2025

Study Completion

June 10, 2025

Last Updated

March 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)