Partial-thickness/Non-advanced vs. Full-thickness/MCAT Tunnelling for the Treatment of Multiple Gingival Recessions

NCT05655247 | Recruiting

• 1 other identifier: MR_03
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Included patients will be randomly allocated to the test (split-thickness non-advanced tunnel - Zabalegui et al. 1999) or to the control group (full-thickness coronally-advanced tunnel - MCAT - Aroca et al. 2010).

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Mean Root Coverage (MRC) (6 months)

  Defined as the percentage of root coverage in the mid-buccal aspect obtained with respect to baseline. The MRC will be measured as a percentage (% mm, with probe) 6 months after surgery. Considering the study will also include RT2 gingival recessions (we expect CRC not possible in some cases), the linear 6 months MRC will be evaluated as the primary outcome of the study.

  6 months after surgery

Secondary Outcomes (15)

• Mean Root Coverage (MRC) (3 months)

  3 months after surgery

• Complete Root Coverage (CRC)

  3 and 6 months after surgery

• Recession Reduction (RR)

  3 and 6 months after surgery

• Contact-point/Papilla-tip (DCP) distance changes

  3 and 6 months after surgery

• Keratinized Tissue Height (KTH) changes

  3 and 6 months after surgery

Other Outcomes (13)

• PROMs - Pain

  Just after surgery, 12 hours and 1, 2, 3, 4, 5, 6, 7, 14 days after surgery

• PROMs - Time to non-significant pain

  14 days after surgery

• PROMs - Number of analgesic tablets

  14 days after surgery

Study Arms (2)

Split-thickness non-advanced tunnel (Zabalegui et al. 1999)

EXPERIMENTAL

Procedure: Split-thickness non-advanced tunnel (Zabalegui et al. 1999)

Full-thickness coronally-advanced tunnel (Aroca et al. 2010)

ACTIVE COMPARATOR

Modified Coronally Advanced Tunnel (MCAT)

Procedure: Full-thickness coronally-advanced tunnel (Aroca et al. 2010)

Interventions

Split-thickness non-advanced tunnel (Zabalegui et al. 1999) PROCEDURE

A split-thickness non-advanced tunnel will be performed according to Zabalegui et al. (1999).

Split-thickness non-advanced tunnel (Zabalegui et al. 1999)

Full-thickness coronally-advanced tunnel (Aroca et al. 2010) PROCEDURE

A full-thickness coronally-advanced tunnel (Modified Coronally Advanced Tunnel - MCAT) will be performed according to Aroca et al. (2010).

Full-thickness coronally-advanced tunnel (Aroca et al. 2010)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Compromised general health which contraindicates the study procedures (ASA IV-VI patients);
• Systemic diseases/medications which could influence the outcome of the therapy (e.g., uncontrolled diabetes mellitus);
• Current smokers (self-reported, any type of smoking), users of chewing tobacco, and drug/alcohol abusers;
• Pregnant or nursing women;
• History of previous periodontal surgery (mucogingival or other) on the teeth to be included;
• Patients having had surgical soft tissue augmentation procedures in the ROI within the previous 12 months;
• Furcation involvement in the teeth to be included;
• Presence of severe tooth malposition, rotation or clinically significant super-eruption in the teeth to be treated;
• Presence of fixed or removable prosthesis in the area to be treated;
• Presence of RT3 gingival recessions in the same surgical area of the treatment.
• Not able to achieve good oral hygiene and control gingivitis in the whole of the dentition (FMPS \< 20% and FMBS \< 20%);
• Persistence of uncorrected gingival trauma from toothbrushing.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Osteology Foundation: collaborator

Study Sites (1)

Universidad Complutense de Madrid

Taranto, 74123, Italy

RECRUITING

Related Publications (2)

• Aroca S, Keglevich T, Nikolidakis D, Gera I, Nagy K, Azzi R, Etienne D. Treatment of class III multiple gingival recessions: a randomized-clinical trial. J Clin Periodontol. 2010 Jan;37(1):88-97. doi: 10.1111/j.1600-051X.2009.01492.x. Epub 2009 Nov 30.

  PMID: 19968743 BACKGROUND

• Zabalegui I, Sicilia A, Cambra J, Gil J, Sanz M. Treatment of multiple adjacent gingival recessions with the tunnel subepithelial connective tissue graft: a clinical report. Int J Periodontics Restorative Dent. 1999 Apr;19(2):199-206.

  PMID: 10635186 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Central Study Contacts

Mario Romandini

CONTACT

+393801563046; mario.romandini@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 19, 2022
• Study Start: January 5, 2023
• Primary Completion: December 30, 2024
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

IT (1)