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

Official title

Partial-thickness/Non-advanced vs. Full-thickness/MCAT Tunnelling for the Treatment of Multiple Gingival Recessions: a Multi-centre Randomized Clinical Trial

Overview

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).

Detailed description

Design: Randomized, clinical, outcome-assessor blinded, multi-centric, superiority trial with two parallel groups and a 1:1 allocation ratio. The follow-up of individual patients will be 6 months (to be extended to 3/5 years if funding will be available)

Patients with a minimum of two-adjacent teeth with RT1 and/or RT2 gingival recessions (at least one with a depth \>2 mm) with indication for root coverage treatment will be included. RT2 gingival recessions will be considered not eligible when associated with interproximal exposure of the CEJ.

Mean root coverage (linear) at 6-months will be evaluated as the primary outcome by a blinded outcome assessor.

Interventions

• Procedure Split-thickness non-advanced tunnel (Zabalegui et al. 1999)
  A split-thickness non-advanced tunnel will be performed according to Zabalegui et al. (1999).
• Procedure Full-thickness coronally-advanced tunnel (Aroca et al. 2010)
  A full-thickness coronally-advanced tunnel (Modified Coronally Advanced Tunnel - MCAT) will be performed according to Aroca et al. (2010).

Primary outcome measures

• Mean Root Coverage (MRC) (6 months) [Time frame: 6 months after surgery]

Secondary outcome measures (12)

• Mean Root Coverage (MRC) (3 months) [Time frame: 3 months after surgery]
• Complete Root Coverage (CRC) [Time frame: 3 and 6 months after surgery]
• Recession Reduction (RR) [Time frame: 3 and 6 months after surgery]
• Contact-point/Papilla-tip (DCP) distance changes [Time frame: 3 and 6 months after surgery]
• Keratinized Tissue Height (KTH) changes [Time frame: 3 and 6 months after surgery]
• Probing Pocket Depth (PPD) changes [Time frame: 3 and 6 months after surgery]
• Clinical Attachment Level (CAL) changes [Time frame: 3 and 6 months after surgery]
• Dental hypersensitivity (DH) [Time frame: 3 and 6 months after surgery]
• Root-coverage Esthetic Score (RES) [Time frame: 3 and 6 months after surgery]
• Digital Mean Root Coverage (dMRC) [Time frame: 3 and 6 months after surgery]
• Digital Complete Root Coverage (dCRC) [Time frame: 3 and 6 months after surgery]
• Digital Recession Reduction (dRR) [Time frame: 3 and 6 months after surgery]

Eligibility criteria

Any patient having a minimum of two adjacent teeth with RT1 and/or RT2 gingival recessions (at least one with a depth >2 mm) with indication for root coverage treatment, being at least 18 years old and able and agreeing to sign a written informed consent form will be potentially eligible for this trial. RT2 gingival recessions will be considered not eligible when associated with interproximal exposure of the CEJ (interdental gingival recession).

In case of multiple RT1/RT2 recessions involving 2 or 3 teeth, at least 2 or 1 more non-included adjacent teeth should respectively be present in order to guarantee a minimum of 4 adjacent teeth (including the included ones) in the region of interest (ROI) for digital scanning.

Patients fitting to all the inclusion criteria as above will be not included in the study if they appear to be unable to attend to the study-related procedures (including the follow-up visits) or if one or more of the following systemic or local exclusion criteria are found in the enrollment phase.

Systemic primary exclusion criteria:

• 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;

Local primary exclusion criteria:

• 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.

Secondary exclusion criteria (after initial therapy is provided):

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Italy · 1 center

• Universidad Complutense de Madrid — Taranto

Publications

• 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
• 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

Identifiers

NCT: NCT05655247 · MR_03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗