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

Last updated: May 8, 2023
Sponsor: Universidad Complutense de Madrid
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

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

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

Clinical Study ID

NCT05655247
MR_03
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 atleast 18 years old and able and agreeing to sign a written informed consent form will bepotentially eligible for this trial. RT2 gingival recessions will be considered noteligible when associated with interproximal exposure of the CEJ (interdental gingivalrecession). In case of multiple RT1/RT2 recessions involving 2 or 3 teeth, at least 2 or 1 morenon-included adjacent teeth should respectively be present in order to guarantee a minimumof 4 adjacent teeth (including the included ones) in the region of interest (ROI) fordigital scanning. Patients fitting to all the inclusion criteria as above will be not included in the studyif they appear to be unable to attend to the study-related procedures (including thefollow-up visits) or if one or more of the following systemic or local exclusion criteriaare found in the enrollment phase.

Exclusion

Systemic primary exclusion criteria:

  • Compromised general health which contraindicates the study procedures (ASA IV-VIpatients);
  • 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, anddrug/alcohol abusers;
  • Pregnant or nursing women; Local primary exclusion criteria:
  • History of previous periodontal surgery (mucogingival or other) on the teeth to beincluded;
  • Patients having had surgical soft tissue augmentation procedures in the ROI within theprevious 12 months;
  • Furcation involvement in the teeth to be included;
  • Presence of severe tooth malposition, rotation or clinically significantsuper-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 thedentition (FMPS < 20% and FMBS < 20%);
  • Persistence of uncorrected gingival trauma from toothbrushing.

Study Design

Total Participants: 34
Treatment Group(s): 2
Primary Treatment: Full-thickness coronally-advanced tunnel (Aroca et al. 2010)
Phase:
Study Start date:
January 05, 2023
Estimated Completion Date:
December 30, 2027

Study 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.

Connect with a study center

  • Universidad Complutense de Madrid

    Taranto, 74123
    Italy

    Active - Recruiting

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