Comparing two surgical techniques for treating gum recession

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial randomly assigns participants to receive either a split-thickness non-advanced tunnel technique or a full-thickness coronally-advanced tunnel technique for the treatment of multiple gingival recessions. The study is designed as a multi-centric, superiority trial with a 1:1 allocation ratio, and it will assess the mean root coverage at 6 months post-treatment by a blinded outcome assessor. The trial aims to determine which surgical approach is more effective in achieving root coverage in patients with specific types of gingival recessions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Universidad Complutense de Madrid
  Taranto, Italy Recruiting

Study contacts

• Study coordinator: Mario Romandini
• Email: mario.romandini@gmail.com
• Phone: +393801563046

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Root coverage using different restorative materials in Class V lesions

  This study tests whether using glass ionomer cement, resin composite, or no restoration before root coverage surgery helps people with gum recession and neck lesions

  Recruiting Adiyaman University · Adıyaman, Merkez · NCT07687654

• Volume-stable collagen matrix vs graft for multiple gingival recessions

  This study tests whether a volume-stable collagen matrix can cover exposed roots as well as a traditional graft, in adults with multiple gingival recessions.

  Recruiting University of Sao Paulo · Ribeirão Preto, São Paulo · NCT07613775

• Gingival recession and its effect on oral health-related quality of life

  This project will see how common gingival recession is and whether it affects oral health-related quality of life in adults aged 18–45 who visit a tertiary dental center in Haryana.

  Recruiting Postgraduate Institute of Dental Sciences Rohtak · Rohtak, Haryana · NCT07557277

• Comparing a new 3D tunneling technique with a modified coronally advanced tunnel plus connective tissue graft for treating multiple RT2 gingival recession.

  This trial will try a new 3D tunneling surgical technique versus a modified coronally advanced tunnel with connective tissue graft to improve root coverage in adults who have multiple RT2 gingival recessions.

  Recruiting Cairo University · Cairo, AlManial · NCT07526259

• Using 3D dental imaging to lower gum recession during aligner treatment

  This test tries to see if planning aligner treatment with 3D CBCT imaging instead of 2D images can reduce gum recession for adults undergoing dental arch expansion.

  Recruiting University of Liege · Liège, Liege · NCT07513792

• Gum recession in adults with and without prior orthodontic treatment

  We will test which patient and tooth factors increase the chance of gum recession in adults who have or have not had orthodontic treatment.

  Recruiting Universitaire Ziekenhuizen KU Leuven · Leuven · NCT07445555

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.