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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: Split-thickness non-advanced tunnel (Zabalegui et al. 1999); Procedure: Full-thickness coronally-advanced tunnel (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.

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario Romandini; Phone Number: +393801563046; Email: mario.romandini@gmail.com

Study Locations

• Italy
  • Taranto, Italy, 74123
    • Recruiting
    • Universidad Complutense de Madrid
    • Contact: Mario Romandini; Email: mario.romandini@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Split-thickness non-advanced tunnel (Zabalegui et al. 1999)	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).
Active Comparator: Full-thickness coronally-advanced tunnel (Aroca et al. 2010); Modified Coronally Advanced Tunnel (MCAT)	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Root Coverage (MRC) (3 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) 3 months after surgery.	3 months after surgery
Complete Root Coverage (CRC)	Defined as the presence/absence of complete root coverage in the mid-buccal aspect. It will be measured at 3- and 6-months after surgery and evaluated as linear mid-buccal measurement (mm, with probe).	3 and 6 months after surgery
Recession Reduction (RR)	Defined as the reduction in recession in the mid-buccal aspect with respect to baseline. It will be calculated at 3- and 6-months after surgery and evaluated as linear mid-buccal measurement (mm, with probe).	3 and 6 months after surgery
Contact-point/Papilla-tip (DCP) distance changes	Defined as the change in the linear distance between the contact point and the top of papilla at the mesial aspect of each tooth (Aroca et al. 2010) with respect to baseline. It will be measured at 3- and 6-months after surgery and evaluated as linear measurement (mm, with probe).	3 and 6 months after surgery
Keratinized Tissue Height (KTH) changes	Defined as the linear changes in mid-buccal keratinized tissue height (distance from the gingival margin and the mucogingival junction) with respect to baseline. It will be calculated at 3- and 6-months after surgery and evaluated as linear mid-buccal measurement (mm, with probe).	3 and 6 months after surgery
Probing Pocket Depth (PPD) changes	Defined as the changes in PPD (distance from the gingival margin to the bottom of the probeable sulcus) with respect to baseline. It will be calculated at 3- and 6-months after surgery and evaluated only as linear mid-buccal measurement (mm, with probe).	3 and 6 months after surgery
Clinical Attachment Level (CAL) changes	Defined as the changes in CAL (distance from the CEJ to the bottom of the probeable sulcus) with respect to baseline. It will be calculated at 3- and 6-months after surgery and evaluated only as linear mid-buccal measurement (mm, with probe).	3 and 6 months after surgery
Dental hypersensitivity (DH)	Assessed by 10 s air spray applied to the buccal cervical area. It will be evaluated at baseline and at 3- and 6-months after surgery.	3 and 6 months after surgery
Root-coverage Esthetic Score (RES)	Evaluated at 3- and 6-months according to Cairo et al. (2009).	3 and 6 months after surgery
Digital Mean Root Coverage (dMRC)	Defined as the percentage of root surface coverage obtained with respect to baseline. The sMRC will be measured at 3- and 6-months after surgery. It will be assessed as buccal surface measurement (% mm2, digital assessment).	3 and 6 months after surgery
Digital Complete Root Coverage (dCRC)	Defined as the presence/absence of complete root surface coverage. It will be measured at 3- and 6-months after surgery and evaluated as buccal surface measurement (mm2, digital assessment).	3 and 6 months after surgery
Digital Recession Reduction (dRR)	Defined as the reduction in recession surface with respect to baseline. It will be calculated at 3- and 6-months after surgery and evaluated as buccal surface measurement (mm2, digital assessment).	3 and 6 months after surgery
Digital Contact-point/Papilla-tip (dDCP) distance changes	Defined as the changes in the area between the contact point and the top of papilla at the mesial aspect of each tooth with respect to baseline. It will be measured at 3- and 6-months after surgery and evaluated as area measurement (mm2, digital assessment).	3 and 6 months after surgery
Digital Gingival thickness (dGT)	It will be measured both at the gingival margin and 1-mm apically. It will be assessed as a mid-buccal thickness measurement (mm, digital assessment) at 3- and 6-months after surgery.	3 and 6 months after surgery
Digital Keratinized Tissue Height (dKTH) changes	Defined as the changes in keratinized tissue surface (surface delimited apico-coronally by the gingival margin and the mucogingival junction and mesio-distally by the projection of a line passing by the contact-point and perpendicular to the occlusal aspect of each tooth) with respect to baseline. It will be calculated at 3- and 6-months after surgery and evaluated as buccal surface measurement (mm2, digital assessment).	3 and 6 months after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMs - Pain	The patient will self-report on a 100-mm VAS scale ranging from 0 (no pain whatsoever) to 100 (worst pain imaginable) the perceived pain. The pain will be reported just after surgery, 12 hours post-operatively and 1, 2, 3, 4, 5, 6, 7, 14 days post-operatively in the evening, preferably at the same time.	Just after surgery, 12 hours and 1, 2, 3, 4, 5, 6, 7, 14 days after surgery
PROMs - Time to non-significant pain	It will be defined as the time (days) to reach a pain VAS<10.	14 days after surgery
PROMs - Number of analgesic tablets	The patient will document in the evening, preferably at the same time, the number of ibuprofen tablets taken each day from day-0 to day-7 and at day-14 post-surgery.	14 days after surgery
PROMs - Swelling	The patient will self-report on a 100-mm VAS scale ranging from 0 (no swelling whatsoever) to 100 (worst swelling imaginable) the perceived swelling. The swelling will be reported just after surgery, 12 hours post-operatively and 1, 2, 3, 4, 5, 6, 7, 14 days post-operatively in the evening, preferably at the same time.	Just after surgery, 12 hours and 1, 2, 3, 4, 5, 6, 7, 14 days after surgery
PROMs - Bleeding	The patient will self-report on a 100-mm VAS scale ranging from 0 (no bleeding whatsoever) to 100 (continuous copious bleeding) the perceived bleeding. The bleeding will be reported just after surgery, 12 hours post-operatively and 1, 2, 3, 4, 5, 6, 7, 14 days post-operatively in the evening, preferably at the same time.	Just after surgery, 12 hours and 1, 2, 3, 4, 5, 6, 7, 14 days after surgery
PROMs - Discomfort during surgery	The patient will answer on a 100-mm VAS scale just after the surgery to the following question: "How did you perceive the procedure?" (Burkhardt et al. 2015). The VAS scale will range from 0 (no problem whatsoever) to 100 (unbearable).	Just after surgery
PROMs - Aesthetic consequences (self-evaluation)	The patient will self-report on a 100-mm VAS scale ranging from 0 (terrible) to 100 (perfect) the perceived aesthetic of the included zone. The aesthetic self-evaluation will be completed 6 months post-surgery.	6 months after surgery
PROMs - Satisfaction (self-evaluation)	The patient will self-report on a 100-mm VAS scale ranging from 0 (terrible) to 100 (perfect) the overall satisfaction for the treatment of the included zone. The satisfaction self-evaluation will be completed at 6-months post-surgery.	6 months after surgery
PROMs - Oral Health Impact Profile-14 (OHIP-14)	The OHIP-14 questionnaire will be evaluated at 1, 2, 3, 4, 5, 6, 7, 14 days and 6 months post-surgery.	1, 2, 3, 4, 5, 6, 7, 14 days, as well as 6 months, after surgery
PROMs - Patient concerns with gingival recession	Patient concerns with gingival recession will be assessed with a condition-specific health-related quality-of-life instrument (Tonetti et al. 2018) assessing the level of concern in terms of aesthetics, sensitivity to cold, sensitivity to brushing, root/tooth wear, development of cavity and fear to lose the involved teeth using a questionnaire on a 5-point Likert scale at 6 months.	6 months after surgery
Duration of surgery	The time in minutes of the net (excluding time used for photographs or other non-surgery related things) duration of the surgery in the recipient site (after palate suture), from the first incision to the completion of the last suture (the composite stops placement in the control group will be considered within the duration of surgery).	During surgery
Early Wound Healing	It will be evaluated by the outcome assessor on a 100-mm VAS scale ranging from 0 (very bad) to 100 (very good). The early wound healing will be evaluated at 1 and 2 weeks post-surgery.	1 and 2 weeks after surgery
Micro-vascularization (eco-doppler)	It will be evaluated on patients treated in one of the centers, using a 3D printed stent, just after surgery, and at 1-, 2- and 4-week, as well as 3- and 6-months examinations, after-surgery.	Just after surgery; 1, 2, 4 weeks after surgery; 3 and 6 months after surgery

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Collaborators: Osteology Foundation

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): December 30, 2027

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: MR_03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No