Back to resultsPartial-thickness/Non-advanced vs. Full-thickness/MCAT Tunnelling for the Treatment of Multiple Gingival Recessions (Tun_RCT)
Primary Purpose
Gingival Recession
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Split-thickness non-advanced tunnel (Zabalegui et al. 1999)
Full-thickness coronally-advanced tunnel (Aroca et al. 2010)
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession
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.
Sites / Locations
- Universidad Complutense de MadridRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Split-thickness non-advanced tunnel (Zabalegui et al. 1999)
Full-thickness coronally-advanced tunnel (Aroca et al. 2010)
Arm Description
Modified Coronally Advanced Tunnel (MCAT)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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).
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).
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).
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).
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).
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.
Root-coverage Esthetic Score (RES)
Evaluated at 3- and 6-months according to Cairo et al. (2009).
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).
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).
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).
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).
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.
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).
Full Information
NCT ID
NCT05655247
First Posted
November 29, 2022
Last Updated
May 8, 2023
Sponsor
Universidad Complutense de Madrid
Collaborators
Osteology Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05655247
Brief Title
Partial-thickness/Non-advanced vs. Full-thickness/MCAT Tunnelling for the Treatment of Multiple Gingival Recessions
Acronym
Tun_RCT
Official Title
Partial-thickness/Non-advanced vs. Full-thickness/MCAT Tunnelling for the Treatment of Multiple Gingival Recessions: a Multi-centre Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
Osteology Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Split-thickness non-advanced tunnel (Zabalegui et al. 1999)
Arm Type
Experimental
Arm Title
Full-thickness coronally-advanced tunnel (Aroca et al. 2010)
Arm Type
Active Comparator
Arm Description
Modified Coronally Advanced Tunnel (MCAT)
Intervention Type
Procedure
Intervention Name(s)
Split-thickness non-advanced tunnel (Zabalegui et al. 1999)
Intervention Description
A split-thickness non-advanced tunnel will be performed according to Zabalegui et al. (1999).
Intervention Type
Procedure
Intervention Name(s)
Full-thickness coronally-advanced tunnel (Aroca et al. 2010)
Intervention Description
A full-thickness coronally-advanced tunnel (Modified Coronally Advanced Tunnel - MCAT) will be performed according to Aroca et al. (2010).
Primary Outcome Measure Information:
Title
Mean Root Coverage (MRC) (6 months)
Description
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.
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Mean Root Coverage (MRC) (3 months)
Description
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.
Time Frame
3 months after surgery
Title
Complete Root Coverage (CRC)
Description
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).
Time Frame
3 and 6 months after surgery
Title
Recession Reduction (RR)
Description
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).
Time Frame
3 and 6 months after surgery
Title
Contact-point/Papilla-tip (DCP) distance changes
Description
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).
Time Frame
3 and 6 months after surgery
Title
Keratinized Tissue Height (KTH) changes
Description
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).
Time Frame
3 and 6 months after surgery
Title
Probing Pocket Depth (PPD) changes
Description
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).
Time Frame
3 and 6 months after surgery
Title
Clinical Attachment Level (CAL) changes
Description
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).
Time Frame
3 and 6 months after surgery
Title
Dental hypersensitivity (DH)
Description
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.
Time Frame
3 and 6 months after surgery
Title
Root-coverage Esthetic Score (RES)
Description
Evaluated at 3- and 6-months according to Cairo et al. (2009).
Time Frame
3 and 6 months after surgery
Title
Digital Mean Root Coverage (dMRC)
Description
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).
Time Frame
3 and 6 months after surgery
Title
Digital Complete Root Coverage (dCRC)
Description
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).
Time Frame
3 and 6 months after surgery
Title
Digital Recession Reduction (dRR)
Description
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).
Time Frame
3 and 6 months after surgery
Title
Digital Contact-point/Papilla-tip (dDCP) distance changes
Description
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).
Time Frame
3 and 6 months after surgery
Title
Digital Gingival thickness (dGT)
Description
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.
Time Frame
3 and 6 months after surgery
Title
Digital Keratinized Tissue Height (dKTH) changes
Description
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).
Time Frame
3 and 6 months after surgery
Other Pre-specified Outcome Measures:
Title
PROMs - Pain
Description
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.
Time Frame
Just after surgery, 12 hours and 1, 2, 3, 4, 5, 6, 7, 14 days after surgery
Title
PROMs - Time to non-significant pain
Description
It will be defined as the time (days) to reach a pain VAS<10.
Time Frame
14 days after surgery
Title
PROMs - Number of analgesic tablets
Description
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.
Time Frame
14 days after surgery
Title
PROMs - Swelling
Description
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.
Time Frame
Just after surgery, 12 hours and 1, 2, 3, 4, 5, 6, 7, 14 days after surgery
Title
PROMs - Bleeding
Description
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.
Time Frame
Just after surgery, 12 hours and 1, 2, 3, 4, 5, 6, 7, 14 days after surgery
Title
PROMs - Discomfort during surgery
Description
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).
Time Frame
Just after surgery
Title
PROMs - Aesthetic consequences (self-evaluation)
Description
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.
Time Frame
6 months after surgery
Title
PROMs - Satisfaction (self-evaluation)
Description
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.
Time Frame
6 months after surgery
Title
PROMs - Oral Health Impact Profile-14 (OHIP-14)
Description
The OHIP-14 questionnaire will be evaluated at 1, 2, 3, 4, 5, 6, 7, 14 days and 6 months post-surgery.
Time Frame
1, 2, 3, 4, 5, 6, 7, 14 days, as well as 6 months, after surgery
Title
PROMs - Patient concerns with gingival recession
Description
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.
Time Frame
6 months after surgery
Title
Duration of surgery
Description
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).
Time Frame
During surgery
Title
Early Wound Healing
Description
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.
Time Frame
1 and 2 weeks after surgery
Title
Micro-vascularization (eco-doppler)
Description
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.
Time Frame
Just after surgery; 1, 2, 4 weeks after surgery; 3 and 6 months after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Romandini
Phone
+393801563046
Email
mario.romandini@gmail.com
Facility Information:
Facility Name
Universidad Complutense de Madrid
City
Taranto
ZIP/Postal Code
74123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Romandini
Email
mario.romandini@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
19968743
Citation
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.
Results Reference
background
PubMed Identifier
10635186
Citation
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.
Results Reference
background
Learn more about this trial
Partial-thickness/Non-advanced vs. Full-thickness/MCAT Tunnelling for the Treatment of Multiple Gingival Recessions
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