Gingival RecessionTun_RCTNCT05655247
Partial-thickness/Non-advanced vs. Full-thickness/MCAT Tunnelling for the Treatment of Multiple Gingival Recessions
A study testing Split-thickness non-advanced tunnel (Zabalegui et al. 1999) and Full-thickness coronally-advanced tunnel (Aroca et al. 2010) in people with Gingival Recession, run by Universidad Complutense de Madrid at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Split-thickness non-advanced tunnel (Zabalegui et al. 1999) and Full-thickness coronally-advanced tunnel (Aroca et al. 2010)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jan 2023to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Universidad Complutense de Madrid
Taranto, 74123
Mario Romandini, mario.romandini@gmail.com
About this study
Official title: 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).
Read the 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.
- Conditions
- Gingival Recession
- Being tested
- Split-thickness non-advanced tunnel (Zabalegui et al. 1999), Full-thickness coronally-advanced tunnel (Aroca et al. 2010)
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split-thickness non-advanced tunnel (Zabalegui et al. 1999)Procedure or surgery
A split-thickness non-advanced tunnel will be performed according to Zabalegui et al. (1999).
Full-thickness coronally-advanced tunnel (Aroca et al. 2010)Procedure or surgery
A full-thickness coronally-advanced tunnel (Modified Coronally Advanced Tunnel - MCAT) will be performed according to Aroca et al. (2010).
| Study group | Role | What they receive |
|---|---|---|
| Split-thickness non-advanced tunnel (Zabalegui et al. 1999) | Experimental | Not described Receives: Procedure: Split-thickness non-advanced tunnel (Zabalegui et al. 1999) |
| Full-thickness coronally-advanced tunnel (Aroca et al. 2010) | Active comparator | Modified Coronally Advanced Tunnel (MCAT) Receives: Procedure: Full-thickness coronally-advanced tunnel (Aroca et al. 2010) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after surgery
Secondary outcomes (15)
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 3 and 6 months after surgery
Root-coverage Esthetic Score (RES)
Evaluated at 3- and 6-months according to Cairo et al. (2009).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 3 and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start5 Jan 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Osteology Foundation
- Responsible party
- Principal investigator, Mario Romandini, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655247
- Sponsor's protocol ID
- MR_03
- Acronym
- Tun_RCT
- Status last verified
- May 2023
- First submitted
- 29 Nov 2022
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 19968743Zabalegui 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.
PubMed 10635186
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial-thickness/Non-advanced vs. Full-thickness/MCAT Tunnelling for the Treatment of Multiple Gingival Recessions: a Multi-centre Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05655247
- Acronym / sponsor ID
- Tun_RCT / MR_03
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Osteology Foundation
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Split-thickness non-advanced tunnel (Zabalegui et al. 1999) | Experimental | Procedure: Split-thickness non-advanced tunnel (Zabalegui et al. 1999) |
| Full-thickness coronally-advanced tunnel (Aroca et al. 2010) | Active comparator | Procedure: Full-thickness coronally-advanced tunnel (Aroca et al. 2010)Modified Coronally Advanced Tunnel (MCAT) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Split-thickness non-advanced tunnel (Zabalegui et al. 1999) |
| 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). | Procedure or surgery | Full-thickness coronally-advanced tunnel (Aroca et al. 2010) |
Primary outcome
Mean Root Coverage (MRC) (6 months)
Time frame: 6 months after surgery
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.
15 secondary outcomes
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
Digital Contact-point/Papilla-tip (dDCP) distance changes
Time frame: 3 and 6 months after surgery
Digital Gingival thickness (dGT)
Time frame: 3 and 6 months after surgery
Digital Keratinized Tissue Height (dKTH) changes
Time frame: 3 and 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 19968743Aroca 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.
- Background: PubMed 10635186Zabalegui 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Split-thickness non-advanced tunnel (Zabalegui et al. 1999) and Full-thickness coronally-advanced tunnel (Aroca et al. 2010) in people with Gingival Recession, run by Universidad Complutense de Madrid at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Romandini (+393801563046, mario.romandini@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Root Coverage (MRC) (6 months) (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05655247, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.