Gingival RecessionsNCT03258996

m-VISTA Technique vs. CAF in the Treatment of Class III Multiple Recessions

A study testing Modified vestibular incision subperiosteal tunnel access and Coronally advanced flap in people with Gingival Recessions, run by Aitziber Fernandez Jimenez at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The main objective is to assess whether the percentage of root coverage (%RC) achieved in the treatment of multiples class III recessions using the technique we have called modified vestibular incision subperiosteal tunnel access (m-VISTA), which is a lateral approach subperiosteal tunnel technique, combined with a… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Gingival Recessions
What is being tested?: Modified vestibular incision subperiosteal tunnel access and Coronally advanced flap
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteSpain
Study dates: 4 Dec 2017to 30 Sep 2021
Phase: Interventional
Are there results?: None posted in the registry

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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients of the Master of Periodontology of the UPV / EHU.
Age ≥ 18 years.
Multiple recessions (more than two) Class III ≥ 2 mm deep, in which the interdental papilla does not extend beyond the cementoenamel line.
Absence of active periodontal disease.
Plaque index (O'Leary et al. 1972) and bleeding index (Ainamo and Bay 1975) ≤15%.
Informed consent.

Who cannot join

Smokers > 10 cigarettes / day.
Subjects with systemic conditions that contraindicate surgery.
Subjects that have taken analgesics and anti-inflammatory drugs in the last 72 hours.
Subjects taking opioids, anticonvulsants and antidepressants except serotonin selective inhibitors.
Women who are pregnant or nursing.
Patients who do not wish to participate in the study.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country
Leioa, Biscay, 48940

Other trials in Spain

About this study

Official title: Modified VISTA Technique Versus Coronally Advanced Flap in the Treatment of Class III Multiple Recessions: Randomized Clinical Trial

Read the detailed description

The reason for designing this study is that treatment of Class III gingival recessions (Miller 1985) continues to be challenging today and, although different techniques have been proposed to attempt to improve root coverage results, there is little evidence on what would offer better results.

To achieve those objectives a randomized controlled clinical trial is designed. Using the percentage of root coverage as a primary response variable, it is estimated with the calculation of the sample size, we would need 11 patients for each treatment group (Domenech and Granero 2010). In addition, taking into account possible drop-outs, we would increase the number of patients by recruiting a total of 24 patients.

A same experienced, blind and calibrated (the intraclass correlation coefficient will be at least of 0.75) examiner (R.E.) will collect the following periodontal clinical parameters at the baseline, and at 6 and 12 months, in each tooth involved, using a periodontal probe: Gingival recession, number and location of recessions to be treated, number of treated recessions that have a complete root coverage, the width of the gingival recession and the keratinized gingiva, the distance from the contact point to the interdental papilla, depth of probing, bleeding index and plaque index. And will also collect the opinion of the participant regarding pain and the degree of satisfaction with the aesthetic result.

Students of the University of the Basque Country's (UPV/EHU) Own Degree in Periodontology and Osteointegration will perform the corresponding surgical technique (m-VISTA or CAF) depending on the randomization sequence obtained. A clinical monitor (A.M.G.) will keep the sequence hidden until the moment of the intervention.

Initially, the subject will not know which technique to receive, the complete information regarding the surgical technique used, as the results obtained in his case, will be given in the last visit of the year.

Finally, a blind statistic (X.M) will analyze the data using the SPSS software, having as unit of analysis the subject. Doing a descriptive statistics, checking if the groups are homogeneous in basal, inter-group, intra-group and change variables comparisons and logistical regression to assess the intensity and duration of post-surgical pain adjusted for possible confounding factors.

Conditions: Gingival Recessions
Being tested: Modified vestibular incision subperiosteal tunnel access, Coronally advanced flap
Keywords: Gingival recession, Class III gingival recession, Multiples gingival recessions, Periodontitis, Mucogingival surgery, Modified vestibular incision subperiosteal tunnel access, Coronally advanced flap, Connective tissue graft, Post-surgical pain
Medical subject headings: Gingival Recession, Periodontitis, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Modified vestibular incision subperiosteal tunnel accessProcedure or surgery
Also called m-VISTA
Single vertical mucosal incision, in the middel of the area to be treated, from which we began to lift a mucoperiosteal flap in a single plane.
With a micro-scalpel intrasulcular incisions are made extending to the base of the papillas.
Preparation of a tunnel in the same plane. Take a connective tissue graft on the same side of the palate. The connective graft is inserted through the vertical incision prepared with the aid of the suture.
All is stabilized by means of suspensory sutures of coronal traction on each point of contact.
Finally the vertical incision made is sutured.
Coronally advanced flapProcedure or surgery
Also called CAF
Oblique submarginal incisions in both interdental areas of each recession, which continue with the intrasulcular incision, one tooth extending on each side of the teeth to be treated.
A partial-total-partial thickness flap is elevated in the coronal-apical direction.
A vestibular mucosal dissection is performed to eliminate muscle tension. The remnant tissue of the anatomical interdental papillas is desepithelized. Take a CTG on the same side of the palate. The connective tissue graft is stabilized with resorbable suture over the recessions with suspensory sutures on the teeth.
Finally, suspensory sutures with non-resorbable sutures are also used to achieve an accurate adaptation of the vestibular flap over the exposed root and stabilize each surgical papilla over each desepithelized interdental area.

Study groups in NCT03258996
Study group	Role	What they receive
Modified vestibular incision subperiosteal tunnel access	Experimental	Test group: Coverage of Class III multiples gingival recessions with the application of Modified vestibular incision subperiosteal tunnel access technique and a connective tissue graft from the palate. Receives: Procedure: Modified vestibular incision subperiosteal tunnel access
Coronally advanced flap	Active comparator	Control group: Coverage of Class III multiples gingival recessions with the application of Coronally advanced flap and a connective tissue graft from the palate. Receives: Procedure: Coronally advanced flap

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of root coverage (%CR)
In each patient the mean of their gingival recessions at baseline (initial RECm) and at 12 months (RECm_12 months) will be calculated. A new variable called %CR [(RECm_initial - RECm_12 months) / (RECm_initial x 100) will be calculated.
Measured: 12 months

Secondary outcomes (15)

Percentage of recessions with complete root coverage (%CRC)
Each patient will record the number of recessions, which after treatment, show complete root coverage at 12 months (CRC_12 months). A new variable called % CRC_12 months [CRC_12meses / NRT x100] will be calculated.
Measured: 12 months
Post-surgical pain perception
The subject will we instructed to collect their perception of post-surgical pain in the VAS based Journal of Pain (IDT). Specifically the subject will record: Its intensity (0-100mm), its duration (minutes or hours) and if any analgesic treatment has been necessary (No o Yes: Which?).
Measured: After surgery up to 14 days
Gingival recession (REC)
Distance in mm from the amelocementaria line the gingival margin, measured at the vestibular midpoint. It will be registered in all the teeth present (except wisdom teeth) at the beginning, and, during the follow-up only in the recessions to be treated.
Measured: Change from baseline at following surgery sixth and twelfth month respectively.
Post-surgical aesthetic result (VAS aesthetic)
The same examiner will evaluate the degree of satisfaction of the subject with the aesthetic result obtained after the intervention, through a Questionnaire based on the Visual Analogue Scale (VAS).
Measured: 12 months
Pre-surgical pain perception
In the VAS based Journal of Pain (IDT) the examiner will record if the subject has had regional head and neck pain in the last month and if there is any pain in the immediate preoperative, if it is affirmative the intensity will be noted.
Measured: Baseline.
Post-surgical complications
The presence or not, as the description, of the post-surgical complications (PSC) that may appear will be collected.
Measured: After surgery first seven days.
Central Sensitization Inventory severity-level score of the subject
Central Sensitization inventory (CSI) (Mayer et al. 2012) will be done, in which each subject will be asked on the frequency in which he perceives 25 symptoms and will be given a score of 0-4 finally establishing a clinical level in a range of 0-100 points (Subclinical: 0-29; Medium: 30-39; Moderate: 40-49 ; Severe: 50-59; Extreme: 60-100).
Measured: Baseline.
Number of recessions to be treated (NRT) Number of recessions to be treated (NRT)
Number of Class III recessions to be treated will be recorded.
Measured: Baseline.
Localization of the recessions to treat (LRT)
On the one hand, upper recessions will be considered the located in the maxillary and on the other hand, lower recessions those located in the mandible.
Measured: Baseline.
Gingival recession width (GRW)
Mesio-distal distance taken in the coronal area of the same, measured in millimeters. It will be recorded only in the recessions to be treated.
Measured: Change from baseline at following surgery sixth and twelfth month respectively.
Keratinized gingiva width (KGW)
Distance in millimeters from the mucogingival junction to the gingival margin, measured at the vestibular midpoint. It will be recorded only in the recessions to be treated.
Measured: Change from baseline at following surgery sixth and twelfth month respectively.
Distance from contact point to the interdental papilla (CP-IP)
Distance in millimeters from the mesial and distal contact point of the tooth with recession, to the most coronal part of the interdental papilla. It will be recorded only in the recessions to be treated.
Measured: Change from baseline at following surgery sixth and twelfth month respectively.
Probing depth (PD)
Distance in millimeters from the gingival margin to the bottom of the periodontal pocket. It will be recorded at the beginning in all teeth present (except wisdow teeth) in 6 points per tooth (mesio-bucal, mid-bucal, disto-bucal, mesio-lingual, mid-lingual and disto-lingual) and, during follow-up, only in the recessions to be treated at the vestibular mid-point.
Measured: Change from baseline at following surgery sixth and twelfth month respectively.
Patient bleeding index (BI)
After a periodontal probing of all teeth, the presence (yes or no) of bleeding is recorded dichotomously at 6 points per tooth (mesio-bucal, mid-bucal, disto-bucal, mesio-lingual, mid-lingual and disto-lingual) and the percentage of sites that bleed from the total of probed sites is calculated (Ainamo and Bay 1975).
Measured: Change from baseline at following surgery sixth and twelfth month respectively.
Patient plaque index (PI)
A plaque developer is used and the presence (yes or no) of plaque is recorded dichotomously at 6 points per tooth (mesio-bucal, mid-bucal, disto-bucal, mesio-lingual, mid-lingual and disto-lingual) and the percentage of sites with plaque of the total probed sites is calculated (O'Leary et al 1972).
Measured: Change from baseline at following surgery sixth and twelfth month respectively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 201730 Sep 2021

First posted23 Aug 2017
Study start4 Dec 2017
Primary completion31 Mar 2021
Study completion30 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Gingival RecessionsStudies 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
Model description: We will perform the experimental or control technique according to the randomization sequence.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03258996
Sponsor's protocol ID: 2017_01
Status last verified: Mar 2022
First submitted: 18 Aug 2017
Last updated: 8 Mar 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The data collected for the study will be identified by a code and only the researcher will be able to relate them. The personal data will be treated with absolute confidentiality in accordance with the Data Protection Law and will remain in the patient's clinical history. The coded data will be included in a UPV/EHU´s file with reference number 2080310015-INA0110, whose head is Ana María García de la Fuente, and will only be used for the purposes of this project.

Publications

Agudio G, Nieri M, Rotundo R, Franceschi D, Cortellini P, Pini Prato GP. Periodontal conditions of sites treated with gingival-augmentation surgery compared to untreated contralateral homologous sites: a 10- to 27-year long-term study. J Periodontol. 2009 Sep;80(9):1399-405. doi: 10.1902/jop.2009.090122.
PubMed 19722789
Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
PubMed 1058834
Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. doi: 10.1902/annals.1999.4.1.1.
PubMed 10863370
Aroca S, Keglevich T, Barbieri B, Gera I, Etienne D. Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study. J Periodontol. 2009 Feb;80(2):244-52. doi: 10.1902/jop.2009.080253.
PubMed 19186964
Aroca S, Molnar B, Windisch P, Gera I, Salvi GE, Nikolidakis D, Sculean A. Treatment of multiple adjacent Miller class I and II gingival recessions with a Modified Coronally Advanced Tunnel (MCAT) technique and a collagen matrix or palatal connective tissue graft: a randomized, controlled clinical trial. J Clin Periodontol. 2013 Jul;40(7):713-20. doi: 10.1111/jcpe.12112. Epub 2013 Apr 30.
PubMed 23627374
Butler BL. The subepithelial connective tissue graft with a vestibular releasing incision. J Periodontol. 2003 Jun;74(6):893-8. doi: 10.1902/jop.2003.74.6.893.
PubMed 12887003
Carvalho PF, da Silva RC, Cury PR, Joly JC. Modified coronally advanced flap associated with a subepithelial connective tissue graft for the treatment of adjacent multiple gingival recessions. J Periodontol. 2006 Nov;77(11):1901-6. doi: 10.1902/jop.2006.050450.
PubMed 17076617
Chatterjee A, Sharma E, Gundanavar G, Subbaiah SK. Treatment of multiple gingival recessions with vista technique: A case series. J Indian Soc Periodontol. 2015 Mar-Apr;19(2):232-5. doi: 10.4103/0972-124X.145836.
PubMed 26015680
Daprile G, Gatto MR, Checchi L. The evolution of buccal gingival recessions in a student population: a 5-year follow-up. J Periodontol. 2007 Apr;78(4):611-4. doi: 10.1902/jop.2007.060277.
PubMed 17397306
de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. doi: 10.1111/j.1600-051X.2006.01039.x.
PubMed 17309597
Del Corso M, Sammartino G, Dohan Ehrenfest DM. Re: "Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study". J Periodontol. 2009 Nov;80(11):1694-7; author reply 1697-9. doi: 10.1902/jop.2009.090253.
PubMed 19905939
Kennedy JE, Bird WC, Palcanis KG, Dorfman HS. A longitudinal evaluation of varying widths of attached gingiva. J Clin Periodontol. 1985 Sep;12(8):667-75. doi: 10.1111/j.1600-051x.1985.tb00938.x.
PubMed 3902907
Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27.
PubMed 21951710
Miller PD Jr. A classification of marginal tissue recession. Int J Periodontics Restorative Dent. 1985;5(2):8-13. No abstract available.
PubMed 3858267
Molnar B, Aroca S, Keglevich T, Gera I, Windisch P, Stavropoulos A, Sculean A. Treatment of multiple adjacent Miller Class I and II gingival recessions with collagen matrix and the modified coronally advanced tunnel technique. Quintessence Int. 2013 Jan;44(1):17-24. doi: 10.3290/j.qi.a28739.
PubMed 23444157

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gingival Recessions trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Modified VISTA Technique Versus Coronally Advanced Flap in the Treatment of Class III Multiple Recessions: Randomized Clinical Trial
ClinicalTrials.gov ID: NCT03258996
Acronym / sponsor ID: 2017_01
Conditions: Gingival Recessions
Keywords: Gingival recession, Class III gingival recession, Multiples gingival recessions, Periodontitis, Mucogingival surgery, Modified vestibular incision subperiosteal tunnel access, Coronally advanced flap, Connective tissue graft
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Aitziber Fernandez JimenezUniversity, hospital or other
Study start: 4 Dec 2017 (actual)
Primary completion: 31 Mar 2021 (actual)
Study completion: 30 Sep 2021 (actual)
First posted: 23 Aug 2017 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: We will perform the experimental or control technique according to the randomization sequence.

Arm	Type	Receives
Modified vestibular incision subperiosteal tunnel access	Experimental	Procedure: Modified vestibular incision subperiosteal tunnel accessTest group: Coverage of Class III multiples gingival recessions with the application of Modified vestibular incision subperiosteal tunnel access technique and a connective tissue graft from the palate.
Coronally advanced flap	Active comparator	Procedure: Coronally advanced flapControl group: Coverage of Class III multiples gingival recessions with the application of Coronally advanced flap and a connective tissue graft from the palate.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients of the Master of Periodontology of the UPV / EHU.
Age ≥ 18 years.
Multiple recessions (more than two) Class III ≥ 2 mm deep, in which the interdental papilla does not extend beyond the cementoenamel line.
Absence of active periodontal disease.
Plaque index (O'Leary et al. 1972) and bleeding index (Ainamo and Bay 1975) ≤15%.

Key exclusion criteria (6 listed)

Smokers > 10 cigarettes / day.
Subjects with systemic conditions that contraindicate surgery.
Subjects that have taken analgesics and anti-inflammatory drugs in the last 72 hours.
Subjects taking opioids, anticonvulsants and antidepressants except serotonin selective inhibitors.
Women who are pregnant or nursing.

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
Modified vestibular incision subperiosteal tunnel accessAlso: m-VISTASingle vertical mucosal incision, in the middel of the area to be treated, from which we began to lift a mucoperiosteal flap in a single plane. With a micro-scalpel intrasulcular incisions are made extending to the base of the papillas. Preparation of a tunnel in the same plane. Take a connective tissue graft on the same side of the palate. The connective graft is inserted through the vertical incision prepared with the aid of the suture. All is stabilized by means of suspensory sutures of coronal traction on each point of contact. Finally the vertical incision made is sutured.	Procedure or surgery	Modified vestibular incision subperiosteal tunnel access
Coronally advanced flapAlso: CAFOblique submarginal incisions in both interdental areas of each recession, which continue with the intrasulcular incision, one tooth extending on each side of the teeth to be treated. A partial-total-partial thickness flap is elevated in the coronal-apical direction. A vestibular mucosal dissection is performed to eliminate muscle tension. The remnant tissue of the anatomical interdental papillas is desepithelized. Take a CTG on the same side of the palate. The connective tissue graft is stabilized with resorbable suture over the recessions with suspensory sutures on the teeth. Finally, suspensory sutures with non-resorbable sutures are also used to achieve an accurate adaptation of the vestibular flap over the exposed root and stabilize each surgical papilla over each desepithelized interdental area.	Procedure or surgery	Coronally advanced flap

Primary outcome

Percentage of root coverage (%CR)
Time frame: 12 months
In each patient the mean of their gingival recessions at baseline (initial RECm) and at 12 months (RECm_12 months) will be calculated. A new variable called %CR [(RECm_initial - RECm_12 months) / (RECm_initial x 100) will be calculated.

15 secondary outcomes

Percentage of recessions with complete root coverage (%CRC)
Time frame: 12 months
Post-surgical pain perception
Time frame: After surgery up to 14 days
Gingival recession (REC)
Time frame: Change from baseline at following surgery sixth and twelfth month respectively.
Post-surgical aesthetic result (VAS aesthetic)
Time frame: 12 months
Pre-surgical pain perception
Time frame: Baseline.
Post-surgical complications
Time frame: After surgery first seven days.
Central Sensitization Inventory severity-level score of the subject
Time frame: Baseline.
Number of recessions to be treated (NRT) Number of recessions to be treated (NRT)
Time frame: Baseline.
Localization of the recessions to treat (LRT)
Time frame: Baseline.
Gingival recession width (GRW)
Time frame: Change from baseline at following surgery sixth and twelfth month respectively.
Keratinized gingiva width (KGW)
Time frame: Change from baseline at following surgery sixth and twelfth month respectively.
Distance from contact point to the interdental papilla (CP-IP)
Time frame: Change from baseline at following surgery sixth and twelfth month respectively.
Probing depth (PD)
Time frame: Change from baseline at following surgery sixth and twelfth month respectively.
Patient bleeding index (BI)
Time frame: Change from baseline at following surgery sixth and twelfth month respectively.
Patient plaque index (PI)
Time frame: Change from baseline at following surgery sixth and twelfth month respectively.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
Background: PubMed 19722789Agudio G, Nieri M, Rotundo R, Franceschi D, Cortellini P, Pini Prato GP. Periodontal conditions of sites treated with gingival-augmentation surgery compared to untreated contralateral homologous sites: a 10- to 27-year long-term study. J Periodontol. 2009 Sep;80(9):1399-405. doi: 10.1902/jop.2009.090122.
Background: PubMed 1058834Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
Background: PubMed 10863370Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. doi: 10.1902/annals.1999.4.1.1.
Background: PubMed 19186964Aroca S, Keglevich T, Barbieri B, Gera I, Etienne D. Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study. J Periodontol. 2009 Feb;80(2):244-52. doi: 10.1902/jop.2009.080253.
Background: PubMed 23627374Aroca S, Molnar B, Windisch P, Gera I, Salvi GE, Nikolidakis D, Sculean A. Treatment of multiple adjacent Miller class I and II gingival recessions with a Modified Coronally Advanced Tunnel (MCAT) technique and a collagen matrix or palatal connective tissue graft: a randomized, controlled clinical trial. J Clin Periodontol. 2013 Jul;40(7):713-20. doi: 10.1111/jcpe.12112. Epub 2013 Apr 30.
Background: PubMed 12887003Butler BL. The subepithelial connective tissue graft with a vestibular releasing incision. J Periodontol. 2003 Jun;74(6):893-8. doi: 10.1902/jop.2003.74.6.893.
Background: PubMed 17076617Carvalho PF, da Silva RC, Cury PR, Joly JC. Modified coronally advanced flap associated with a subepithelial connective tissue graft for the treatment of adjacent multiple gingival recessions. J Periodontol. 2006 Nov;77(11):1901-6. doi: 10.1902/jop.2006.050450.
Background: PubMed 26015680Chatterjee A, Sharma E, Gundanavar G, Subbaiah SK. Treatment of multiple gingival recessions with vista technique: A case series. J Indian Soc Periodontol. 2015 Mar-Apr;19(2):232-5. doi: 10.4103/0972-124X.145836.
Background: PubMed 17397306Daprile G, Gatto MR, Checchi L. The evolution of buccal gingival recessions in a student population: a 5-year follow-up. J Periodontol. 2007 Apr;78(4):611-4. doi: 10.1902/jop.2007.060277.
Background: PubMed 17309597de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. doi: 10.1111/j.1600-051X.2006.01039.x.
Background: PubMed 19905939Del Corso M, Sammartino G, Dohan Ehrenfest DM. Re: "Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study". J Periodontol. 2009 Nov;80(11):1694-7; author reply 1697-9. doi: 10.1902/jop.2009.090253.
Background: PubMed 3902907Kennedy JE, Bird WC, Palcanis KG, Dorfman HS. A longitudinal evaluation of varying widths of attached gingiva. J Clin Periodontol. 1985 Sep;12(8):667-75. doi: 10.1111/j.1600-051x.1985.tb00938.x.
Individual participant dataSharing planned: Yes. The data collected for the study will be identified by a code and only the researcher will be able to relate them. The personal data will be treated with absolute confidentiality in accordance with the Data Protection Law and will remain in the patient's clinical history. The coded data will be included in a UPV/EHU´s file with reference number 2080310015-INA0110, whose head is Ana María García de la Fuente, and will only be used for the purposes of this project.

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Gingival Recession

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. This study is not recruiting at the moment.

Luis Antonio Aguirre Zorzano, Dr. study director

University of the Basque Country (UPV/EHU)

Aitziber Fernández Jiménez, Lcda. principal investigator

University of the Basque Country (UPV/EHU)

Ruth Estefanía Fresco, Dr. study chair

University of the Basque Country (UPV/EHU)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Modified vestibular incision subperiosteal tunnel access and Coronally advanced flap in people with Gingival Recessions, run by Aitziber Fernandez Jimenez at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2022. 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 Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of root coverage (%CR) (time frame: 12 months). 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 NCT03258996, which also lists 28 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 8 Mar 2022.