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Xenogeneic Collagen Matrix or Palatal Connective Tissue Graft With a Coronally Advanced Flap in Class III Recessions

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ClinicalTrials.gov Identifier: NCT03344315
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 20, 2017
Sponsor:
Collaborator:
Geistlich Pharma AG
Information provided by (Responsible Party):
Elena Ruiz de Gopegui Palacios, Basque Country University

Brief Summary:

The purpose of this multi-center study is to compare the effectiveness of Mucograft versus connective tissue graft in combination with coronal advanced flap for the treatment of Miller class III recessions The connective tissue graft in combination with coronal advanced flap is considered the gold standard for the treatment of gingival recession in terms of percentage of root coverage and complete root coverage. However connective tissue graft harvesting from the palatal mucosa is often associated with increased patient morbidity, prolonged surgical time and is limited supply. To overcome these inconvenients many efforts are made to develop new materials (healing modifiers, barrier membranes and grafts substitutes) Recently a new two-layer , xenogenic collagen matrix (Mucograft: Geistlich Pharma , Wolhusen Switzerland) has been proposed for regenerative therapy involving teeth and implants. The use of this porcine collagen matrix has obtained promising results for treatment of Miller class I and II recession defects (isolated and multiple recession defects) The mayority of root coverage studies in the literature treats Miller class I and II recession defects .Surgical treatment of class III recesión defects is more challenging due to loss of interproximal bone and soft tissues and complete root coverage may not be expected . But some recent studies demonstrate complete root coverage and high percentage of root coverage in class III recessions. Also a new classification system using the level of interproximal attachment level has been proposed to predict the final root coverage outcome.

So ,the soft tissue substitutes should be used also in Miller class III recession, and because of that fact, the investigators are conducting this study, to evaluate the effectiveness of Mucograft in Miller class III recessions compared with connective tissue graft.


Condition or disease Intervention/treatment
Gingival Recession Device: experimental: collagen matrix Other: Active Comparator: autologous connective tissue graft

Detailed Description:

Given data reported by the study of Aroca in 2013 ,using the percentage of root coverage as a primary response variable the sample size was estimated in 20 patients. In addition, taking into account possible drop-outs, the investigators would increase the number of patients by 20%, finally recruiting 24 patients per group.

Randomization was performed by computer generated random codes Study locations will include two private centers in Spain. A single calibrated examiner, blind with respect to the treatment assignment, will perform all measurements at all center.

A biostatistician blind with respect to treatment assignment will perform the analysis.

Interventions and Duration The two intervention groups will consist of surgery with connective tissue graft (standard of care control) and surgery with the application of Mucograft Collagen Matrix (MCM, Test group). Experienced clinicians will deliver treatment consisting of root coverage surgery using coronally advanced flaps, the most utilized procedure for coverage of recessions. Surgery will be standardized and the same procedures/materials will be employed to ensure consistency.

Follow-up of individual patients will be 12 months.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: split mouth
Masking: Single (Outcomes Assessor)
Masking Description:

Observer: Another periodoncist outside the intervention, would be in charge of recording the clinical parameters.

Analyst: The statistician does not know which treatment corresponds to each variable.

Primary Purpose: Treatment
Official Title: Xenogeneic Collagen Matrix or Palatal Connective Tissue Graft With a Coronally Advanced Flap for the Treatment of Miller Class III Gingival Recessions
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : March 30, 2019

Arm Intervention/treatment
Active Comparator: autologous connective tissue graft
Soft tissue harvesting from patient palate
Other: Active Comparator: autologous connective tissue graft
Soft tissue harvesting from patient palate with coronal advanced flap
Experimental: collagen matrix
Mucograft collagen matrix manufactured by Geistlich AG, Switzerland Device: Collagen matrix
Device: experimental: collagen matrix
Mucograft collagen matrix combined with coronal advanced flap



Primary Outcome Measures :
  1. Percentage of root coverage [ Time Frame: Change from baseline at following surgery sixth and twelfth month respectively ]
    In each patient the mean of their gingival recessions at baseline (initial RECm)and at 6 (RECm 6months)and 12 months (RECm 12 months) will be calculated measuring at the mid buccal point of the involved teeth by the same blinded investigator using the same periodontal probe (PCP SE-11 Hu Friedly, Chicago, IL USA). With this measurements the percentage of root coverage will be calculated


Secondary Outcome Measures :
  1. Percentage of recessions with Complete root coverage [ Time Frame: Change from baseline at following surgery sixth and twelfth month respectively ]
    The number of recessions which after the treatment show complete root coverage (no recession) measured at the mid buccal point of the involved teeth at baseline and at 6 and 12 months .

  2. Patient centred outcomes [ Time Frame: after surgery up to 7 days and 1 year ]
    At suture removal both procedures will be evaluated by the patient for discomfort, duration and difficulty on a visual analogue scale (VAS) . At 12 months the aesthetic outcome obtained with both treatment modalities will be appreciated by the patient on a VAS scale.

  3. Gingival Thickness [ Time Frame: Change from baseline at following surgery and twelfth month respectively ]
    The thickness in millimeters measured 3mm apically from the free gingival margin at the mid buccal aspect of the tooth

  4. Keratinized Tissue width [ Time Frame: Change from baseline at following surgery sixth and twelfth month respectively ]
    Distance from the mucogingival junction to the gingival margin

  5. Clinical Attachment Level [ Time Frame: Change from baseline at following surgery sixth and twelfth month respectively ]
    The gain of clinical attachment level in milimetres, compared with baseline

  6. Recession width [ Time Frame: Change from baseline at following surgery sixth and twelfth month respectively ]
    Mesio-distal distance taken in the coronal area of the same, measured in millimeters.

  7. Aesthetic results [ Time Frame: 12 months ]
    The same blinded investigator will measured the aesthetic result by using the root coverage esthetic score system (RES)

  8. Time of surgery [ Time Frame: After surgery up to 7 days ]
    At surgery, the length of time of the full procedure will be evaluated (in minutes)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   18 years to 75 years
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The patient must be 18 years or older
  • Patient with one or more recession defects are Miller Class III in incisives, canines and premolars. In at least two quadrants
  • Patient shows sufficient plaque control (FMPS < 20%).
  • Treated periodontal conditions
  • The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent.

Exclusion Criteria:

  • General contraindications for dental and/or surgical treatment are present.
  • The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs).
  • Untreated periodontal conditions
  • Patients not willing to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03344315


Contacts
Contact: Elena Ruiz de Gopegui 0034649547011 helenruizdegopegui@gmail.com

Locations
Spain
Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country Recruiting
Leioa, Biscay, Spain, 48940
Contact: Elena Ruiz de Gopegui    0034649547011    helenruizdegopegui@gmail.com   
Principal Investigator: Elena Ruiz de Gopegui         
Principal Investigator: Luis Antonio Aguirre Zorzano         
Sub-Investigator: Miren Vilor Fernández         
Sub-Investigator: Ana García de la Fuente         
Sub-Investigator: Ruth Estefanía Fresco         
Sub-Investigator: Xabier Marichalar Mendía         
Sponsors and Collaborators
Elena Ruiz de Gopegui Palacios
Geistlich Pharma AG
Investigators
Principal Investigator: Luis Antonio Aguirre Zorzano Basque Country University
Principal Investigator: Elena Ruiz de Gopegui Palacios Basque Country University
Study Chair: Miren Vilor Fernandez Basque Country University
Study Chair: Ana Garcia de la Fuente Basque Country University
Study Chair: Ruth Estefania Fresco Basque Country University
Study Chair: Xavier Marichalar Mendia Basque Country University

Publications:

Responsible Party: Elena Ruiz de Gopegui Palacios, Principal Investigator, Basque Country University
ClinicalTrials.gov Identifier: NCT03344315     History of Changes
Other Study ID Numbers: 2017_02
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Elena Ruiz de Gopegui Palacios, Basque Country University:
Gingival recession
Collagen matrix
Connective tissue graft
Coronally advanced flap
Root coverage
keratinized tissue
Periodontal disease

Additional relevant MeSH terms:
Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy