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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

October 30, 2017
November 17, 2017
November 20, 2017
March 1, 2017
March 30, 2019   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT03344315 on ClinicalTrials.gov Archive Site
  • 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 .
  • 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.
  • 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
  • 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
  • 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
  • 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.
  • Aesthetic results [ Time Frame: 12 months ]
    The same blinded investigator will measured the aesthetic result by using the root coverage esthetic score system (RES)
  • 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)
Same as current
Not Provided
Not Provided
 
Xenogeneic Collagen Matrix or Palatal Connective Tissue Graft With a Coronally Advanced Flap in Class III Recessions
Xenogeneic Collagen Matrix or Palatal Connective Tissue Graft With a Coronally Advanced Flap for the Treatment of Miller Class III Gingival Recessions

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.

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.

Interventional
Not Applicable
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
Gingival Recession
  • Device: experimental: collagen matrix
    Mucograft collagen matrix combined with coronal advanced flap
  • Other: Active Comparator: autologous connective tissue graft
    Soft tissue harvesting from patient palate with coronal advanced flap
  • Active Comparator: autologous connective tissue graft
    Soft tissue harvesting from patient palate
    Intervention: Other: Active Comparator: autologous connective tissue graft
  • Experimental: collagen matrix
    Mucograft collagen matrix manufactured by Geistlich AG, Switzerland Device: Collagen matrix
    Intervention: Device: experimental: collagen matrix

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
Same as current
March 30, 2019
March 30, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: 18 years to 75 years
18 Years to 75 Years   (Adult, Older Adult)
Yes
Contact: Elena Ruiz de Gopegui 0034649547011 helenruizdegopegui@gmail.com
Spain
 
 
NCT03344315
2017_02
Yes
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
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://
Elena Ruiz de Gopegui Palacios, Basque Country University
Elena Ruiz de Gopegui Palacios
Geistlich Pharma AG
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
Basque Country University
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP