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NCT Number: NCT03344315

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

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Leioa, Biscay, 48940, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

experimental: collagen matrix

Device

Mucograft collagen matrix combined with coronal advanced flap

Active Comparator: autologous connective tissue graft

Other

Soft tissue harvesting from patient palate with coronal advanced flap

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of the Basque Country (UPV/EHU)

Other

Collaborators

  • Geistlich Pharma AG

Registry information

Official study title

Xenogeneic Collagen Matrix or Palatal Connective Tissue Graft With a Coronally Advanced Flap for the Treatment of Miller Class III Gingival Recessions

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2017
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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