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

April 14, 2021 updated by: Elena Ruiz de Gopegui Palacios, University of the Basque Country (UPV/EHU)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline at following surgery sixth and twelfth month respectively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
Change from baseline at following surgery sixth and twelfth month respectively
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.
after surgery up to 7 days and 1 year
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
Change from baseline at following surgery and twelfth month respectively
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
Change from baseline at following surgery sixth and twelfth month respectively
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
Change from baseline at following surgery sixth and twelfth month respectively
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.
Change from baseline at following surgery sixth and twelfth month respectively
Aesthetic results
Time Frame: 12 months
The same blinded investigator will measured the aesthetic result by using the root coverage esthetic score system (RES)
12 months
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)
After surgery up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Basque Country (UPV/EHU)

Collaborators

Geistlich Pharma AG

Investigators

  • Principal Investigator: Luis Antonio Aguirre Zorzano, University of the Basque Country (UPV/EHU)
  • Principal Investigator: Elena Ruiz de Gopegui Palacios, University of the Basque Country (UPV/EHU)
  • Study Chair: Miren Vilor Fernandez, University of the Basque Country (UPV/EHU)
  • Study Chair: Ana Garcia de la Fuente, University of the Basque Country (UPV/EHU)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

October 30, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017_02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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