Clinical and Histomorphometric Analysis of Collagen Matrix Versus Connective Tissue Graft in Mucogingival Surgery in Orthodontic Patients

July 21, 2019 updated by: Elena Ruiz de Gopegui Palacios

Clinical and Histomorphometric Analysis of Collagen Matrix Versus Connective Tissue Graft in Mucogingival Surgery in Orthodontic Patients. A Randomized, Controlled Clinical Trial

There are some orthodontics treatments that perform risk movements ,and a bone dehiscence may be expected. In that cases mucogingival surgery , such as connective tissue grafts, is necessary prior to tooth movement.

The connective tissue graft in combination with coronal advanced flap is still considered the gold standard , although the use of porcine collagen matrix has obtained promising results for treatment of Miller class I and II recession defects.

Most of the studies report clinical results after a connective tissue graft and there is no evidence about the type of attachment obtained after the graft is performed, a few articles have shown histological results. But, as a rule , a histological study is only performed under exceptional circumstances such as a dental fracture, untreatable decay, tooth extraction for orthodontic reasons, or other reasons.

Most of the techniques results in the formation of a long junctional epithelium and connective tissue attachment with fibers parallel to the root surface. Animals studies have shown a shorter epithelium and a larger new cementum formation after the use of the collagen matrix.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to confirm that periodontal regeneration happens after mucogingival surgery The principal outcome is compare the millimeters of new attachment create after a connective tissue graft and after the use of a porcine collagen matrix in teeth that have to been extracted (because of the orthodontic planing treatment) after mucogingival surgery .

The secondary outcomes are:

  1. length of new cementum (histometry results)
  2. length of the junctional epithelium (histometry results)
  3. length of connective tissue attachment (histometry results)
  4. complete root coverage (clinical results)
  5. width of keratinized tissue

Study Type

Interventional

Enrollment (Anticipated)

5

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 Contact

Study Contact Backup

Study Locations

  • Spain
    • Biscay
      • Leioa, Biscay, Spain, 48940
        • Recruiting
        • Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elena Ruiz de Gopegui Palacios
        • Principal Investigator:
          • Ana Maria Garcia de la Fuente
        • Principal Investigator:
          • Luis Antonio Aguirre Zorzano
        • Sub-Investigator:
          • Ruth Estefanía Fresco
        • Sub-Investigator:
          • Xavier Marichalar Mendia
        • Sub-Investigator:
          • Jose Manuel Aguirre Urizar

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:

  • Patient in orthodontic treatment ,who needs mucogingival surgery in both hemi arcade and later the tooth adjacent to the graft should be extracted because of the orthodontic planing treatment .
  • The patient must be 18 years or older
  • Patient shows sufficient plaque control (FMPS < 20%).
  • 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 Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
millimeters of new attachment
Time Frame: Change from baseline at following surgery sixth month
histometry assessment
Change from baseline at following surgery sixth month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of new cementum
Time Frame: Change from baseline at following surgery sixth month
histometry assessment
Change from baseline at following surgery sixth month
Length of new junctional epithelium
Time Frame: Change from baseline at following surgery sixth month
histometry assessment
Change from baseline at following surgery sixth month
length of connective attachment
Time Frame: Change from baseline at following surgery sixth month
histometry assessment
Change from baseline at following surgery sixth month
complete root coverage
Time Frame: Change from baseline at following surgery sixth month
clinical assessment
Change from baseline at following surgery sixth month
width of keratinized tissue
Time Frame: Change from baseline at following surgery sixth month
clinical assessment
Change from baseline at following surgery sixth month

Collaborators and Investigators

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

Sponsor

Elena Ruiz de Gopegui Palacios

Investigators

  • Study Director: Luis Antonio Aguirre Zorzano, University of the Basque Country (UPV/EHU)
  • Principal Investigator: Elena Ruiz de Gopegui, University of the Basque Country (UPV/EHU)
  • Principal Investigator: Ana Maria Garcia de la Fuente, University of the Basque Country (UPV/EHU)
  • Study Chair: Jose Manuel Aguirre Urizar, 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)

September 1, 2018

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

May 10, 2018

First Submitted That Met QC Criteria

May 21, 2018

First Posted (Actual)

May 23, 2018

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 21, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCP-2

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

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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