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

Primary Purpose

Gingival Recession

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Collagen matrix
autologous connective tissue graft
Sponsored by
Elena Ruiz de Gopegui Palacios
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring collagen matrix, connective tissue graft, histometry, xenograft, periodontal regeneration, biometry

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Autologous connective tissue graft

collagen matrix

Arm Description

Soft tissue harvesting from patient palate

Mucograft collagen matrix manufactured by Geistlich AG, Switzerland Device: Collagen matrix

Outcomes

Primary Outcome Measures

millimeters of new attachment
histometry assessment

Secondary Outcome Measures

Length of new cementum
histometry assessment
Length of new junctional epithelium
histometry assessment
length of connective attachment
histometry assessment
complete root coverage
clinical assessment
width of keratinized tissue
clinical assessment

Full Information

First Posted
May 10, 2018
Last Updated
July 21, 2019
Sponsor
Elena Ruiz de Gopegui Palacios
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1. Study Identification

Unique Protocol Identification Number
NCT03533933
Brief Title
Clinical and Histomorphometric Analysis of Collagen Matrix Versus Connective Tissue Graft in Mucogingival Surgery in Orthodontic Patients
Official Title
Clinical and Histomorphometric Analysis of Collagen Matrix Versus Connective Tissue Graft in Mucogingival Surgery in Orthodontic Patients. A Randomized, Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elena Ruiz de Gopegui Palacios

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: length of new cementum (histometry results) length of the junctional epithelium (histometry results) length of connective tissue attachment (histometry results) complete root coverage (clinical results) width of keratinized tissue

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
collagen matrix, connective tissue graft, histometry, xenograft, periodontal regeneration, biometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Split mouth
Masking
Outcomes Assessor
Masking Description
Analyst and Histometry: The statistician and the pathologist does not know which treatment corresponds to each variable.
Allocation
Randomized
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous connective tissue graft
Arm Type
Active Comparator
Arm Description
Soft tissue harvesting from patient palate
Arm Title
collagen matrix
Arm Type
Experimental
Arm Description
Mucograft collagen matrix manufactured by Geistlich AG, Switzerland Device: Collagen matrix
Intervention Type
Device
Intervention Name(s)
Collagen matrix
Intervention Description
Mucograft collagen matrix combined with coronal advanced flap
Intervention Type
Other
Intervention Name(s)
autologous connective tissue graft
Intervention Description
Soft tissue harvesting from patient palate with coronal advanced flap
Primary Outcome Measure Information:
Title
millimeters of new attachment
Description
histometry assessment
Time Frame
Change from baseline at following surgery sixth month
Secondary Outcome Measure Information:
Title
Length of new cementum
Description
histometry assessment
Time Frame
Change from baseline at following surgery sixth month
Title
Length of new junctional epithelium
Description
histometry assessment
Time Frame
Change from baseline at following surgery sixth month
Title
length of connective attachment
Description
histometry assessment
Time Frame
Change from baseline at following surgery sixth month
Title
complete root coverage
Description
clinical assessment
Time Frame
Change from baseline at following surgery sixth month
Title
width of keratinized tissue
Description
clinical assessment
Time Frame
Change from baseline at following surgery sixth month

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Ruiz de Gopegui
Phone
0034649547011
Email
helenruizdegopegui@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Maria Garcia de la Fuente
Email
anamaria.garciad@ehu.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Antonio Aguirre Zorzano
Organizational Affiliation
University of the Basque Country (UPV/EHU)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elena Ruiz de Gopegui
Organizational Affiliation
University of the Basque Country (UPV/EHU)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana Maria Garcia de la Fuente
Organizational Affiliation
University of the Basque Country (UPV/EHU)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ruth Estefania Fresco
Organizational Affiliation
University of the Basque Country (UPV/EHU)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xavier Marichalar Mendia
Organizational Affiliation
University of the Basque Country (UPV/EHU)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jose Manuel Aguirre Urizar
Organizational Affiliation
University of the Basque Country (UPV/EHU)
Official's Role
Study Chair
Facility Information:
Facility Name
Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country
City
Leioa
State/Province
Biscay
ZIP/Postal Code
48940
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Ruiz de Gopegui Palacios
Phone
0034649547011
Email
helenruizdegopegui@gmail.com
First Name & Middle Initial & Last Name & Degree
Ana Maria Garcia de la Fuente
Email
anamaria.garciad@ehu.es
First Name & Middle Initial & Last Name & Degree
Elena Ruiz de Gopegui Palacios
First Name & Middle Initial & Last Name & Degree
Ana Maria Garcia de la Fuente
First Name & Middle Initial & Last Name & Degree
Luis Antonio Aguirre Zorzano
First Name & Middle Initial & Last Name & Degree
Ruth Estefanía Fresco
First Name & Middle Initial & Last Name & Degree
Xavier Marichalar Mendia
First Name & Middle Initial & Last Name & Degree
Jose Manuel Aguirre Urizar

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
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Clinical and Histomorphometric Analysis of Collagen Matrix Versus Connective Tissue Graft in Mucogingival Surgery in Orthodontic Patients

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