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

Sponsor

Elena Ruiz de Gopegui Palacios (Other)

Overall Status

Unknown status

CT.gov ID

NCT03533933

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gingival Recession	Device: Collagen matrix Other: autologous connective tissue graft	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Split mouthSplit mouth

Masking:

Single (Outcomes Assessor)

Masking Description:

Analyst and Histometry: The statistician and the pathologist does not know which treatment corresponds to each variable.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2018

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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
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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

millimeters of new attachment [Change from baseline at following surgery sixth month]
histometry assessment

Secondary Outcome Measures

Length of new cementum [Change from baseline at following surgery sixth month]
histometry assessment
Length of new junctional epithelium [Change from baseline at following surgery sixth month]
histometry assessment
length of connective attachment [Change from baseline at following surgery sixth month]
histometry assessment
complete root coverage [Change from baseline at following surgery sixth month]
clinical assessment
width of keratinized tissue [Change from baseline at following surgery sixth month]
clinical assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country	Leioa	Biscay	Spain	48940

Sponsors and Collaborators

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: Ruth Estefania Fresco, University of the Basque Country (UPV/EHU)
Study Chair: Xavier Marichalar Mendia, University of the Basque Country (UPV/EHU)
Study Chair: Jose Manuel Aguirre Urizar, University of the Basque Country (UPV/EHU)