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

Last Updated: 2019-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2022-06-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Split mouth

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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Autologous connective tissue graft

Soft tissue harvesting from patient palate

Group Type ACTIVE_COMPARATOR

autologous connective tissue graft

Intervention Type OTHER

Soft tissue harvesting from patient palate with coronal advanced flap

collagen matrix

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

Group Type EXPERIMENTAL

Collagen matrix

Intervention Type DEVICE

Mucograft collagen matrix combined with coronal advanced flap

Interventions

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Collagen matrix

Mucograft collagen matrix combined with coronal advanced flap

Intervention Type DEVICE

autologous connective tissue graft

Soft tissue harvesting from patient palate with coronal advanced flap

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Elena Ruiz de Gopegui Palacios

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR