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

Study Overview
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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.

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: 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

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

Conditions
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Gingival Recession

Intervention / Treatment
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* Device: Collagen matrix
* Other: autologous connective tissue graft


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Split mouth
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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collagen matrix, connective tissue graft, xenograft, periodontal regeneration, biometry, histometry