Clinical trial NCT03533933: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Recession
Keywords: collagen matrix
connective tissue graft
histometry
xenograft
periodontal regeneration
biometry
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split mouth
Primary purpose: TREATMENT

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:

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

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

Primary outcomes:
measure: millimeters of new attachment
timeFrame: Change from baseline at following surgery sixth month
Secondary outcomes:
measure: Length of new cementum
timeFrame: Change from baseline at following surgery sixth month
measure: Length of new junctional epithelium
timeFrame: Change from baseline at following surgery sixth month
measure: length of connective attachment
timeFrame: Change from baseline at following surgery sixth month
measure: complete root coverage
timeFrame: Change from baseline at following surgery sixth month
measure: width of keratinized tissue
timeFrame: Change from baseline at following surgery sixth month
Other outcomes:
Locations:
city: Leioa
country: Spain
facility: Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country
state: Biscay
Study officials:
affiliation: University of the Basque Country (UPV/EHU)
name: Luis Antonio Aguirre Zorzano
role: STUDY_DIRECTOR
affiliation: University of the Basque Country (UPV/EHU)
name: Elena Ruiz de Gopegui
role: PRINCIPAL_INVESTIGATOR
affiliation: University of the Basque Country (UPV/EHU)
name: Ana Maria Garcia de la Fuente
role: PRINCIPAL_INVESTIGATOR
affiliation: University of the Basque Country (UPV/EHU)
name: Ruth Estefania Fresco
role: STUDY_CHAIR
affiliation: University of the Basque Country (UPV/EHU)
name: Xavier Marichalar Mendia
role: STUDY_CHAIR
affiliation: University of the Basque Country (UPV/EHU)
name: Jose Manuel Aguirre Urizar
role: STUDY_CHAIR
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