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

NCT03533933 | Unknown DMC

• 1 other identifier: MCP-2
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession

Keywords

collagen matrix; connective tissue graft; histometry; xenograft; periodontal regeneration; biometry

Outcome Measures

Primary Outcomes (1)

• millimeters of new attachment

  histometry assessment

  Change from baseline at following surgery sixth month

Secondary Outcomes (5)

• Length of new cementum

  Change from baseline at following surgery sixth month

• Length of new junctional epithelium

  Change from baseline at following surgery sixth month

• length of connective attachment

  Change from baseline at following surgery sixth month

• complete root coverage

  Change from baseline at following surgery sixth month

• width of keratinized tissue

  Change from baseline at following surgery sixth month

Study Arms (2)

Autologous connective tissue graft

ACTIVE COMPARATOR

Soft tissue harvesting from patient palate

Other: autologous connective tissue graft

collagen matrix

EXPERIMENTAL

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

Device: Collagen matrix

Interventions

Collagen matrix DEVICE

Mucograft collagen matrix combined with coronal advanced flap

collagen matrix

autologous connective tissue graft OTHER

Soft tissue harvesting from patient palate with coronal advanced flap

Autologous connective tissue graft

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elena Ruiz de Gopegui Palacios: lead

Study Sites (1)

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

Leioa, Biscay, 48940, Spain

RECRUITING

Related Publications (28)

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MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Luis Antonio Aguirre Zorzano

  University of the Basque Country (UPV/EHU)

  STUDY DIRECTOR

• 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)

  PRINCIPAL INVESTIGATOR

• 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)

  STUDY CHAIR

Central Study Contacts

Elena Ruiz de Gopegui

CONTACT

0034649547011; helenruizdegopegui@gmail.com

Ana Maria Garcia de la Fuente

CONTACT

anamaria.garciad@ehu.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Analyst and Histometry: The statistician and the pathologist does not know which treatment corresponds to each variable.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Split mouth

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: May 23, 2018
• Study Start: September 1, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)