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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03533933
Enrollment
5
Registered
2018-05-23
Start date
2018-09-01
Completion date
2022-06-01
Last updated
2019-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession

Keywords

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

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

Interventions

Mucograft collagen matrix combined with coronal advanced flap

OTHERautologous connective tissue graft

Soft tissue harvesting from patient palate with coronal advanced flap

Sponsors

Elena Ruiz de Gopegui Palacios
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Intervention model description

Split mouth

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
millimeters of new attachmentChange from baseline at following surgery sixth monthhistometry assessment

Secondary

MeasureTime frameDescription
Length of new cementumChange from baseline at following surgery sixth monthhistometry assessment
Length of new junctional epitheliumChange from baseline at following surgery sixth monthhistometry assessment
length of connective attachmentChange from baseline at following surgery sixth monthhistometry assessment
complete root coverageChange from baseline at following surgery sixth monthclinical assessment
width of keratinized tissueChange from baseline at following surgery sixth monthclinical assessment

Countries

Spain

Contacts

Primary ContactElena Ruiz de Gopegui
helenruizdegopegui@gmail.com0034649547011
Backup ContactAna Maria Garcia de la Fuente
anamaria.garciad@ehu.es

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026