An interventional study of Collagen matrix and autologous connective tissue graft in Gingival Recession, sponsored by Elena Ruiz de Gopegui Palacios. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-23.
Sponsored by Elena Ruiz de Gopegui Palacios · Not applicable, Interventional, and Treatment
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.
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:
413 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.
This study's planned enrollment of 5 is below the median of 30 across 379 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →This is the only study on the registry with Elena Ruiz de Gopegui Palacios as lead sponsor.
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Exclusion Criteria:
Soft tissue harvesting from patient palate
Other: autologous connective tissue graft
Mucograft collagen matrix manufactured by Geistlich AG, Switzerland Device: Collagen matrix
Device: Collagen matrix
Mucograft collagen matrix combined with coronal advanced flap
Soft tissue harvesting from patient palate with coronal advanced flap
millimeters of new attachment
histometry assessment
Time frame: Change from baseline at following surgery sixth month
Length of new cementum
histometry assessment
Time frame: Change from baseline at following surgery sixth month
Length of new junctional epithelium
histometry assessment
Time frame: Change from baseline at following surgery sixth month
length of connective attachment
histometry assessment
Time frame: Change from baseline at following surgery sixth month
complete root coverage
clinical assessment
Time frame: Change from baseline at following surgery sixth month
width of keratinized tissue
clinical assessment
Time frame: Change from baseline at following surgery sixth month
Plan to share: Yes — The data collected for the study will be identified by a code and only the researcher will be able to relate them. The personal data will be treated with absolute confidentiality in accordance with the Data Protection Law and will remain in the patient's clinical history. The coded data will be included in a UPV/EHU´s file with reference number 2080310015-INA0110, whose head is Ana María García de la Fuente, and will only be used for the purposes of this project.
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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