Clinical Trials Directory

Trials / Unknown

UnknownNCT03232788

Use of Scaffolds for Treatment of Gingival Recession Associated With Interproximal Tissue Deficiency

Use of Computer Aided Design-Computer Aided Manufacturing and Additively Manufactured Scaffolds for Treatment of Gingival Recession Associated With Interproximal Tissue Deficiency

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
University of Sao Paulo · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

This study will seek to evaluate the predictability and efficacy of a Computer Aided Design-Computer Aided Manufacturing and additively manufactured polycaprolactone and hydroxyapatite scaffolds in these defects compared to traditional guided tissue regeneration. 40 gingival recessions associated with interproximal tissue deficiency will be divided into two groups: control group (autogenous bone + collagen membrane; n = 20) and test group (autogenous bone + scaffold; n = 20).

Detailed description

The treatment of gingival recessions associated with interproximal bone and gingival tissue deficiency, and also the absence of interdental papilla, are major challenges within the periodontics due to lacking predictability. However, an intervention in these cases is extremely important, since the presence of these defects is associated with aesthetic, phonetic, hypersensitivity and may be associated with other dental damages. This study will seek to evaluate the predictability and efficacy of a Computer Aided Design-Computer Aided Manufacturing and additively manufactured polycaprolactone and hydroxyapatite scaffolds in these defects compared to traditional guided tissue regeneration. 40 gingival recessions associated with interproximal tissue deficiency will be divided into two groups: control group (autogenous bone + collagen membrane; n = 20) and test group (autogenous bone + scaffold; n = 20). A split-mouth design will be used with both procedures performed at the same surgical time.

Conditions

Interventions

TypeNameDescription
PROCEDUREBone regenerationAutogenous bone will be placed over periodontal defect after root treatment with scaling and root planing.
DEVICECollagen membraneA collagen membrane will be used to cover the autogenous bone.
DEVICEScaffoldA hydroxyapatite and polycaprolactone scaffolds will be used to cover the autogenous bone.

Timeline

Start date
2017-04-01
Primary completion
2019-07-01
Completion
2019-12-01
First posted
2017-07-28
Last updated
2017-07-28

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT03232788. Inclusion in this directory is not an endorsement.