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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Bone regeneration | Autogenous bone will be placed over periodontal defect after root treatment with scaling and root planing. |
| DEVICE | Collagen membrane | A collagen membrane will be used to cover the autogenous bone. |
| DEVICE | Scaffold | A 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.