Use of Computer Aided Design-Computer Aided Manufacturing and Additively Manufactured Scaffolds for Treatment of Gingival Recession Associated With Interproximal Tissue Deficiency
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Sao Paulo
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Total root coverage measured with a periodontal probe in millimeters
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Presenting at least two single-rooted teeth with Miller's Class III and IV recessions with Norland & Tarnow class I, II or III papilla deficiency
Exclusion Criteria
- •History of periodontal surgery at the area on the last 12 months
- •Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based contraceptives, steroids)
- •Diabetics
- •History of head and neck radiotherapy
- •Teeth without adjacent mesial and distal contact
- •Teeth with mobility
- •Malpositioned teeth
- •Teeth with endodontic treatment
- •Teeth without a visible cementoenamel junction
Arms & Interventions
Test group
Bone regeneration with autogenous bone + scaffold.
Intervention: Bone regeneration (Procedure)
Test group
Bone regeneration with autogenous bone + scaffold.
Intervention: Scaffold (Device)
Control group
Bone regeneration with autogenous bone + collagen membrane.
Intervention: Bone regeneration (Procedure)
Control group
Bone regeneration with autogenous bone + collagen membrane.
Intervention: Collagen membrane (Device)
Outcomes
Primary Outcomes
Total root coverage measured with a periodontal probe in millimeters
Time Frame: One year
Ideal if the distance from cemento-enamel junction to gingival margin = 0 mm
Total interdental papilla formation measured with a periodontal probe in mm
Time Frame: One year
Ideal if the distance from dental contact point to interdental papilla top = 0 mm
Secondary Outcomes
- Clinical attachment level measured with a periodontal probe in millimeters(One year)
- Gingival bleeding index measured with a periodontal probe(One year)
- Depth of probing measured with a periodontal probe in millimeters(One year)
- Radiographic bone formation measured digitally in millimeters(One year)
- Tomographic bone formation measured digitally in cubic millimeters(One year)
- Evaluation of pink aesthetics by professionals using the Pink Esthetic Score(One year)
- Patient's evaluation of aesthetics using a visual analogue scale(One year)
- Patient's evaluation of dental sensibility using a visual analogue scale(One year)
- Patient's evaluation of post-operatory pain using a visual analogue scale(1 month)
Investigators
Vitor de Toledo Stuani
Principal investigator
University of Sao Paulo