Recession, Periodontal Diseases
Conditions
Keywords
Periodontal disease, Recession, Black space
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.
Interventions
PROCEDUREBone regeneration
Autogenous bone will be placed over periodontal defect after root treatment with scaling and root planing.
DEVICECollagen membrane
A collagen membrane will be used to cover the autogenous bone.
DEVICEScaffold
A hydroxyapatite and polycaprolactone scaffolds will be used to cover the autogenous bone.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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) * Pregnant * Smokers * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total root coverage measured with a periodontal probe in millimeters | 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 | One year | Ideal if the distance from dental contact point to interdental papilla top = 0 mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gingival bleeding index measured with a periodontal probe | One year | Evaluated by the presence or absence of bleeding after probing |
| Radiographic bone formation measured digitally in millimeters | One year | The distance from interdental bone crest and cemento-enamel junction |
| Tomographic bone formation measured digitally in cubic millimeters | One year | The variation of bone volume observed by tomography digital reconstruction |
| Depth of probing measured with a periodontal probe in millimeters | One year | The distance from gingival margin and the apical point of gingival pocket or sulcus |
| Patient's evaluation of aesthetics using a visual analogue scale | One year | Patient's aesthetic evaluation with a score ranging from 0 (terrible aesthetic) to 10 (excellent aesthetic) |
| Patient's evaluation of dental sensibility using a visual analogue scale | One year | Patient's dental sensibility evaluation with a score ranging from 0 (no sensibility) to 10 (intense sensibility) |
| Patient's evaluation of post-operatory pain using a visual analogue scale | 1 month | Patient's post-operatory pain evaluation with a score ranging from 0 (no pain) to 10 (intense pain) |
| Evaluation of pink aesthetics by professionals using the Pink Esthetic Score | One year | Photographic evaluation of gingival aesthetics during the treatment done by blinded periodontists. |
| Clinical attachment level measured with a periodontal probe in millimeters | One year | The distance from cemento-enamel junction and the apical point of gingival pocket or sulcus |
Countries
Brazil
Contacts
Primary ContactVitor T Stuani, PhD
Outcome results
None listed