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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Autogenous bone will be placed over periodontal defect after root treatment with scaling and root planing.
A collagen membrane will be used to cover the autogenous bone.
A hydroxyapatite and polycaprolactone scaffolds will be used to cover the autogenous bone.
Bauru School of Dentistry - University of Sao Paulo
Bauru, São Paulo, Brazil
RECRUITINGTotal root coverage measured with a periodontal probe in millimeters
Ideal if the distance from cemento-enamel junction to gingival margin = 0 mm
Time frame: One year
Total interdental papilla formation measured with a periodontal probe in mm
Ideal if the distance from dental contact point to interdental papilla top = 0 mm
Time frame: One year
Depth of probing measured with a periodontal probe in millimeters
The distance from gingival margin and the apical point of gingival pocket or sulcus
Time frame: One year
Clinical attachment level measured with a periodontal probe in millimeters
The distance from cemento-enamel junction and the apical point of gingival pocket or sulcus
Time frame: One year
Gingival bleeding index measured with a periodontal probe
Evaluated by the presence or absence of bleeding after probing
Time frame: One year
Radiographic bone formation measured digitally in millimeters
The distance from interdental bone crest and cemento-enamel junction
Time frame: One year
Tomographic bone formation measured digitally in cubic millimeters
The variation of bone volume observed by tomography digital reconstruction
Time frame: One year
Evaluation of pink aesthetics by professionals using the Pink Esthetic Score
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Photographic evaluation of gingival aesthetics during the treatment done by blinded periodontists.
Time frame: One year
Patient's evaluation of aesthetics using a visual analogue scale
Patient's aesthetic evaluation with a score ranging from 0 (terrible aesthetic) to 10 (excellent aesthetic)
Time frame: One year
Patient's evaluation of dental sensibility using a visual analogue scale
Patient's dental sensibility evaluation with a score ranging from 0 (no sensibility) to 10 (intense sensibility)
Time frame: One year
Patient's evaluation of post-operatory pain using a visual analogue scale
Patient's post-operatory pain evaluation with a score ranging from 0 (no pain) to 10 (intense pain)
Time frame: 1 month