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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Recession, Periodontal Diseases

Intervention / Treatment
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* Procedure: Bone regeneration
* Device: Collagen membrane
* Device: Scaffold


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>Bone regeneration with autogenous bone + scaffold. | Procedure: Bone regeneration<br>* Autogenous bone will be placed over periodontal defect after root treatment with scaling and root planing.<br>Device: Scaffold<br>* A hydroxyapatite and polycaprolactone scaffolds will be used to cover the autogenous bone.<br>|
| Active Comparator: Control group<br>Bone regeneration with autogenous bone + collagen membrane. | Procedure: Bone regeneration<br>* Autogenous bone will be placed over periodontal defect after root treatment with scaling and root planing.<br>Device: Collagen membrane<br>* A collagen membrane will be used to cover the autogenous bone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total root coverage measured with a periodontal probe in millimeters | Ideal if the distance from cemento-enamel junction to gingival margin = 0 mm | 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 | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depth of probing measured with a periodontal probe in millimeters | The distance from gingival margin and the apical point of gingival pocket or sulcus | 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 | One year | 
| Gingival bleeding index measured with a periodontal probe | Evaluated by the presence or absence of bleeding after probing | One year | 
| Radiographic bone formation measured digitally in millimeters | The distance from interdental bone crest and cemento-enamel junction | One year | 
| Tomographic bone formation measured digitally in cubic millimeters | The variation of bone volume observed by tomography digital reconstruction | One year | 
| Evaluation of pink aesthetics by professionals using the Pink Esthetic Score | Photographic evaluation of gingival aesthetics during the treatment done by blinded periodontists. | 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) | 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) | 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) | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontal disease, Recession, Black space