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

Not Applicable

• Conditions: Recession; Periodontal Diseases
• Interventions: Procedure: Bone regeneration; Device: Collagen membrane; Device: Scaffold

• Registration Number: NCT03232788
• Lead Sponsor: University of Sao Paulo

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-04-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-23
• Study First Submitted QC: 2017-07-25
• Last Update Submitted: 2017-07-25
• Study First Posted: 2017-07-28
• Last Update Posted: 2017-07-28
• Primary Completion: 2019-07
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Bone regeneration	Bone regeneration with autogenous bone + scaffold.
Control group	Collagen membrane	Bone regeneration with autogenous bone + collagen membrane.
Test group	Scaffold	Bone regeneration with autogenous bone + scaffold.
Control group	Bone regeneration	Bone regeneration with autogenous bone + collagen membrane.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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.
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)

Trial Locations

Locations (1)

Bauru School of Dentistry - University of Sao Paulo; 🇧🇷 Bauru, Sao Paulo, Brazil