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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2019-12-31

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).

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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.

Conditions

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Recession Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Test group

Bone regeneration with autogenous bone + scaffold.

Group Type EXPERIMENTAL

Bone regeneration

Intervention Type PROCEDURE

Autogenous bone will be placed over periodontal defect after root treatment with scaling and root planing.

Scaffold

Intervention Type DEVICE

A hydroxyapatite and polycaprolactone scaffolds will be used to cover the autogenous bone.

Control group

Bone regeneration with autogenous bone + collagen membrane.

Group Type ACTIVE_COMPARATOR

Bone regeneration

Intervention Type PROCEDURE

Autogenous bone will be placed over periodontal defect after root treatment with scaling and root planing.

Collagen membrane

Intervention Type DEVICE

A collagen membrane will be used to cover the autogenous bone.

Interventions

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Bone regeneration

Autogenous bone will be placed over periodontal defect after root treatment with scaling and root planing.

Intervention Type PROCEDURE

Collagen membrane

A collagen membrane will be used to cover the autogenous bone.

Intervention Type DEVICE

Scaffold

A hydroxyapatite and polycaprolactone scaffolds will be used to cover the autogenous bone.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes