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

University of Sao Paulo

Status: Unknown

Conditions: Recession; Periodontal Diseases

Treatments: Device: Scaffold; Procedure: Bone regeneration; Device: Collagen membrane

Study type: Interventional

Funder types: Other

Identifiers

NCT03232788

FOB3DPrint1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Test group

Experimental group

Description:

Bone regeneration with autogenous bone + scaffold.

Treatment:

Procedure: Bone regeneration

Device: Scaffold

Control group

Active Comparator group

Description:

Bone regeneration with autogenous bone + collagen membrane.

Treatment:

Device: Collagen membrane

Procedure: Bone regeneration