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

U

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

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

Trial contacts and locations

1

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Central trial contact

Vitor T Stuani, PhD

Data sourced from clinicaltrials.gov

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