NCT03232788

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

2.2 years

First QC Date

July 23, 2017

Last Update Submit

July 25, 2017

Conditions

RecessionPeriodontal Diseases

Keywords

Periodontal diseaseRecessionBlack space

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Depth of probing measured with a periodontal probe in millimeters

    One year

  • Clinical attachment level measured with a periodontal probe in millimeters

    One year

  • Gingival bleeding index measured with a periodontal probe

    One year

  • Radiographic bone formation measured digitally in millimeters

    One year

  • Tomographic bone formation measured digitally in cubic millimeters

    One year

  • +4 more secondary outcomes

Study Arms (2)

Test group

EXPERIMENTAL

Bone regeneration with autogenous bone + scaffold.

Procedure: Bone regenerationDevice: Scaffold

Control group

ACTIVE COMPARATOR

Bone regeneration with autogenous bone + collagen membrane.

Procedure: Bone regenerationDevice: Collagen membrane

Interventions

Bone regenerationPROCEDURE

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

Control groupTest group
Collagen membraneDEVICE

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

Control group
ScaffoldDEVICE

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

Test group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bauru School of Dentistry - University of Sao Paulo

Bauru, São Paulo, 17012-901, Brazil

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Bone Regeneration

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Bone RemodelingMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaRegenerationBiological Phenomena

Study Officials

  • Vitor T Stuni, MSc

    PhD student

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vitor T Stuani, PhD

CONTACT

+55 (18) 99748-7279vitortoledo@usp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 23, 2017

First Posted

July 28, 2017

Study Start

April 1, 2017

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

July 28, 2017

Record last verified: 2017-07

Locations

BR(1)