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

Primary Purpose

Recession, Periodontal Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Bone regeneration
Collagen membrane
Scaffold
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recession focused on measuring Periodontal disease, Recession, Black space

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Bauru School of Dentistry - University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test group

Control group

Arm Description

Bone regeneration with autogenous bone + scaffold.

Bone regeneration with autogenous bone + collagen membrane.

Outcomes

Primary Outcome Measures

Total root coverage measured with a periodontal probe in millimeters
Ideal if the distance from cemento-enamel junction to gingival margin = 0 mm
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

Secondary Outcome Measures

Depth of probing measured with a periodontal probe in millimeters
The distance from gingival margin and the apical point of gingival pocket or sulcus
Clinical attachment level measured with a periodontal probe in millimeters
The distance from cemento-enamel junction and the apical point of gingival pocket or sulcus
Gingival bleeding index measured with a periodontal probe
Evaluated by the presence or absence of bleeding after probing
Radiographic bone formation measured digitally in millimeters
The distance from interdental bone crest and cemento-enamel junction
Tomographic bone formation measured digitally in cubic millimeters
The variation of bone volume observed by tomography digital reconstruction
Evaluation of pink aesthetics by professionals using the Pink Esthetic Score
Photographic evaluation of gingival aesthetics during the treatment done by blinded periodontists.
Patient's evaluation of aesthetics using a visual analogue scale
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
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
Patient's post-operatory pain evaluation with a score ranging from 0 (no pain) to 10 (intense pain)

Full Information

First Posted
July 23, 2017
Last Updated
July 25, 2017
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03232788
Brief Title
Use of Scaffolds for Treatment of Gingival Recession Associated With Interproximal Tissue Deficiency
Official Title
Use of Computer Aided Design-Computer Aided Manufacturing and Additively Manufactured Scaffolds for Treatment of Gingival Recession Associated With Interproximal Tissue Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recession, Periodontal Diseases
Keywords
Periodontal disease, Recession, Black space

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Experimental
Arm Description
Bone regeneration with autogenous bone + scaffold.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Bone regeneration with autogenous bone + collagen membrane.
Intervention Type
Procedure
Intervention Name(s)
Bone regeneration
Intervention Description
Autogenous bone will be placed over periodontal defect after root treatment with scaling and root planing.
Intervention Type
Device
Intervention Name(s)
Collagen membrane
Intervention Description
A collagen membrane will be used to cover the autogenous bone.
Intervention Type
Device
Intervention Name(s)
Scaffold
Intervention Description
A hydroxyapatite and polycaprolactone scaffolds will be used to cover the autogenous bone.
Primary Outcome Measure Information:
Title
Total root coverage measured with a periodontal probe in millimeters
Description
Ideal if the distance from cemento-enamel junction to gingival margin = 0 mm
Time Frame
One year
Title
Total interdental papilla formation measured with a periodontal probe in mm
Description
Ideal if the distance from dental contact point to interdental papilla top = 0 mm
Time Frame
One year
Secondary Outcome Measure Information:
Title
Depth of probing measured with a periodontal probe in millimeters
Description
The distance from gingival margin and the apical point of gingival pocket or sulcus
Time Frame
One year
Title
Clinical attachment level measured with a periodontal probe in millimeters
Description
The distance from cemento-enamel junction and the apical point of gingival pocket or sulcus
Time Frame
One year
Title
Gingival bleeding index measured with a periodontal probe
Description
Evaluated by the presence or absence of bleeding after probing
Time Frame
One year
Title
Radiographic bone formation measured digitally in millimeters
Description
The distance from interdental bone crest and cemento-enamel junction
Time Frame
One year
Title
Tomographic bone formation measured digitally in cubic millimeters
Description
The variation of bone volume observed by tomography digital reconstruction
Time Frame
One year
Title
Evaluation of pink aesthetics by professionals using the Pink Esthetic Score
Description
Photographic evaluation of gingival aesthetics during the treatment done by blinded periodontists.
Time Frame
One year
Title
Patient's evaluation of aesthetics using a visual analogue scale
Description
Patient's aesthetic evaluation with a score ranging from 0 (terrible aesthetic) to 10 (excellent aesthetic)
Time Frame
One year
Title
Patient's evaluation of dental sensibility using a visual analogue scale
Description
Patient's dental sensibility evaluation with a score ranging from 0 (no sensibility) to 10 (intense sensibility)
Time Frame
One year
Title
Patient's evaluation of post-operatory pain using a visual analogue scale
Description
Patient's post-operatory pain evaluation with a score ranging from 0 (no pain) to 10 (intense pain)
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vitor T Stuani, PhD
Phone
+55 (18) 99748-7279
Email
vitortoledo@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vitor T Stuni, MSc
Organizational Affiliation
PhD student
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bauru School of Dentistry - University of Sao Paulo
City
Bauru
State/Province
Sao Paulo
ZIP/Postal Code
17012-901
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vitor T Stuani, MSc
Phone
+55 (18) 99748-7279
Email
vitortoledo@usp.br
First Name & Middle Initial & Last Name & Degree
Vitor T Stuani, MSc
First Name & Middle Initial & Last Name & Degree
Gustavo P Manfredi, MSc
First Name & Middle Initial & Last Name & Degree
Adriana P Sant'Ana, PhD
First Name & Middle Initial & Last Name & Degree
Paulo N Lisboa Filho, PhD
First Name & Middle Initial & Last Name & Degree
Pedro Y Noritomi, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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