- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03232788
Use of Scaffolds for Treatment of Gingival Recession Associated With Interproximal Tissue Deficiency
July 25, 2017 updated by: Vitor de Toledo Stuani, University of Sao Paulo
Use of Computer Aided Design-Computer Aided Manufacturing and Additively Manufactured Scaffolds for Treatment of Gingival Recession Associated With Interproximal Tissue Deficiency
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vitor T Stuani, PhD
- Phone Number: +55 (18) 99748-7279
- Email: vitortoledo@usp.br
Study Locations
-
-
Sao Paulo
-
Bauru, Sao Paulo, Brazil, 17012-901
- Recruiting
- Bauru School of Dentistry - University of Sao Paulo
-
Contact:
- Vitor T Stuani, MSc
- Phone Number: +55 (18) 99748-7279
- Email: vitortoledo@usp.br
-
Principal Investigator:
- Vitor T Stuani, MSc
-
Sub-Investigator:
- Gustavo P Manfredi, MSc
-
Sub-Investigator:
- Adriana P Sant'Ana, PhD
-
Sub-Investigator:
- Paulo N Lisboa Filho, PhD
-
Sub-Investigator:
- Pedro Y Noritomi, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test group
Bone regeneration with autogenous bone + scaffold.
|
Autogenous bone will be placed over periodontal defect after root treatment with scaling and root planing.
A hydroxyapatite and polycaprolactone scaffolds will be used to cover the autogenous bone.
|
Active Comparator: Control group
Bone regeneration with autogenous bone + collagen membrane.
|
Autogenous bone will be placed over periodontal defect after root treatment with scaling and root planing.
A collagen membrane will be used to cover the autogenous bone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total root coverage measured with a periodontal probe in millimeters
Time Frame: One year
|
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
Time Frame: One year
|
Ideal if the distance from dental contact point to interdental papilla top = 0 mm
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depth of probing measured with a periodontal probe in millimeters
Time Frame: One year
|
The distance from gingival margin and the apical point of gingival pocket or sulcus
|
One year
|
Clinical attachment level measured with a periodontal probe in millimeters
Time Frame: One year
|
The distance from cemento-enamel junction and the apical point of gingival pocket or sulcus
|
One year
|
Gingival bleeding index measured with a periodontal probe
Time Frame: One year
|
Evaluated by the presence or absence of bleeding after probing
|
One year
|
Radiographic bone formation measured digitally in millimeters
Time Frame: One year
|
The distance from interdental bone crest and cemento-enamel junction
|
One year
|
Tomographic bone formation measured digitally in cubic millimeters
Time Frame: One year
|
The variation of bone volume observed by tomography digital reconstruction
|
One year
|
Evaluation of pink aesthetics by professionals using the Pink Esthetic Score
Time Frame: One year
|
Photographic evaluation of gingival aesthetics during the treatment done by blinded periodontists.
|
One year
|
Patient's evaluation of aesthetics using a visual analogue scale
Time Frame: One year
|
Patient's aesthetic evaluation with a score ranging from 0 (terrible aesthetic) to 10 (excellent aesthetic)
|
One year
|
Patient's evaluation of dental sensibility using a visual analogue scale
Time Frame: One year
|
Patient's dental sensibility evaluation with a score ranging from 0 (no sensibility) to 10 (intense sensibility)
|
One year
|
Patient's evaluation of post-operatory pain using a visual analogue scale
Time Frame: 1 month
|
Patient's post-operatory pain evaluation with a score ranging from 0 (no pain) to 10 (intense pain)
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vitor T Stuni, MSc, PhD student
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2017
Primary Completion (Anticipated)
July 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
July 23, 2017
First Submitted That Met QC Criteria
July 25, 2017
First Posted (Actual)
July 28, 2017
Study Record Updates
Last Update Posted (Actual)
July 28, 2017
Last Update Submitted That Met QC Criteria
July 25, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FOB3DPrint1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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