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

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ClinicalTrials.gov Identifier: NCT03232788
Recruitment Status : Recruiting
First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Vitor de Toledo Stuani, University of Sao Paulo

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).

Condition or disease Intervention/treatment Phase
Recession Periodontal Diseases Procedure: Bone regeneration Device: Collagen membrane Device: Scaffold Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Use of Computer Aided Design-Computer Aided Manufacturing and Additively Manufactured Scaffolds for Treatment of Gingival Recession Associated With Interproximal Tissue Deficiency
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Test group
Bone regeneration with autogenous bone + scaffold.
Procedure: Bone regeneration
Autogenous bone will be placed over periodontal defect after root treatment with scaling and root planing.

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

Active Comparator: Control group
Bone regeneration with autogenous bone + collagen membrane.
Procedure: Bone regeneration
Autogenous bone will be placed over periodontal defect after root treatment with scaling and root planing.

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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Gingival bleeding index measured with a periodontal probe [ Time Frame: One year ]
    Evaluated by the presence or absence of bleeding after probing

  4. Radiographic bone formation measured digitally in millimeters [ Time Frame: One year ]
    The distance from interdental bone crest and cemento-enamel junction

  5. Tomographic bone formation measured digitally in cubic millimeters [ Time Frame: One year ]
    The variation of bone volume observed by tomography digital reconstruction

  6. 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.

  7. 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)

  8. 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)

  9. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232788


Contacts
Contact: Vitor T Stuani, PhD +55 (18) 99748-7279 vitortoledo@usp.br

Locations
Brazil
Bauru School of Dentistry - University of Sao Paulo Recruiting
Bauru, Sao Paulo, Brazil, 17012-901
Contact: Vitor T Stuani, MSc    +55 (18) 99748-7279    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         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Vitor T Stuni, MSc PhD student

Responsible Party: Vitor de Toledo Stuani, Principal investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03232788     History of Changes
Other Study ID Numbers: FOB3DPrint1
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vitor de Toledo Stuani, University of Sao Paulo:
Periodontal disease
Recession
Black space

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Gingival Recession
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy