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

Periodontal Diseases Clinical Trial

Official title:

Use of Computer Aided Design-Computer Aided Manufacturing and Additively Manufactured Scaffolds for Treatment of Gingival Recession Associated With Interproximal Tissue Deficiency

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03232788
• Other study ID #: FOB3DPrint1
• Status: Recruiting
• Phase: N/A
• First received: July 23, 2017
• Last updated: July 25, 2017
• Start date: April 1, 2017
• Est. completion date: December 2019

Study information

• Verified date: July 2017
• Source: University of Sao Paulo
• Contact: Vitor T Stuani, PhD
• Phone: +55 (18) 99748-7279
• Email: vitortoledo[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Diseases
• Gingival Recession
• Periodontal Diseases
• Recession

Intervention

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

Locations

Country	Name	City	State
Brazil	Bauru School of Dentistry - University of Sao Paulo	Bauru	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Depth of probing measured with a periodontal probe in millimeters	The distance from gingival margin and the apical point of gingival pocket or sulcus	One year
Secondary	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	One year
Secondary	Gingival bleeding index measured with a periodontal probe	Evaluated by the presence or absence of bleeding after probing	One year
Secondary	Radiographic bone formation measured digitally in millimeters	The distance from interdental bone crest and cemento-enamel junction	One year
Secondary	Tomographic bone formation measured digitally in cubic millimeters	The variation of bone volume observed by tomography digital reconstruction	One year
Secondary	Evaluation of pink aesthetics by professionals using the Pink Esthetic Score	Photographic evaluation of gingival aesthetics during the treatment done by blinded periodontists.	One year
Secondary	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)	One year
Secondary	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)	One year
Secondary	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)	1 month