Clinical trial NCT03232788: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Recession
Periodontal Diseases
Keywords: Periodontal disease
Recession
Black space
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total root coverage measured with a periodontal probe in millimeters
timeFrame: One year
measure: Total interdental papilla formation measured with a periodontal probe in mm
timeFrame: One year
Secondary outcomes:
measure: Depth of probing measured with a periodontal probe in millimeters
timeFrame: One year
measure: Clinical attachment level measured with a periodontal probe in millimeters
timeFrame: One year
measure: Gingival bleeding index measured with a periodontal probe
timeFrame: One year
measure: Radiographic bone formation measured digitally in millimeters
timeFrame: One year
measure: Tomographic bone formation measured digitally in cubic millimeters
timeFrame: One year
measure: Evaluation of pink aesthetics by professionals using the Pink Esthetic Score
timeFrame: One year
measure: Patient's evaluation of aesthetics using a visual analogue scale
timeFrame: One year
measure: Patient's evaluation of dental sensibility using a visual analogue scale
timeFrame: One year
measure: Patient's evaluation of post-operatory pain using a visual analogue scale
timeFrame: 1 month
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Bauru School of Dentistry - University of Sao Paulo
state: Sao Paulo
Study officials:
affiliation: PhD student
name: Vitor T Stuni, MSc
role: PRINCIPAL_INVESTIGATOR
References: