RecessionNCT03232788
Use of Scaffolds for Treatment of Gingival Recession Associated With Interproximal Tissue Deficiency
A study testing Bone regeneration, Collagen membrane and Scaffold in people with Recession and Periodontal Diseases, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Recession, Periodontal Diseases
- What is being tested?
- Bone regeneration, Collagen membrane and Scaffold
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2017to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Teeth without adjacent mesial and distal contact
- Teeth with mobility
- Malpositioned teeth
- Teeth with endodontic treatment
- Teeth without a visible cementoenamel junction
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Bauru School of Dentistry - University of Sao Paulo
Bauru, São Paulo, 17012-901
Vitor T Stuani, MSc, +55 (18) 99748-7279, vitortoledo@usp.br
Vitor T Stuani, MSc
About this study
Official title: 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).
Read the 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.
- Conditions
- Recession, Periodontal Diseases
- Being tested
- Bone regeneration, Collagen membrane, Scaffold
- Keywords
- Periodontal disease, Recession, Black space
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone regenerationProcedure or surgery
Autogenous bone will be placed over periodontal defect after root treatment with scaling and root planing.
Collagen membraneDevice
A collagen membrane will be used to cover the autogenous bone.
ScaffoldDevice
A hydroxyapatite and polycaprolactone scaffolds will be used to cover the autogenous bone.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Bone regeneration with autogenous bone + scaffold. Receives: Procedure: Bone regeneration; Device: Scaffold |
| Control group | Active comparator | Bone regeneration with autogenous bone + collagen membrane. Receives: Procedure: Bone regeneration; Device: Collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total root coverage measured with a periodontal probe in millimeters
Ideal if the distance from cemento-enamel junction to gingival margin = 0 mm
Measured: One year
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
Measured: One year
Secondary outcomes (9)
Depth of probing measured with a periodontal probe in millimeters
The distance from gingival margin and the apical point of gingival pocket or sulcus
Measured: One year
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
Measured: One year
Gingival bleeding index measured with a periodontal probe
Evaluated by the presence or absence of bleeding after probing
Measured: One year
Radiographic bone formation measured digitally in millimeters
The distance from interdental bone crest and cemento-enamel junction
Measured: One year
Tomographic bone formation measured digitally in cubic millimeters
The variation of bone volume observed by tomography digital reconstruction
Measured: One year
Evaluation of pink aesthetics by professionals using the Pink Esthetic Score
Photographic evaluation of gingival aesthetics during the treatment done by blinded periodontists.
Measured: One year
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)
Measured: One year
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)
Measured: One year
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)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start1 Apr 2017
- Primary completionJul 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecessionStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vitor de Toledo Stuani, University of Sao Paulo
- Investigators
- Vitor T Stuni, MSc, Principal investigator, PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232788
- Sponsor's protocol ID
- FOB3DPrint1
- Status last verified
- Jul 2017
- First submitted
- 23 Jul 2017
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Computer Aided Design-Computer Aided Manufacturing and Additively Manufactured Scaffolds for Treatment of Gingival Recession Associated With Interproximal Tissue Deficiency
- ClinicalTrials.gov ID
- NCT03232788
- Acronym / sponsor ID
- FOB3DPrint1
- Conditions
- Recession, Periodontal Diseases
- Keywords
- Periodontal disease, Recession, Black space
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: Bone regeneration, Device: ScaffoldBone regeneration with autogenous bone + scaffold. |
| Control group | Active comparator | Procedure: Bone regeneration, Device: Collagen membraneBone regeneration with autogenous bone + collagen membrane. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone regenerationAutogenous bone will be placed over periodontal defect after root treatment with scaling and root planing. | Procedure or surgery | Control group, Test group |
| Collagen membraneA collagen membrane will be used to cover the autogenous bone. | Device | Control group |
| ScaffoldA hydroxyapatite and polycaprolactone scaffolds will be used to cover the autogenous bone. | Device | Test group |
Primary outcome
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
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
9 secondary outcomes
Depth of probing measured with a periodontal probe in millimeters
Time frame: One year
Clinical attachment level measured with a periodontal probe in millimeters
Time frame: One year
Gingival bleeding index measured with a periodontal probe
Time frame: One year
Radiographic bone formation measured digitally in millimeters
Time frame: One year
Tomographic bone formation measured digitally in cubic millimeters
Time frame: One year
Evaluation of pink aesthetics by professionals using the Pink Esthetic Score
Time frame: One year
Patient's evaluation of aesthetics using a visual analogue scale
Time frame: One year
Patient's evaluation of dental sensibility using a visual analogue scale
Time frame: One year
Patient's evaluation of post-operatory pain using a visual analogue scale
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Recession
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Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
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i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
Gingival Graft, Recession, Gingival
Not yet recruitingObservational study
Association Between Peri-implant Soft Tissue Thickness and Midfacial Marginal Mucosal Recession
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Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
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Comparative Study Of Combined Recession-Resection And Fenestration of Superior Rectus Muscle for Treatment of Dissociated Vertical Deviation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vitor T Stuni, MSc principal investigator
PhD student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone regeneration, Collagen membrane and Scaffold in people with Recession and Periodontal Diseases, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vitor T Stuani, PhD (+55 (18) 99748-7279, vitortoledo@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total root coverage measured with a periodontal probe in millimeters (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.