Mandibular HypoplasiaPhase 1/2NCT02474615
Applicability Clinic of Cement Portland Structural White in Endodontic Surgery
A Phase 1/2 study testing ENDODONTIC SURGERY in people with Mandibular Hypoplasia, run by Universidade do Vale do Sapucai.
Trial summary
Thirty teeth twelve patients, two female and a male, who had persistent periradicular lesions were selected to participate in this study. The lesions were diagnosed with cone-beam computed tomography (cone-beam CT; Model i-Cat 17-19, Imaging Sciences International LLC).In patients with two teeth to be treated, a tooth… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandibular Hypoplasia
- What is being tested?
- ENDODONTIC SURGERY
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Jan 2015
- Phase
- Phase 1/2
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients were diagnosed by computed tomography CT, cone beam
- each of them had from two to four compromised teeth
Who cannot join
- patients who did not return for review after six months
About this study
Thirty teeth twelve patients, two female and a male, who had persistent periradicular lesions were selected to participate in this study. The lesions were diagnosed with cone-beam computed tomography (cone-beam CT; Model i-Cat 17-19, Imaging Sciences International LLC).In patients with two teeth to be treated, a tooth was retroobturado with PBEA cement, (experiment) and another tooth was retroobturado with MTA cement (control).
There was significance for the two cements on the repair of wounds. Key words: Apicoectomy; Oral Surgery; Biocompatible Materials; Dental Cements; Translational Medical Research
Read the detailed description
Objective: to evaluate the clinical applicability of structural Portland white cement additive in retrofilling surgeries. Method: persistent apical periodontitis 30 teeth of 12 patients were diagnosed by computed tomography CT, cone beam. Each of them had from two to four compromised teeth. The endodontic surgery were performed and the teeth were retrofilling Each patient had a retrofilling tooth with cement mineral trioxide aggregate (MTA) control and other tooth with white Portland cement structural additive (PBEA) experiment. When the patient presented four teeth with injury, two were retrofilling with MTA and two Portland cement with structural white cement additive. Six months after surgery, there were new scans to evaluate the repair or not the wounds.
- Conditions
- Mandibular Hypoplasia
- Being tested
- ENDODONTIC SURGERY
- Keywords
- Apicoectomy, Oral surgery, Biocompatible materials, Dental Cements, Translational Medical Research
- Medical subject headings
- Micrognathism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDODONTIC SURGERYProcedure or surgery
ENDODONTIC SURGERY
| Study group | Role | What they receive |
|---|---|---|
| TOOTH ENDODONTIC SURGERY - PBEA | Experimental | Endodontic surgery 15 teeth - PBEA Receives: Procedure: ENDODONTIC SURGERY |
| TOOTH ENDODONTIC SURGERY -MTA | Experimental | Endodontic surgery 15 teeth - MTA Receives: Procedure: ENDODONTIC SURGERY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regeneration measured by tomographers endodontic surgery
Six months after surgery, there were new scans to evaluate the repair or not the wounds.
Measured: Six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startFeb 2013
- Primary completionAug 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mandibular HypoplasiaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Sapucai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Ribeiro da Silva, Universidade do Vale do Sapucai
- Investigators
- Daniela Francescato Veiga, Study director, BRAZIL, UNIVAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474615
- Sponsor's protocol ID
- 14099
- Status last verified
- Jun 2015
- First submitted
- 24 Feb 2015
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
da Silva SR, da Silva Neto JD, Veiga DF, Schnaider TB, Ferreira LM. Portland cement versus MTA as a root-end filling material. A pilot study. Acta Cir Bras. 2015 Feb;30(2):160-4. doi: 10.1590/S0102-865020150020000011.
PubMed 25714696Silva Neto JD, Schnaider TB, Gragnani A, Paiva AP, Novo NF, Ferreira LM. Portland cement with additives in the repair of furcation perforations in dogs. Acta Cir Bras. 2012 Nov;27(11):809-14. doi: 10.1590/s0102-86502012001100011.
PubMed 23117614Feldman AM. Does academic culture support translational research? Clin Transl Sci. 2008 Sep;1(2):87-8. doi: 10.1111/j.1752-8062.2008.00046.x. No abstract available.
PubMed 20443823Silva Neto JD, Brito RH, Schnaider TB, Gragnani A, Engelman M, Ferreira LM. Root perforations treatment using mineral trioxide aggregate and Portland cements. Acta Cir Bras. 2010 Dec;25(6):479-84. doi: 10.1590/s0102-86502010000600004.
PubMed 21120277
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applicability Clinic of Cement Portland Structural White in Endodontic Surgery
- ClinicalTrials.gov ID
- NCT02474615
- Acronym / sponsor ID
- 14099
- Conditions
- Mandibular Hypoplasia
- Keywords
- Apicoectomy, Oral surgery, Biocompatible materials, Dental Cements, Translational Medical Research
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidade do Vale do SapucaiUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Jun 2015 (estimated)
- 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.
Thirty teeth twelve patients, two female and a male, who had persistent periradicular lesions were selected to participate in this study. The lesions were diagnosed with cone-beam computed tomography (cone-beam CT; Model i-Cat 17-19, Imaging Sciences International LLC).In patients with two teeth to be treated, a tooth was retroobturado with PBEA cement, (experiment) and another tooth was retroobturado with MTA cement (control).
There was significance for the two cements on the repair of wounds. Key words: Apicoectomy; Oral Surgery; Biocompatible Materials; Dental Cements; Translational Medical Research
Detailed description
Objective: to evaluate the clinical applicability of structural Portland white cement additive in retrofilling surgeries. Method: persistent apical periodontitis 30 teeth of 12 patients were diagnosed by computed tomography CT, cone beam. Each of them had from two to four compromised teeth. The endodontic surgery were performed and the teeth were retrofilling Each patient had a retrofilling tooth with cement mineral trioxide aggregate (MTA) control and other tooth with white Portland cement structural additive (PBEA) experiment. When the patient presented four teeth with injury, two were retrofilling with MTA and two Portland cement with structural white cement additive. Six months after surgery, there were new scans to evaluate the repair or not the wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOOTH ENDODONTIC SURGERY - PBEA | Experimental | Procedure: ENDODONTIC SURGERYEndodontic surgery 15 teeth - PBEA |
| TOOTH ENDODONTIC SURGERY -MTA | Experimental | Procedure: ENDODONTIC SURGERYEndodontic surgery 15 teeth - MTA |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients were diagnosed by computed tomography CT, cone beam
- each of them had from two to four compromised teeth
Key exclusion criteria (1 listed)
- patients who did not return for review after six months
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 |
|---|---|---|
| ENDODONTIC SURGERYENDODONTIC SURGERY | Procedure or surgery | TOOTH ENDODONTIC SURGERY - PBEA, TOOTH ENDODONTIC SURGERY -MTA |
Primary outcome
Regeneration measured by tomographers endodontic surgery
Time frame: Six months after surgery
Six months after surgery, there were new scans to evaluate the repair or not the wounds.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2015.
- Background: PubMed 25714696da Silva SR, da Silva Neto JD, Veiga DF, Schnaider TB, Ferreira LM. Portland cement versus MTA as a root-end filling material. A pilot study. Acta Cir Bras. 2015 Feb;30(2):160-4. doi: 10.1590/S0102-865020150020000011.
- Results publication: PubMed 23117614Silva Neto JD, Schnaider TB, Gragnani A, Paiva AP, Novo NF, Ferreira LM. Portland cement with additives in the repair of furcation perforations in dogs. Acta Cir Bras. 2012 Nov;27(11):809-14. doi: 10.1590/s0102-86502012001100011.
- Results publication: PubMed 20443823Feldman AM. Does academic culture support translational research? Clin Transl Sci. 2008 Sep;1(2):87-8. doi: 10.1111/j.1752-8062.2008.00046.x. No abstract available.
- Results publication: PubMed 21120277Silva Neto JD, Brito RH, Schnaider TB, Gragnani A, Engelman M, Ferreira LM. Root perforations treatment using mineral trioxide aggregate and Portland cements. Acta Cir Bras. 2010 Dec;25(6):479-84. doi: 10.1590/s0102-86502010000600004.
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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.
Daniela Francescato Veiga study director
BRAZIL, UNIVAS
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ENDODONTIC SURGERY in people with Mandibular Hypoplasia, run by Universidade do Vale do Sapucai.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regeneration measured by tomographers endodontic surgery (time frame: Six months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02474615, which also lists 4 linked publications.
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 18 Jun 2015.