ApexificationNCT03112291
Antimicrobial Pastes and Clinical Cases of Apexogenesis
A study testing Apexification in people with Apexification and Root Canal Therapy, run by Adriana Kelly de Sousa Santiago Barbosa at 1 site in Brazil.
Trial summary
The aim of this study was to perform a clinical and microbiological evaluation of teeth with incomplete apexogenesis and traumatic necrosis that were treated with a revascularization technique, evaluating the microbial reduction after the use a double antibiotic paste. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Apexification, Root Canal Therapy, Dental Trauma
- What is being tested?
- Apexification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Nov 2011to 8 Oct 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- They should have one permanent tooth with traumatic necrosis, which in turns should show color alteration, fistulae, periapical lesion, and/or internal or external root resorption, pain, or absence of pulp response to sensitivity tests at a clinical examination to be considered necrotic. Male and female patients who had not undergone antibiotic therapy 3 months before the treatment were included and clinical and radiographic examinations confirmed pulp necrosis.
Who cannot join
- Patients who did use antibiotics
- Patients who did loss of temporary coronary sealing between treatment sessions
- Patients who give up the research
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Adriana Kelly de Sousa Santiago Barbosa
Fortaleza, Ceará, 60861635
About this study
Official title: Clinical and Microbiological Evaluation of a Series of Clinical Cases of Permanent Teeth With Incomplete Apexogenesis and Traumatic Necrosis, Treated With Double Antimicrobial Paste, Revascularization Procedures, and MTA
The aim of this study was to perform a clinical and microbiological evaluation of teeth with incomplete apexogenesis and traumatic necrosis that were treated with a revascularization technique, evaluating the microbial reduction after the use a double antibiotic paste. Furthermore, the investigation also aims to identify the presence of Enterococcus faecalis and Porphyromomas gingivalis within the root canal system.
Read the detailed description
This investigation is a longitudinal prospective interventional study of a series of cases. Patients who sought treatment at the Faculty of Dentistry from June 2011 to September 2015 were selected. They should have one permanent tooth with traumatic necrosis.
- Conditions
- Apexification, Root Canal Therapy, Dental Trauma
- Being tested
- Apexification
- Keywords
- anti-microbial agents, apexification, dental pulp, endodontics, root canal therapy, dental trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApexificationProcedure or surgery
Also called Pulp Revascularization
Apexification forms a calcified barrier in teeth with open apexes and pulp necrosis. It is used to treat immature teeth, but it does not promote the continuity of root formation.
| Study group | Role | What they receive |
|---|---|---|
| permanent teeth apexification | Experimental | They should have one permanent tooth with traumatic necrosis, which in turns should show color alteration, fistulae, periapical lesion, and/or internal or external root resorption, pain, or absence of pulp response to sensitivity tests at a clinical examination to be considered necrotic. Male and female patients who had not undergone antibiotic therapy 3 months before the treatment were included and clinical and radiographic examinations confirmed pulp necrosis. This study analyzed the clinical and microbiological results of the endodontic treatment performed on permanent teeth with necrosis caused by traumatic injury and treated using revascularization technique, double antibiotic paste, intra-canal medication, and an MTA cervical plug. Receives: Procedure: Apexification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of teeth with apex closed according to nolle stages.
The apical closure of the teeth was evaluated by radiography /computed tomography every 3 months according to the nolla stages, in which a tooth is considered to be a closed apex in stage 9 of nolla
Measured: 24 months
Secondary outcomes (1)
Number of patients with clinically and radiographically observed fistulas
The occurrence of fistulas through clinical signs and symptoms was observed for a period of 6 months in which it was recorded in medical records
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start25 Nov 2011
- Primary completion10 Jun 2015
- Study completion8 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ApexificationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This investigation is a longitudinal prospective interventional study of a series of cases
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adriana Kelly de Sousa Santiago Barbosa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adriana Kelly de Sousa Santiago Barbosa, Universidade Federal do Ceara
- Investigators
- José Jeová S Moreira Neto, Dr, Study director, Universidade Federal do Ceara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112291
- Sponsor's protocol ID
- Estudo Clinico - Apicificação
- Status last verified
- Apr 2017
- First submitted
- 4 Apr 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pace R, Giuliani V, Nieri M, Di Nasso L, Pagavino G. Mineral trioxide aggregate as apical plug in teeth with necrotic pulp and immature apices: a 10-year case series. J Endod. 2014 Aug;40(8):1250-4. doi: 10.1016/j.joen.2013.12.007. Epub 2014 Apr 3.
PubMed 25069943Nagata JY, Gomes BP, Rocha Lima TF, Murakami LS, de Faria DE, Campos GR, de Souza-Filho FJ, Soares Ade J. Traumatized immature teeth treated with 2 protocols of pulp revascularization. J Endod. 2014 May;40(5):606-12. doi: 10.1016/j.joen.2014.01.032. Epub 2014 Mar 6.
PubMed 24767551Trope M. Treatment of the immature tooth with a non-vital pulp and apical periodontitis. Dent Clin North Am. 2010 Apr;54(2):313-24. doi: 10.1016/j.cden.2009.12.006.
PubMed 20433980
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Evaluation of a Series of Clinical Cases of Permanent Teeth With Incomplete Apexogenesis and Traumatic Necrosis, Treated With Double Antimicrobial Paste, Revascularization Procedures, and MTA
- ClinicalTrials.gov ID
- NCT03112291
- Acronym / sponsor ID
- Estudo Clinico - Apicificação
- Conditions
- Apexification, Root Canal Therapy, Dental Trauma
- Keywords
- anti-microbial agents, apexification, dental pulp, endodontics, root canal therapy, dental trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Adriana Kelly de Sousa Santiago BarbosaUniversity, hospital or other
- Study start
- 25 Nov 2011 (actual)
- Primary completion
- 10 Jun 2015 (actual)
- Study completion
- 8 Oct 2016 (actual)
- First posted
- 13 Apr 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.
The aim of this study was to perform a clinical and microbiological evaluation of teeth with incomplete apexogenesis and traumatic necrosis that were treated with a revascularization technique, evaluating the microbial reduction after the use a double antibiotic paste. Furthermore, the investigation also aims to identify the presence of Enterococcus faecalis and Porphyromomas gingivalis within the root canal system.
Detailed description
This investigation is a longitudinal prospective interventional study of a series of cases. Patients who sought treatment at the Faculty of Dentistry from June 2011 to September 2015 were selected. They should have one permanent tooth with traumatic necrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This investigation is a longitudinal prospective interventional study of a series of cases
| Arm | Type | Receives |
|---|---|---|
| permanent teeth apexification | Experimental | Procedure: ApexificationThey should have one permanent tooth with traumatic necrosis, which in turns should show color alteration, fistulae, periapical lesion, and/or internal or external root resorption, pain, or absence of pulp response to sensitivity tests at a clinical examination to be considered necrotic. Male and female patients who had not undergone antibiotic therapy 3 months before the treatment were included and clinical and radiographic examinations confirmed pulp necrosis. This study analyzed the clinical and microbiological results of the endodontic treatment performed on permanent teeth with necrosis caused by traumatic injury and treated using revascularization technique, double antibiotic paste, intra-canal medication, and an MTA cervical plug. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- They should have one permanent tooth with traumatic necrosis, which in turns should show color alteration, fistulae, periapical lesion, and/or internal or external root resorption, pain, or absence of pulp response to sensitivity tests at a clinical examination to be considered necrotic. Male and female patients who had not undergone antibiotic therapy 3 months before the treatment were included and clinical and radiographic examinations confirmed pulp necrosis.
Key exclusion criteria (3 listed)
- Patients who did use antibiotics
- Patients who did loss of temporary coronary sealing between treatment sessions
- Patients who give up the research
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 |
|---|---|---|
| ApexificationAlso: Pulp RevascularizationApexification forms a calcified barrier in teeth with open apexes and pulp necrosis. It is used to treat immature teeth, but it does not promote the continuity of root formation. | Procedure or surgery | permanent teeth apexification |
Primary outcome
Number of teeth with apex closed according to nolle stages.
Time frame: 24 months
The apical closure of the teeth was evaluated by radiography /computed tomography every 3 months according to the nolla stages, in which a tooth is considered to be a closed apex in stage 9 of nolla
1 secondary outcome
Number of patients with clinically and radiographically observed fistulas
Time frame: 6 months
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 13 Apr 2017.
- Background: PubMed 25069943Pace R, Giuliani V, Nieri M, Di Nasso L, Pagavino G. Mineral trioxide aggregate as apical plug in teeth with necrotic pulp and immature apices: a 10-year case series. J Endod. 2014 Aug;40(8):1250-4. doi: 10.1016/j.joen.2013.12.007. Epub 2014 Apr 3.
- Results publication: PubMed 24767551Nagata JY, Gomes BP, Rocha Lima TF, Murakami LS, de Faria DE, Campos GR, de Souza-Filho FJ, Soares Ade J. Traumatized immature teeth treated with 2 protocols of pulp revascularization. J Endod. 2014 May;40(5):606-12. doi: 10.1016/j.joen.2014.01.032. Epub 2014 Mar 6.
- Results publication: PubMed 20433980Trope M. Treatment of the immature tooth with a non-vital pulp and apical periodontitis. Dent Clin North Am. 2010 Apr;54(2):313-24. doi: 10.1016/j.cden.2009.12.006.
- Individual participant dataSharing planned: No
Related trials for Apexification
RecruitingObservational study
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Dental Restoration, Permanent, Dental Restorations
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.
José Jeová S Moreira Neto, Dr study director
Universidade Federal do Ceara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apexification in people with Apexification and Root Canal Therapy, run by Adriana Kelly de Sousa Santiago Barbosa 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 3 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 13 Apr 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?
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?
Number of teeth with apex closed according to nolle stages. (time frame: 24 months). 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 NCT03112291, which also lists 3 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 13 Apr 2017.