Molar Incisor HypomineralizationNCT02717286
Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization
A study testing restorative in people with Molar Incisor Hypomineralization, run by Universidade Federal do Paraná at 1 site in Brazil.
Trial summary
The restorative management of molars with Molar-Incisor Hypomineralization (MIH) represents a challenge in the clinical practice with high failure rate. Thus, this clinical trial aimed to evaluate the clinical survival of direct composite resin restorations in first permanent molars (FPMs) that are affected by MIH… Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- restorative
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to Oct 2015
- 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children and/or parents who agree in participate of the study
- children were born and living in Araraquara, SP, Brazil
- presence of the first permanent molars totally erupted with defects classified as enamel post eruptive breakdown (PEB) or unsatisfactory atypical restoration (UATR), with or without carious lesions.
Who cannot join
- children and/or parents who do not agree in participate of the study
- first permanent molars with enamel malformation associated with syndromes,
- dental fluorosis,
- first permanent molars with destroyed crowns,
- imperfect amelogenesis
- fixed orthodontic appliances.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Survival of Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization
The restorative management of molars with Molar-Incisor Hypomineralization (MIH) represents a challenge in the clinical practice with high failure rate. Thus, this clinical trial aimed to evaluate the clinical survival of direct composite resin restorations in first permanent molars (FPMs) that are affected by MIH, comparing two adhesive systems.
Read the detailed description
For the research, it was selected first permanent molars (FPMs) with MIH from children aged 6-8 years. FPM fully erupted and with restorative treatment needed was the inclusion criteria. We excluded FPMs with destroyed crowns. The FPMs were randomly assigned to two groups: G1 (self-etching adhesive) and G2 (total-etching adhesive). Clinical evaluation was performed during 18 months according to the USPHS-Modified by a blinded examiner. The actuarial method was used to evaluate survival of the restorations and Fisher's exact test was used to compare differences between the groups (α=5%).
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- restorative
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
restorativeProcedure or surgery
It was performed direct restoration using two kinds of adhesive system (total-etching adhesive and self-etching adhesive)
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | 20 first permanent molars from children aged between 6 to 12 years old presenting MIH will be included. A calibrated pediatric dentist examined the selected teeth to classify MIH according to the European Academy of Pediatric Dentistry (EADP) criteria.
Intervention of Control: The restorative treatment using a total-etching adhesive system, which was performed according to the following operative sequence: prophylaxis, infiltrative anesthesia, rubber dam, application of 37.5% phosphoric acid to enamel (30 s) and dentine (15 s), extensive washing, drying with cotton and air jet (5 s), priming (5 s), light curing (20 s), restoration with composite resin (Filtek XT350), examination of occlusal contact, and final polishing. Receives: Procedure: restorative |
| Test | Experimental | 20 first permanent molars from children aged between 6 to 12 years old presenting Molar Incisor Hypomineralization will be included. A calibrated pediatric dentist examined the selected teeth to classify MIH according to the EAPD criteria.
Intervention of test: the restorative treatment using a self-etching adhesive system, which was performed according to the following operative sequence: prophylaxis, infiltrative anesthesia, rubber dam, application of 37.5% phosphoric acid to enamel (30 s) and dentine (15 s), extensive washing, drying with cotton and air jet (5 s), priming (5 s), air jet (5 s), adhesive application (5 s), light curing (20 s), restoration with composite resin (Filtek XT350), examination of occlusal contact, and final polishing. Receives: Procedure: restorative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rates of the direct restorative treatment
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 posted23 Mar 2016 (estimated)
- Study startJan 2013
- Primary completionOct 2013
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralizationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana Feltrin de Souza Caparroz, Universidade Federal do Paraná
- Investigators
- Rita de Cássia Loiola Cordeiro, PhD, Study chair, UNESP- Univ Estadual Paulista
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717286
- Sponsor's protocol ID
- UFParana
- Status last verified
- Mar 2016
- First submitted
- 18 Mar 2016
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival of Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization
- ClinicalTrials.gov ID
- NCT02717286
- Acronym / sponsor ID
- UFParana
- Conditions
- Molar Incisor Hypomineralization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidade Federal do ParanáUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 23 Mar 2016 (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.
The restorative management of molars with Molar-Incisor Hypomineralization (MIH) represents a challenge in the clinical practice with high failure rate. Thus, this clinical trial aimed to evaluate the clinical survival of direct composite resin restorations in first permanent molars (FPMs) that are affected by MIH, comparing two adhesive systems.
Detailed description
For the research, it was selected first permanent molars (FPMs) with MIH from children aged 6-8 years. FPM fully erupted and with restorative treatment needed was the inclusion criteria. We excluded FPMs with destroyed crowns. The FPMs were randomly assigned to two groups: G1 (self-etching adhesive) and G2 (total-etching adhesive). Clinical evaluation was performed during 18 months according to the USPHS-Modified by a blinded examiner. The actuarial method was used to evaluate survival of the restorations and Fisher's exact test was used to compare differences between the groups (α=5%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Procedure: restorative20 first permanent molars from children aged between 6 to 12 years old presenting MIH will be included. A calibrated pediatric dentist examined the selected teeth to classify MIH according to the European Academy of Pediatric Dentistry (EADP) criteria. Intervention of Control: The restorative treatment using a total-etching adhesive system, which was performed according to the following operative sequence: prophylaxis, infiltrative anesthesia, rubber dam, application of 37.5% phosphoric acid to enamel (30 s) and dentine (15 s), extensive washing, drying with cotton and air jet (5 s), priming (5 s), light curing (20 s), restoration with composite resin (Filtek XT350), examination of occlusal contact, and final polishing. |
| Test | Experimental | Procedure: restorative20 first permanent molars from children aged between 6 to 12 years old presenting Molar Incisor Hypomineralization will be included. A calibrated pediatric dentist examined the selected teeth to classify MIH according to the EAPD criteria. Intervention of test: the restorative treatment using a self-etching adhesive system, which was performed according to the following operative sequence: prophylaxis, infiltrative anesthesia, rubber dam, application of 37.5% phosphoric acid to enamel (30 s) and dentine (15 s), extensive washing, drying with cotton and air jet (5 s), priming (5 s), air jet (5 s), adhesive application (5 s), light curing (20 s), restoration with composite resin (Filtek XT350), examination of occlusal contact, and final polishing. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children and/or parents who agree in participate of the study
- children were born and living in Araraquara, SP, Brazil
- presence of the first permanent molars totally erupted with defects classified as enamel post eruptive breakdown (PEB) or unsatisfactory atypical restoration (UATR), with or without carious lesions.
Key exclusion criteria (6 listed)
- children and/or parents who do not agree in participate of the study
- first permanent molars with enamel malformation associated with syndromes,
- dental fluorosis,
- first permanent molars with destroyed crowns,
- imperfect amelogenesis
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 |
|---|---|---|
| restorativeIt was performed direct restoration using two kinds of adhesive system (total-etching adhesive and self-etching adhesive) | Procedure or surgery | Control, Test |
Primary outcome
Survival rates of the direct restorative treatment
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 30 Mar 2016.
- Individual participant dataSharing planned: Yes
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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.
Rita de Cássia Loiola Cordeiro, PhD study chair
UNESP- Univ Estadual Paulista
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing restorative in people with Molar Incisor Hypomineralization, run by Universidade Federal do Paraná 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 3 inclusion and 6 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 30 Mar 2016. 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. Some participants in this study may receive a placebo. 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?
Survival rates of the direct restorative treatment (time frame: 6 months). 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 30 Mar 2016.