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Molar Incisor HypomineralizationNCT03760497

Three Restorative Protocols in MIH: a Randomized Controlled Clinical Study

A study testing Restorative treatment in people with Molar Incisor Hypomineralization, run by University of Sao Paulo at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Molar-Incisive Hipomineralization (MIH) is defined as a qualitative change in tooth enamel of systemic origin, which affects one or more permanent first molars, and may or may not involve permanent incisors. Read more about this study

Who is it for?
Ages 6 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Molar Incisor Hypomineralization
What is being tested?
Restorative treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteBrazil
Study dates
Dec 2021to Dec 2021
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 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • At least one permanent first molar with occlusal surface with severe MIH grade (with post eruptive enamel fracture and dentin exposure), it may not be reported hypersensitivity in the selected tooth.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Brazil1 site, 1 recruiting

  • School of Dentistry of Ribeirao Preto

    Ribeirão Preto, São Paulo, 14040-904

    Fernanda Vicioni Marques, pHD Student, +55 16 999936791, fernanda.vicioni.marques@usp.br

    Fabrício Kitazono de Carvalho, Professor Doctor

    Recruiting

Other trials in Brazil

About this study

Official title: Comparison of Three Restorative Protocols in Teeth With Molar-Incisor Hipomineralization (MIH): a Randomized Controlled Clinical Study

Molar-Incisive Hipomineralization (MIH) is defined as a qualitative change in tooth enamel of systemic origin, which affects one or more permanent first molars, and may or may not involve permanent incisors. MIH has several clinical repercussions, such as presence of hypersensitivity, difficulty in local anesthesia, reduction of restorations longevity, among others, making it difficult to perform dental treatment. Therefore, the present study will evaluate, through a randomized controlled clinical study, three restorative protocols for the treatment of severe MIH (with post eruptive enamel fracture and dentin exposure). The following groups will be evaluated: direct restoration with composite resin; restoration with composite resin with diode laser application and temporary restoration with glass ionomer cement followed by restoration with composite resin). The restorations will be evaluated after 1 week, 1, 6, 12, 18 and 24 months. The main outcome will be evaluation of restoration longevity, presence of caries lesion and wear of the restoration surface. Other outcomes such as patient satisfaction with treatment, patient discomfort, anxiety, assessment of dentin sensitivity and impact on participants' quality of life, as well as the duration and cost of treatment, as well as their cost-effectiveness ratio will also be evaluated . Multilevel statistical analyzes will be performed to verify the effectiveness of diode laser treatment compared to sealing, in addition to possible factors associated with this efficacy.

Being tested
Restorative treatment
Keywords
Lasers, Hipomineralization of dental enamel, Preventive dentistry, Glass ionomer cement
Medical subject headings
Molar Hypomineralization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Restorative treatmentProcedure or surgery

    For all groups, first the patients will be submitted to the anesthetic technique indicated with Lidocaine + Epinephrine 1: 100,000 (New DFL, Rio de Janeiro, Brazil), followed by absolute isolation with rubber sheet and metal clamp; then prophylaxis of the selected tooth will be performed with Robson's brush and pumice stone and water, surface washing and drying with cotton balls, removal of carious tissue or affected enamel without dentin support with sharp curettes or low-speed spherical drills. Subsequently, each group will follow the treatment protocols suggested by the manufacturer of restorative materials.

Study groups in NCT03760497
Study groupRoleWhat they receive
CIV GroupExperimentalTemporary Restoration with Glass Ionomer (Equia Forte® - GC Corporation, Tokyo, Japan) for 30 days + Restoration in Composite Resin (Filtek® Resin Z350 XT - 3M Corporate Headquarters, St. Paul, USA).
Receives: Procedure: Restorative treatment
Composite Resin GroupExperimentalRestoration with Composite Resin (Filtek® Resin Z350 XT - 3M Corporate Headquarters, St. Paul, United States).
Receives: Procedure: Restorative treatment
Composite Resin Group + LaserExperimentalComposite Resin Restoration (Filtek® Resin Z350 XT - 3M Corporate Headquarters, St. Paul, USA) + Application of Diode Laser.
Receives: Procedure: Restorative treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Longevity of restorations

    The main purpose will be the longevity of the desserts in elaborate compounds, according to the three protocols.

    Images should be analyzed and scanned. Radiographic examination and digital radiography. After 6, 12 and 24 months.

    Measured: 24 months.

  2. Treatment satisfaction as assessed by VAS scale (Index 0 to 10)

    After 1 week of treatment, 1, 12 and 24 months, the caregiver will be asked to respond about the satisfaction regarding the care (treatment and returns) received. He should classify his satisfaction using the VAS scale with indexes from 0 to 10, with 0 being the worst treatment evaluation and 10 being the best.

    Measured: After 1 week of treatment, 1, 12 and 24 months.

  3. Discomfort referred by the children assessed by Wong-Baker Facial Scale (Very smiling to very sad)

    In order to assess the discomfort reported by the children in relation to the type of treatment received, the same timekeeping operator will apply the Wong-Baker Facial Scale to the patient, which is composed of six figures with equidistant faces. that the first one is very smiling and the expressions are changing, until the last one is very sad.

    Measured: On treatment day

  4. Quality of life assessed by Child Perceptions Questionnaire 8-10 (CPQ8-10) (Assessed by questions)

    To assess the impact of MIH on children's quality of life, the Child Perceptions Questionnaire 8-10 (CPQ8-10), specially developed for children aged 8-10 years and validated in the Portuguese language. This scale was assessed through questions and answers to a children's quality of life.

    Measured: On treatment day

  5. Anxiety Assessment

    For the assessment of anxiety in the study children, the Children's Fear Survey Schedule-Dental Subscale will be used

    Measured: On treatment day

Secondary outcomes (8)

  1. Socioeconomic questionnaire

    Information obtained through a socioeconomic questionnaire and questions related to the individual characteristics of the child, such as, for example, fluoride exposure variables, oral hygiene practices and eating habits.

    Measured: On treatment day

  2. Evaluation of the caries experience

    Evaluation of the caries experience by the ceo-d / CPO-D indices

    Measured: On treatment day

  3. Presence of biofilm visible

    Presence of biofilm visible through the Simplified Oral Hygiene Index in which six surfaces will be used to represent the entire mouth: the vestibular of the first right and left first molars, the lingual of the first right and left first molars, and the vestibular surface of the upper central incisor right and bottom left

    Measured: On treatment day

  4. Evaluation of the visible biofilm accumulated on the occlusal surface

    First the presence of dental biofilm will be evaluated visually, according to the following index: 0: absence of visible biofilm; 1: visible but difficult to identify biofilm - best verified after drying; 2: Visible and easily identifiable biofilm - even without drying

    Measured: On treatment day

  5. Evaluation of the presence of visible biofilm on the buccal surfaces of the molars to be evaluated

    0: absence of visible biofilm, 1: biofilm not visible, but removed from the gingival sulcus with the periodontal probe; 2: visible biofilm after drying; 3: abundant biofilm, visible even without drying.

    Measured: On treatment day

  6. Assessment of eruption degree

    The degree of eruption will be assessed according to the following criteria (5): A: not erupted or less than 1/3 of the erupted occlusal surface or part of the crown of the visible incisor; B: totally erupted or at least 1/3, but less than the total occlusal surface erupted and / or less than the total crown length of the visible incisor.

    Measured: On treatment day

  7. Evaluation of lesion extension

    The extent of lesion will be evaluated according to the following criterion (5): I: less than one third of the affected tooth, II: at least 1/3 of the affected tooth, but less than 2/3, III : at least 2/3 of the affected tooth.

    Measured: On treatment day

  8. Cost of procedures

    To calculate the direct costs of the procedures, the time spent in each consultation (initials and reevaluations) will be taken into account. The time will be timed and recorded in a specific clinical record. For the calculation of direct costs, the prices of consumer and permanent materials (specifications and quantity) used in each procedure, electricity and the professional fee will be considered. These values will be inferences of the market value obtained by average of different places that market the products in question, being updated during the time of the study. In addition, the cost of equipment depreciation and electricity will be calculated.

    Measured: On treatment day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2018
  2. Study startDec 2021 (estimated)
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

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
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03760497
Sponsor's protocol ID
MIHFORPUSP
Status last verified
Sep 2021
First submitted
27 Nov 2018
Last updated
28 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Restorative treatment in people with Molar Incisor Hypomineralization, 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 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: status not confirmed, as of the sponsor's last update on 28 Sep 2021. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Longevity of restorations (time frame: 24 months.). The study lists 5 primary outcomes in all. 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 NCT03760497.

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 Sep 2021.

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