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Fracture Prevention in Permanent Molars with Developmental Defects of Enamel

Effectiveness of Sealing of Pits and Fissures in Hypomineralized First Permanent Molars

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3xwprn
Enrollment
Unknown
Registered
2020-03-09
Start date
2019-10-09
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental caries

Interventions

• tooth surface (pit and fissures) cleaning with rubber cup and pum
Both TEST (sample of 41 participants) and CONTROL (sample of 41 participants) interventions will be done in a dental office using disposable and sterilized dental instruments, following the recommende
• rinsing thoroughly with water followed by air-drying
• isolation with cotton rolls
• surface conditioning with 10% poliacrylic acid for 10 seconds
• rinsing throughly with water followed by air-drying
• capsule activation and mixing in an amalgamator for 10 seconds
• dispensation of the high viscosity glass ionomer cement on the tooth surface sealing all the pits and fissures completely
• finger pressure to ensure the complete filling of the pits and fissures
• occlusal contacts checking with a carbon paper
• removal of the excess using an instrument and/or finishing burr
• application of the finishing coat
• lightcuring for 20 seconds. CG-RS: • papilla local anesthesia using lidocaine 2% 1:100.000 followed by isolation with clamp and rubber dam
Procedure/surgery

Sponsors

Universidade do Estado do Rio de Janeiro
Lead Sponsor
Universidade do Estado do Rio de Janeiro
Collaborator

Eligibility

Age
7 Years to 10 Years

Inclusion criteria

Inclusion criteria: Healthy children, 7 to 10 years-old, with molar incisor hypomineralization diagnosed according to the European Academy of Pediatric Dentistry criteria. Patients must present at least one permanent first molar with creamy-whitish or yellow-brownish demarcated opacity without post-eruptive breakdown or dentin caries.

Exclusion criteria

Exclusion criteria: Children with other enamel developmental defects than molar incisor hypomineralization, with fixed orthodontic appliance or who are unable to cooperate during dental treatment will be excluded.

Design outcomes

Primary

MeasureTime frame
The effect of sealing on the prevention of post-eruptive breakdown at the tooth level, will be assessed by tactile-visual examination of the tooth surfaces according to the criteria proposed by the European Academy of Pediatric Dentistry following the scores described below: Score 1: creamy-whitish opacity = absence of post-eruptive breakdown; Score 2: yellow-brownish opacity = absence of post-eruptive breakdown; Score 3: lost of enamel integrity restricted to enamel = presence of post-eruptive breakdown; Score 4: lost of enamel integrity exposing dentin = presence of post-eruptive breakdown; Score 5: presence of an atypical restoration = presence of post-eruptive breakdown. The main outcome, absence/presence of post-eruptive breakdown, will be assessed every 6 months, along the total period of 36 months. The effect of the TEST intervention in preventing post-eruptive breakdown will be assessed comparing the proportion of teeth with no post-eruptive breakdown between TEST and CONTROL group using the Kaplan-Meier survival analysis.

Secondary

MeasureTime frame
The retention rate of fissure sealant, at the tooth level, assessed by tactile-visual, using dental mirror and explorer, examination of the tooth surfaces, every 6 months along the total period of 36 months. The retention rate of the sealants will be assessed according to Oulis and Berdouses (Eur Arch Paediatr Dent. 2009;10(4):211–7). At the tooth level, the sealant will be scored as: 1- totally retained; 2- partially retained; or 3- totally lost. The success rate of the TEST intervention will be assessed comparing the proportion of teeth with totally retained sealant between TEST and CONTROL group using the Kaplan-Meier survival analysis.;The dentin caries prevention rate, at the tooth level, assessed by tactile-visual, using dental mirror and explorer, examination of the tooth surfaces, every 6 months along the total period of 36 months. Dentin caries prevention rate: The presence or absence of dentin caries will be assessed according to Nyvad criteria (Caries Res. 1999;33(4):252-60). At the tooth level, dentin caries will be considered present when the caries score is 3 or 6 represented by the presence of cavitation, exposing dentin. The effect of the TEST intervention in preventing dentin caries will be assessed comparing the proportion of teeth with no dentin caries between TEST and CONTROL group using the Kaplan-Meier survival analysis.

Countries

Brazil

Contacts

Public ContactRoberta Jorge

Faculdade Arthur Sá Earp Neto

robertacjorge@gmail.com21981296195

Outcome results

None listed

Source: REBEC (via WHO ICTRP)