Skip to content

Conservative steel crowns for the management of dental enamel defects in permanent molars: a randomized controlled trial

Hall Technique for the management of Hypomineralized first permanent molars: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4mtq8d9
Enrollment
Unknown
Registered
2023-05-29
Start date
2023-05-01
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 Hypomineralization

Interventions

Seven experienced clinicians who work as dentists at the public oral health system will be the operators and will perform the interventions. Each of the dentists will treat 14 patients. In total, ther

Sponsors

Programa de Pós-graduação Stricto sensu em Odontologia - Faculdade de Odontologia - Universidade do Estado do Rio de Janeiro
Lead Sponsor
Programa de Pós-graduação Stricto sensu em Odontologia - Faculdade de Odontologia - Universidade do Estado do Rio de Janeiro
Collaborator

Eligibility

Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children with at least one first permanent molar affected by molar incisor hypomineralization (MIH) with post-eruptive breakdown; atypical carious lesions; or atypical restoration affecting at least two tooth-surfaces and involving at least one cusp will be eligible for the study

Exclusion criteria

Exclusion criteria: Children presenting other developmental enamel defect than molar incisor hypomineralization (e.g., amelogenesis imperfecta, severe fluorosis); chronic health conditions; symptoms of temporomandibular joint (TMJ) dysfunction, children unable to cooperate with treatment and first permanent molar with signs and/or symptoms of pulp involvement or with orthodontic appliances will be excluded

Design outcomes

Primary

MeasureTime frame
The primary outcome will the success rate of the restorative treatment. We expect to find a success rate of the test treatment at least 20% higher than the control treatment. superiority of the test treatment Each treated tooth will be assessed by visual clinical examination and classified based on the criteria described below every 6 months until 36 months: Success: Satisfactory restoration/crown, no intervention needed (absence of marginal failure, breakdown, or wear; crown still present). Absence of signs and/or symptoms of pulpal pathology (abscess, fistula and/or espontaneous pain). Failure: Minor - Unsatisfactory restoration/crown represented by minor marginal failure, breakdown, or wear; loosing crown. Repair of the restoration/crown is needed. Absence of signs and/or symptoms of irreversible pulpal pathology (abscess, fistula and/or spontaneous pain). Intermediary - Unsatisfactory restoration represented by major marginal failure, breakdown, wear, or total lost (filling or crown). Replacement of the restoration is needed and/or signs and/or symptoms of pulpal complication are detected (abscess, fistula and/or espontaneous pain). Major - Unsatisfactory restoration represented by major marginal failure, breakdown, wear, or total lost (filling or crown) that it is impossible replacement the restoration. Signs and/or symptoms of pulpal complication are detected (abscess, fistula and/or espontaneous pain).

Secondary

MeasureTime frame
Time required for the treatment: The time required for the test and control treatments will be recorded with a chronometer and registered in minutes. For the test intervention (HT), two appointments will be necessary. In the first appointment, the chronometer will be initiated when the child is in the dental chair with his/her mouth open and the dentist has the orthodontic rubber ring in hands. When the orthodontic rubber ring is in place and the dentist says the child can close his/her mouth, the chronometer will be ended. In the second appointment, the chronometer will be initiated when the child is in the dental chair with his/her mouth open and the dentist has the probe to remove the orthodontic rubber ring in hands. When the crown is cemented, excess was removed, and the dentist says the child can close his/her mouth, the chronometer will be ended. For the control intervention (GIC), only one appointment is necessary. The chronometer will be initiated when the child is in the dental chair with his/her mouth open and the dentist has the dental mirror and hand excavator in hands. When the restoration is finished and the dentist says the child can close his/her mouth, the chronometer will be ended. ;Self-reported discomfort: The self-reported discomfort will be assessed using the visual analogue scale Wong-Baker FACES Pain Rating Scale. This is an ordinal six-point scale ranging from 0 to 5, and score 0 shows a smiling face, indicating no discomfort, whereas a score of 5 shows a crying and sad face, indicating great discomfort. Immediately after the end of treatment, when the child is out of treating room, a trained dental assistant will ask the child to point which face better depicts what he/she experienced during the treatment. For the HT group, this will be measured after each appointment. ;Temporomandibular joint (TMJ) disfunction: The 3Q/TMD will be used to evaluate symptoms of TMJ dysfunction. The evaluation will be done before treatment and every 6 months

Countries

Brazil

Contacts

Public ContactVera Soviero

Universidade do Estado do Rio de Janeiro

vera.soviero@uerj.br+552125877282

Outcome results

None listed

Source: REBEC (via WHO ICTRP)