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The effect of two types of restorations on deciduous teeth in babies

Effectiveness of restorations in resin-modified glass ionomer cement and bulk-fill resin in deciduous molars of babies: randomized clinical trial protocol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4hqvqr
Enrollment
Unknown
Registered
2020-03-10
Start date
2020-05-01
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 caries

Interventions

All restorative procedures will be performed after prophylaxis. Local anesthesia (Lidocaine 2% with epinephrine hydrochloride 1: 100,000 IU) will be used to reduce discomfort due to staple placement f
Procedure/surgery
E06.323.428

Sponsors

Universidade Federal de Minas Gerais
Lead Sponsor
Universidade Federal de Minas Gerais
Collaborator

Eligibility

Age
18 Months to 36 Months

Inclusion criteria

Inclusion criteria: Children physically classified according to the American Society of Anesthesiology (ASA) at level I (healthy); who are undergoing treatment or waiting list for care in pediatric dentistry clinics from FAO-UFMG; Between 18 up to 36 months of age; who present at least two cavitated caries lesions restricted to the occlusal face in radiographically detectable primary molars in dentin, characterized as medium and deep lesions (SCHWENDICKE et al., 2016) being one lesion in each left and right); Only children whose parents/guardians sign the consent form.

Exclusion criteria

Exclusion criteria: Children with deep caries lesions affecting the pulp chamber or at risk of exposure; who have fistula or abscess; pulp exposure; history of spontaneous pain or tooth mobility associated with decayed teeth; molar teeth with other restorations, enamel defects, or endodontic treatment that have carious lesions associated with an existing restoration or that do not stabilize the clamp for absolute isolation

Design outcomes

Primary

MeasureTime frame
To assess the survival of restorations by visual inspection using the criteria of ROELEVELD et al. (2006) after 1, 6, 12, 18 and 24 months of treatment, being considered success intact restorations and those with small failures, which receive scores from 00 to 10, and being considered failures the restored teeth that receive scores between 11 and 40.

Secondary

MeasureTime frame
To assess the dental sensitivity before and after treatments using the DDQ-B questionnaire (VERSLOOT et al., 2006; DAHER et al., 2014), which will be applied to the children's parents/guardians.;To evaluate the cost-effectiveness of restorations, using the cost-effectiveness ratio method, based on the calculation of the costs of implementing the different restorative treatments and the assessment of the survival rate of the restorations.

Countries

Brazil

Contacts

Public ContactPaulo Martins-Júnior

Universidade Federal de Minas Gerais

pauloa-martinsjunior@ufmg.br+55-31-34092496

Outcome results

None listed

Source: REBEC (via WHO ICTRP)