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Restorations evaluation in primary teeth

Adhesive restorations in primary molars - a longitudinal clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7d67hw
Enrollment
Unknown
Registered
2016-02-26
Start date
2010-12-01
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

carious lesions

Interventions

Group I control: 45 participants with deciduous molar tooth restored with adhesive and composite resin system
Group II test: 45 participants with deciduous molar tooth restored cement glass ionomer resin
Group III test: 45 participants with deciduous molar tooth restored with self-etching adhesive system and composite resin P90 (3M) Each patient may have included in the search 1 to 8 teeth. We include
Procedure/surgery
E06.323.428

Sponsors

Faculdade de Odontologia da Universidade Federal do Rio Grande do Sul
Lead Sponsor
Centro Universitário Franciscano
Collaborator
Fundação de Amparo a Pesquisa do Estado do Rio Grande do Sul
Collaborator

Eligibility

Age
6 Years to 11 Years

Inclusion criteria

Inclusion criteria: Patients aged 6 to 11 years; both genres; bearing teeth with active caries lesions limited to deep dentin / occluded proximal-occlusal surface of primary molars; absence of clinical diagnosis of pulp exposure, fistula, edema of the periodontal tissues and tooth mobility incompatible with stage of root resorption; absence of clinical symptoms of irreversible pulpitis; such as spontaneous pain or pressure sensitivity; the extent of the carious lesion should be such that complete / incomplete removal of decayed tissue not run the risk of pulp exposure as determined by clinical and radiographic evaluation; absence of radiolucencies in the inter-radicular regions (bifurcation) or periapical or thickening of the periodontal spaces which indicate the presence of irreversible pulp pathologies or necrosis; absence of internal or external root resorption.

Exclusion criteria

Exclusion criteria: Pulp exposure during cavity preparation procedure

Design outcomes

Primary

MeasureTime frame
Failure rate of restorations in 18 months, measured by the modified USPHS criteria (United States Public Health Service). A difference of 25% between groups was estimated.;Failure rate of restorations in 18 months, measured by the modified USPHS criteria (United States Public Health Service). A difference of 25% between groups was estimated. A 15.4% failure rate was observed in Group I, 13.2% in group II, and 9.5 in group III, with no statistical difference between the groups.

Secondary

MeasureTime frame
Secondary outcomes aren´t expected.;Secondary outcomes aren´t expected.

Countries

Brazil

Contacts

Public ContactLuciano Casagrande

Faculdade de Odontologia da Universidade Federal do Rio Grande do Sul

luciano.casagrande@hotmail.com55(51)33085010

Outcome results

None listed

Source: REBEC (via WHO ICTRP)