A clinical study to assess the durability dental restorations made with bioactive restorative materials: a randomized clinical trial

Longevity of class II restorations performed with bioactive restorative materials: a randomized clinical trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-2hqhdp

Enrollment

Unknown

Registered

2018-11-06

Start date

2018-08-15

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

In total, 120 participants with class II carious lesions will be divided into three groups of 40 patients each, restorations will be done according to the manufacturer's instructions of each restorati

Procedure/surgery

E06.323.428

Eligibility

Age

12 Years to 50 Years

Inclusion criteria

Inclusion criteria: Patients 12 to 50 years old able to provide valid information; who require at least one class II dental restoration due to active carious lesion or exchange for poor permanent tooth restoration; the tooth selected to receive the restoration must have an antagonist and adjacent tooth; without excessive tooth wear; without evident temporomandibular disorders.

Exclusion criteria

Exclusion criteria: Start orthodontics during the course of the research; present allergy to any material used in the research.

Design outcomes

Primary

Measure	Time frame
Retention failure of composite restorations will be evaluated by clinical assessment (visual inspection), considering a variation of at least 5% in the measurements after polishing, 6, 12 and 24 months;The presence of the fracture of the restoration will be evaluated by clinical assessment (visual inspection), considering a variation of at least 5% in the measurements after polishing, 6, 12 and 24 months	—

Measure

Time frame

Retention failure of composite restorations will be evaluated by clinical assessment (visual inspection), considering a variation of at least 5% in the measurements after polishing, 6, 12 and 24 months;The presence of the fracture of the restoration will be evaluated by clinical assessment (visual inspection), considering a variation of at least 5% in the measurements after polishing, 6, 12 and 24 months

—

Secondary

Measure	Time frame
The presence of the Marginal discoloration of the restoration will be evaluated by clinical assessment (visual inspection), considering a variation of at least 5% in the measurements after polishing, 6, 12 and 24 months ;The presence of the recurrence caries will be evaluated by clinical assessment (visual inspection), considering a variation of at least 5% in the measurements after polishing, 6, 12 and 24 months	—

Measure

Time frame

The presence of the Marginal discoloration of the restoration will be evaluated by clinical assessment (visual inspection), considering a variation of at least 5% in the measurements after polishing, 6, 12 and 24 months ;The presence of the recurrence caries will be evaluated by clinical assessment (visual inspection), considering a variation of at least 5% in the measurements after polishing, 6, 12 and 24 months

—

Countries

Brazil

Contacts

Public ContactTaciana Caneppele

Instituto de Ciência e Tecnologia - Universidade Estadual Paulista

taciana@ict.unesp.br+55-012-39479304

Outcome results

None listed

Source: REBEC (via WHO ICTRP)