Skip to content

Does the method of tooth isolation influence the longevity of restorations?

Does ruber dam isolation increases the longevity of restorations of primary molars? A randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8hcg2c
Enrollment
Unknown
Registered
2020-01-06
Start date
2018-12-01
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

Dental Caries

Interventions

All participants and their guardians will receive flossing hygiene instruction, fluoridated toothpaste and dietary advice. Patients will receive brush and floss prophylaxis before receiving treatment.
E06.323.428

Sponsors

Universidade Federal do Rio Grande do Sul
Lead Sponsor
Universidade Federal do Rio Grande do Sul
Collaborator

Eligibility

Age
3 Years to 9 Years

Inclusion criteria

Inclusion criteria: Patients aged 3 to 9 years old who have at least one class I or II caries lesion in deciduous molars; 198 teeth; who radiographically have at least two thirds root, and lesions D1 and D2, where restorative treatment is indicated. E1 Radiolucidity in the outer half of enamel; E2 Radiolucidity in the inner half of enamel; D1 Radiolucidity in the external third of dentin; D2 Radiolucidity in the middle third of dentin; D3 Radiolucidity in the internal third of dentin.

Exclusion criteria

Exclusion criteria: spontaneous pain; fistula; mobility not compatible with the period of root resorption; advanced rhizolysis more than 2/3 of root resorption; participants who were included in the course were not included in the study.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: Survival rate of occlusal and occlusoproximal restorations performed with resin modified glass ionomer cement in primary molars under absolute and relative isolation. ;Found outcome 1: There was no significant difference in survival rates between groups (p=0.17). Older age (HR = 2.81 [95% CI: 1.47-5.44]) and a higher rate of gingival bleeding (HR = 0.47 [95% CI: 0.23-0.99]) were associated with restorative failures. No patient had painful symptoms, pulp outcomes.;Expected outcome 2: Arrestment of occlusal and occlusoproximal lesions restored under relative and absolute isolation. ;Found outcome 2: No patient had radiographic changes compatible with lesion progression.

Secondary

MeasureTime frame
Found outcome 1: The percentage of patients who reported having had no discomfort or little discomfort after the restorative procedure was 86.1%. There was no statistically significant difference between the groups regarding the level of discomfort according to the Chi-square test (p=0.745). There was no statistically significant difference between groups regarding the number of restored surfaces (p=0.404), side of the arch (p=0.961), type of arch (p=0.108) and type of molar restored (p=0.708). ;Expected outcome 1: Children discomfort during restorative treatment.

Countries

Brazil

Contacts

Public ContactJonas Rodrigues

Universidade Federal do Rio Grande do Sul

jorodrigues@ufrgs.br+555133085176

Outcome results

None listed

Source: REBEC (via WHO ICTRP)