Two Years Survival Rate of Class II ART Restorations in Primary Molars Using Two Ways to Avoid Saliva Contamination

Two Years Survival Rate of Class II ART Restorations in Primary Molars Using Either Rubber Dam or Cotton Rolls.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01924611

Enrollment

232

Registered

2013-08-16

Start date

2004-09-30

Completion date

2007-03-31

Last updated

2013-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

Dental caries, Atraumatic Restorative Technique

Brief summary

AIM: To evaluate influence of two methods to avoid saliva contamination on the survival rate of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both genders, were selected having one primary molar with a proximal dentine lesion. The children were randomly divided into two groups: a control group with class II ART restoration made using cotton rolls and an experimental group using rubber dam. The restorations were made and they were followed up every six months. After two years, the results were compilated and analyzed.

Detailed description

To evaluate influence of two methods to avoid saliva contamination on the survival rate of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both genders, were selected having one primary molar with a proximal dentine lesion. The children were randomly divided into two groups: a control group with class II ART restoration made using cotton rolls and an experimental group using rubber dam. The restorations were made and they were followed up every six months. After two years, the results were compilated and analyzed.

Interventions

PROCEDUREAtraumatic Restorative Technique using cotton rolls

Atraumatic Restorative Technique using cotton rolls.

PROCEDUREAtraumatic Restorative Technique

Atraumatic Restorative Technique is typically used in Minimally invasive Dentistry. This restoration technique is made using only hand instruments and is possible to be carried out in children in schools. This particular time, the isolation of the surgical/tooth area was made using rubber dam as saliva barrier.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 7 Years

Inclusion criteria

* Children of both genders enrolled in school, * Children aged between 6 and 7 years, * having cavity with access to ART hand instruments, * cavity with a mesio-distal maximum dimension of 1mm and a buccal-lingual maximum dimension of 2mm length, measured on the oclusal surface, * proximal surface of the adjacent tooth should be unimpaired, without visible lesions,

Exclusion criteria

* Cavity lesions having pulpal involvement, swelling, fistula or pain were not included in the study, * Children out of the age range,

Design outcomes

Primary

Measure	Time frame	Description
Number of teeth with fractured restorations.	2 years	The teeth were assessed every 6 months for a period of 2 years and they were graded according to restoration fractures.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026