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

Primary Purpose

Dental Caries

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Atraumatic Restorative Technique using cotton rolls

Atraumatic Restorative Technique

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Dental caries, Atraumatic Restorative Technique

Eligibility Criteria

6 Years - 7 Years (Child)All Sexes

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,

Sites / Locations

Universidade Federal da Paraíba

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

Atraumatic Restorative Technique using cotton rolls.

Atraumatic Restorative Technique using rubber dam.

Outcomes

Primary Outcome Measures

Number of teeth with fractured restorations.

The teeth were assessed every 6 months for a period of 2 years and they were graded according to restoration fractures.

Secondary Outcome Measures

Full Information

NCT ID

NCT01924611

First Posted

August 13, 2013

Last Updated

August 15, 2013

Sponsor

Federal University of Paraíba

Collaborators

Academic Centre for Dentistry in Amsterdam

1. Study Identification

Unique Protocol Identification Number

NCT01924611

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

March 2007 (Actual)

Study Completion Date

March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of Paraíba

Collaborators

Academic Centre for Dentistry in Amsterdam

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

Keywords

Dental caries, Atraumatic Restorative Technique

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

232 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Atraumatic Restorative Technique using cotton rolls.

Arm Title

Experimental Group

Arm Type

Experimental

Arm Description

Atraumatic Restorative Technique using rubber dam.

Intervention Type

Procedure

Intervention Name(s)

Atraumatic Restorative Technique using cotton rolls

Other Intervention Name(s)

Atraumatic Restorative Technique

Intervention Description

Atraumatic Restorative Technique using cotton rolls.

Intervention Type

Procedure

Intervention Name(s)

Atraumatic Restorative Technique

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of teeth with fractured restorations.

Description

The teeth were assessed every 6 months for a period of 2 years and they were graded according to restoration fractures.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

7 Years

Eligibility Criteria

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,

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Evert van Amerongen, DDS, PhD, Professor

Organizational Affiliation

Academic Centre for Dentistry in Amsterdam

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Fabio Correia Sampaio, DDS PhD PostDoc

Organizational Affiliation

UFPB

Official's Role

Study Director

Facility Information:

Facility Name

Universidade Federal da Paraíba

City

João Pessoa

State/Province

Paraíba

ZIP/Postal Code

58000-000

Country

Brazil

12. IPD Sharing Statement

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

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