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

NCT01924611 | Completed

• 1 other identifier: CEP 134/04
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

Dental caries; Atraumatic Restorative Technique

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Atraumatic Restorative Technique using cotton rolls.

Procedure: Atraumatic Restorative Technique using cotton rolls

Experimental Group

EXPERIMENTAL

Atraumatic Restorative Technique using rubber dam.

Procedure: Atraumatic Restorative Technique

Interventions

Atraumatic Restorative Technique using cotton rolls PROCEDURE

Atraumatic Restorative Technique using cotton rolls.

Also known as: Atraumatic Restorative Technique

Control Group

Atraumatic Restorative Technique PROCEDURE

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.

Experimental Group

Eligibility Criteria

• Age: 6 Years - 7 Years
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• 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,

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Paraíba: lead
• Academic Centre for Dentistry in Amsterdam: collaborator

Study Sites (1)

Universidade Federal da Paraíba

João Pessoa, Paraíba, 58000-000, Brazil

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Evert van Amerongen, DDS, PhD, Professor

  Academic Centre for Dentistry in Amsterdam

  STUDY DIRECTOR

• Fabio Correia Sampaio, DDS PhD PostDoc

  UFPB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 16, 2013
• Study Start: September 1, 2004
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: August 16, 2013

Record last verified: 2013-08

Locations

BR (1)