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Impact of Atraumatic Restorative Treatment and Oral Health Promotion on Psychological and Salivary Aspects of Children

U

University of Campinas, Brazil

Status

Completed

Conditions

Dental Caries

Treatments

Other: Oral health educational strategy
Procedure: Atraumatic Restorative Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03100773
CJK-2014-ART

Details and patient eligibility

About

This study evaluated the impact of atraumatic restorative treatment associated with oral health educational strategy on dental anxiety, oral health-related quality of life and salivary biochemical and microbiological characteristics of Brazilian schoolchildren.

Full description

Children aged six- to eight years-old, both gender, were selected from public schools of Piracicaba, SP, Brazil, and were divided in three groups: caries-free children (control group, GC), children with at least one primary molar with dentin caries lesion submitted to oral health educational strategy followed by ART (GS+ART), and the other group was directly submitted to ART (GART). Oral hygiene was assessed by the presence of biofilm and gingivitis in buccal surfaces of primary and/or permanent upper incisors. Oral health educational strategy consisted of four consecutive sessions (once a week) about etiological factors of caries (using visual aids), oral hygiene instructions (using models), supervised toothbrushing and explanation of ART (indications and stages). ART was performed using hand instruments for opening and cleaning the cavities and a high-viscosity glass-ionomer for restoration. Dental anxiety was assessed by measuring the cognitive (modified Venham Picture Test, m-VPT), behavioral (modified Venham Anxiety Scale, m-VAS) and physiological (heart rate, HR; salivary cortisol and alpha-amylase, SC and SAA) aspects in the following days and moments: D1 - baseline, a day preceding ART (SC and SAA); D2 - day of treatment, before strategy (m-VPT), before ART (m-VPT, HR, SC, SAA), during the explanation of procedure (HR, m-VAS), at the moment of deepest excavation (HR, m-VAS), at the moment the restoration was applied (HR, m-VAS), after ART (m-VPT, HR, SC, SAA). The following variables were evaluated in three moments: T1 - baseline, T2 - one week after strategy (for both GC and GART) and T3 - one month after the strategy or ART for GC and GART, respectively. Oral health-related quality of life was assessed using Brazilian short version of the Child Perceptions Questionnaire (16-CPQ8-10) with 16 items. Salivary flow rate was estimated by chewing 0.3g of an inert and tasteless material, for approximately 70 cycles/min and spitting all the saliva produced for five minutes into a cooled tube. Salivary pH was determined immediately after collection, using a portable pH-meter. Salivary buffer capacity was performed by adding 1.5 ml of HCl/5 mM to a tube containing 0.5 mL of stimulated saliva. For detection and quantification of S. mutans, the microbial DNA in unstimulated saliva samples was isolated and subjected to quantitative PCR reactions (qPCR).

Enrollment

78 patients

Sex

All

Ages

6 to 8 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • caries-free;
  • presence of at least one primary molar with dentin caries lesion (without painful symptoms, mobility and abscess).

Exclusion criteria

  • indication for tooth extraction;
  • presence of fistula;
  • abscess or spontaneous toothache;
  • insufficient tooth structure to support restoration;
  • current use of medications that could interfere with the central nervous system;
  • inappropriate behavior and/or refusal to participate.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

78 participants in 3 patient groups

Group control
Experimental group
Description:
Caries-free children submitted to four consecutive sessions of oral health educational strategy (once a week).
Treatment:
Other: Oral health educational strategy
Group of strategy + ART
Experimental group
Description:
Children with at least one decayed primary molar in dentin submitted to four consecutive sessions of oral health educational strategy (once a week) followed by Atraumatic Restorative Treatment (ART)
Treatment:
Procedure: Atraumatic Restorative Treatment
Other: Oral health educational strategy
Group of ART
Experimental group
Description:
Children with at least one decayed primary molar in dentin submitted to Atraumatic Restorative Treatment (ART)
Treatment:
Procedure: Atraumatic Restorative Treatment

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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