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

NCT03100773 | Completed DMC

• 1 other identifier: CJK-2014-ART
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dental Caries

Keywords

alpha-amylases; child; cortisol; dental anxiety; dental atraumatic restorative treatment; health education; microbiota; oral hygiene; quality of life; saliva

Outcome Measures

Primary Outcomes (6)

• Change in dental anxiety assessed by measuring the cognitive and behavioral aspects.

  The cognitive and behavioral aspects were assessed by modified Venham Picture Test (m-VPT) and modified Venham Anxiety Scale (m-VAS), respectively (scores).

  T1: one day preceding the oral health educational strategies (GS+ART) (m-VPT); T2: during ART procedure (GS+ART and GART) (m-VAS) and immediately after ART (GS+ART and GART) (m-VPT); T3: 10 minutes after ART (GS+ART and GART) (m-VPT).

• Change in dental anxiety assessed by measuring the salivary biomarkers.

  The hormonal biomarker was assessed by saliva collection for cortisol - sC (in microgram per using commercially available kit (Salimetrics, State College, PA, USA) according to the manufacturer's directions.

  T1: 30 min preceding the ART (GART) and one day preceding OHES (GS+ART); T2: immediately after ART (GS+ART/GART); T3: 10 min after ART (GS+ART/GART).

• Change in dental anxiety assessed by measuring the salivary biomarkers.

  The enzymatic biomarker was assessed by saliva collection for alpha-amylase - sAA (in international units per milliliter of saliva - U/ml) using commercially available kit (Salimetrics, State College, PA, USA) according to the manufacturer's directions.

  T1: 30 min preceding the ART (GART) and one day preceding OHES (GS+ART); T2: immediately after ART (GS+ART/GART); T3: 10 min after ART (GS+ART/GART).

• Change in dental anxiety assessed by measuring the physiological aspect.

  The physiological aspect was assessed by heart rate (HR, in beats per minute, bpm) using a digital monitor (S625x, Polar, Finland).

  T1: 30 min preceding the ART (GART) and one day preceding OHES (GS+ART); T2: during ART procedure (GS+ART/GART) and immediately after ART (GS+ART/GART); T3: 10 min after ART (GS+ART/GART).

• Change in salivary physicochemical properties.

  The physicochemical properties of saliva were measured by flow rate (mL/min), pH and buffer capacity. Salivary stimulated and unstimulated flow rates were estimated as the volume of saliva secreted per min (mL/min). Salivary pH was determined immediately after collection in stimulated saliva, using a portable pH-meter (Orion 3 Star Benchtop, Thermo Electron Corporation, USA). Buffer capacity was performed by adding 1.5 ml of 5 mM HCl to a tube containing 0.5 mL of stimulated saliva and further determination of salivary pH.

  T1: 1 week before oral health strategy (GC and GS+ART); T2: 1 week after oral health strategy (GC and GS+ART); T3: 1 month after oral health strategy (GC) and 1 month after ART (GS+ART).

• Change in salivary microbiological properties.

  The microbiological characteristics of saliva were measured by total bacteria and S. mutans levels. The detection and quantification of S. mutans and total bacteria, the microbial DNA in unstimulated saliva samples was isolated and subjected to quantitative PCR reactions (qPCR).

  T1: 1 week before oral health strategy (GC and GS+ART); T2: 1 week after oral health strategy (GC and GS+ART); T3: 1 month after oral health strategy (GC) and 1 month after ART (GS+ART).

Secondary Outcomes (2)

• Change in oral hygiene.

  T1 : 1 week before oral health strategy (GC and GS+ART) and 30 min before ART (GART); T2: 1 week after oral health strategy (GC and GS+ART); T3: 1 week after ART (GART and GS+ART); T4: 1 month after ART (GART and GS+ART).

• Change in oral health-related quality of life.

  T1: 1 week before oral health strategy (GC and GS+ART) and 30 min before ART (GART); T2: 1 week after oral health strategy (GC and GS+ART); T3: 1 week after ART (GART and GS+ART); T4: 1 month after ART (GART and GS+ART).

Study Arms (3)

Group control

EXPERIMENTAL

Caries-free children submitted to four consecutive sessions of oral health educational strategy (once a week).

Other: Oral health educational strategy

Group of strategy + ART

EXPERIMENTAL

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)

Other: Oral health educational strategy; Procedure: Atraumatic Restorative Treatment

Group of ART

EXPERIMENTAL

Children with at least one decayed primary molar in dentin submitted to Atraumatic Restorative Treatment (ART)

Procedure: Atraumatic Restorative Treatment

Interventions

Oral health educational strategy OTHER

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 atraumatic restorative treatment (indications and stages).

Group control; Group of strategy + ART

Atraumatic Restorative Treatment PROCEDURE

Atraumatic Restorative Treatment was performed using hand instruments for opening and cleaning the cavities and a high-viscosity glass-ionomer for restoration.

Group of ART; Group of strategy + ART

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

MeSH Terms

Conditions

Dental Caries; Health Education

Interventions

Dental Atraumatic Restorative Treatment

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Taís S Barbosa, PhD

  University of Campinas, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: April 4, 2017
• Study Start: January 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 4, 2017

Record last verified: 2017-03