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Completed

NCT Number: NCT03100773

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

Primary outcomes

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

    Time frame: 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).

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

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

    Time frame: 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).

    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.

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

    Time frame: 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).

    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.

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

    Time frame: 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).

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

  5. Change in salivary physicochemical properties.

    Time frame: 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).

    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.

  6. Change in salivary microbiological properties.

    Time frame: 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).

    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).

Secondary outcomes

  1. Change in oral hygiene.

    Time frame: 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).

    Oral hygiene was assessed by the presence of biofilm and gingivitis in buccal surfaces of primary and/or permanent upper incisors (presence/absence; frequencies) (in scores).

  2. Change in oral health-related quality of life.

    Time frame: 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).

    Oral health-related quality of life was assessed using the Brazilian short version of the Child Perceptions Questionnaire (16-CPQ8-10), with 16 items (in scores).

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 4, 2017
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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