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

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oral health educational strategy
Atraumatic Restorative Treatment
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring alpha-amylases, child, cortisol, dental anxiety, dental atraumatic restorative treatment, health education, microbiota, oral hygiene, quality of life, saliva

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Group control

    Group of strategy + ART

    Group of ART

    Arm Description

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

    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)

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

    Outcomes

    Primary Outcome Measures

    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).
    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.
    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.
    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).
    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.
    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).

    Secondary Outcome Measures

    Change in oral hygiene.
    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).
    Change in oral health-related quality of life.
    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).

    Full Information

    First Posted
    January 22, 2016
    Last Updated
    March 28, 2017
    Sponsor
    University of Campinas, Brazil
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03100773
    Brief Title
    Impact of Atraumatic Restorative Treatment and Oral Health Promotion on Psychological and Salivary Aspects of Children
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Campinas, Brazil
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries
    Keywords
    alpha-amylases, child, cortisol, dental anxiety, dental atraumatic restorative treatment, health education, microbiota, oral hygiene, quality of life, saliva

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    78 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group control
    Arm Type
    Experimental
    Arm Description
    Caries-free children submitted to four consecutive sessions of oral health educational strategy (once a week).
    Arm Title
    Group of strategy + ART
    Arm Type
    Experimental
    Arm 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)
    Arm Title
    Group of ART
    Arm Type
    Experimental
    Arm Description
    Children with at least one decayed primary molar in dentin submitted to Atraumatic Restorative Treatment (ART)
    Intervention Type
    Other
    Intervention Name(s)
    Oral health educational strategy
    Intervention Description
    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).
    Intervention Type
    Procedure
    Intervention Name(s)
    Atraumatic Restorative Treatment
    Intervention Description
    Atraumatic Restorative Treatment was performed using hand instruments for opening and cleaning the cavities and a high-viscosity glass-ionomer for restoration.
    Primary Outcome Measure Information:
    Title
    Change in dental anxiety assessed by measuring the cognitive and behavioral aspects.
    Description
    The cognitive and behavioral aspects were assessed by modified Venham Picture Test (m-VPT) and modified Venham Anxiety Scale (m-VAS), respectively (scores).
    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).
    Title
    Change in dental anxiety assessed by measuring the salivary biomarkers.
    Description
    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.
    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).
    Title
    Change in dental anxiety assessed by measuring the salivary biomarkers.
    Description
    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.
    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).
    Title
    Change in dental anxiety assessed by measuring the physiological aspect.
    Description
    The physiological aspect was assessed by heart rate (HR, in beats per minute, bpm) using a digital monitor (S625x, Polar, Finland).
    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).
    Title
    Change in salivary physicochemical properties.
    Description
    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.
    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).
    Title
    Change in salivary microbiological properties.
    Description
    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).
    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).
    Secondary Outcome Measure Information:
    Title
    Change in oral hygiene.
    Description
    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).
    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).
    Title
    Change in oral health-related quality of life.
    Description
    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).
    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).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Taís S Barbosa, PhD
    Organizational Affiliation
    University of Campinas, Brazil
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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