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Outcomes of Restoring Untreated and SDF-treated Dentine Caries Lesions in Primary Teeth of Preschool Children

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ClinicalTrials.gov Identifier: NCT03657862
Recruitment Status : Active, not recruiting
First Posted : September 5, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Brief Summary:

The primary objective of this proposed clinical study is to compare the success rates of ART restorations placed in untreated and SDF-treated dentine caries lesions in primary teeth. The secondary objective is to describe the change in parents' satisfaction with the aesthetics of their child's teeth and the change in oral health-related quality of life of preschool children before and after placement of ART restorations.

The study population is preschool children attending kindergartens in different districts in Hong Kong. Children attending grades 1 or 2 in nine kindergartens were invited to receive a free dental examination and had their decayed primary teeth restored, if possible, in the kindergarten by dentists. Parental informed consent was obtained before the dental examination and treatment. Half of the children with decayed primary teeth needing restorations were assigned randomly to receive SDF treatment around 10 weeks before receiving the restoration. The restored teeth were re-examined every 6 months for 24 months to assess the treatment outcome. Parents of the study children were asked to complete a questionnaire at baseline, 6 months and 24 months so as to obtain data on their satisfaction with the aesthetics of their child's teeth and the oral health-related quality of life of the study children.


Condition or disease Intervention/treatment Phase
Dental Restoration Failure of Marginal Integrity Device: application of 38% silver diamine fluoride solution Other: application of a placebo (tonic water) Not Applicable

Detailed Description:

The study population of this proposed study is Hong Kong preschool children. Children attending grade 1 or 2 in nine selected kindergartens were invited to join this study. An invitation letter with information on the purpose and procedures of the study was sent to the parents of the children through the kindergarten. The parents were asked to give written consent for allowing their child to receive a free oral examination and ART restorations, if indicated for treating the decayed primary teeth in their child's mouth, provided by dentists in the kindergarten. Parental consent were obtained before inclusion of a child in this study.

Cavitated caries lesions in the primary teeth of the study children were restored following the ART procedures (Holmgren et al., 2013). The instruments used were LED illuminated dental mirror, sickle probe, tweezers, hatchet, excavators and flat plastic. The dental restorative material used was a high-strength chemical-cured glass ionomer (Ketac-molar, 3M ESPE, Germany).

At the baseline, all children with parental consent were clinically examined in the kindergarten. Disposable dental mirror attached to a handle with an intra-oral LED light and a ball-ended probe was used. The status of each tooth was recorded. Children who had at least one decayed primary tooth with a cavity into dentine were included into the study. All decayed teeth in the children were restored, except those with inadequate access and those with signs of pulpal pathology. The decayed teeth in half of the children received topical application of a SDF solution (Saforide, Toyo Chemical, Japan), through simple random allocation on a child basis using random numbers, around 10 weeks before receiving the restoration. The time used for placement of each restoration was recorded to the nearest minute.

The children were examined at 6 and will be examined at 12, 18 and 24 months after placement of ART restorations by calibrated examiners who were not involved in the placement of the restorations. The same instruments used in the baseline examination were used in the follow-up examinations. The status of the restorations and restored teeth were assessed and recorded using codes and criteria commonly adopted in previous clinical studies of ART restorations (Lo et al., 2007).

At baseline, information on the children's oral hygiene practice, snacking habit, oral health related quality of life, and parental satisfaction with the appearance of their child's teeth was collected by a self-completed questionnaire. A validated tool for measuring oral health related quality of life of preschool children in Hong Kong, Chinese version of Early Childhood Oral Health Impact Scale (ECOHIS), was used (Lee et al., 2009). The same measurement tool was used at the 6-month and will be used at 24-month follow-up.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

There are 2 groups of study participants in this study.

Children with decayed teeth were randomly allocated into either Group 1 (receive topical application of a SDF solution) or Group 2 (placebo) using random numbers, around 10 weeks before receiving dental restoration.

Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:

The participants (children) did not know their group allocation because a placebo was applied if SDF was not applied.

The care providers (operator) and the examiners (outcome assessor) were not informed of the children's group allocation.

Primary Purpose: Treatment
Official Title: Comparative Study on the Outcomes of Restoring Untreated and SDF-treated Dentine Caries Lesions in Primary Teeth of Preschool Children
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health
Drug Information available for: Fluoride

Arm Intervention/treatment
Experimental: SDF treated
application of 38% silver diamine fluoride solution
Device: application of 38% silver diamine fluoride solution
SDF solution was painted onto the surface of the carious lesion of the tooth

Placebo Comparator: Placebo
application of a placebo (tonic water)
Other: application of a placebo (tonic water)
tonic water was painted onto the surface of the carious lesion of the tooth




Primary Outcome Measures :
  1. success of the ART restorations [ Time Frame: 24 months ]
    A restoration is classified as success when it is retained on the tooth without major defects or wear and has no associated active caries.


Secondary Outcome Measures :
  1. parental satisfaction with aesthetics of their child's teeth as reported in the parent's answer to a question on their satisfaction with the appearance of their child's teeth [ Time Frame: 24 months ]
    parent's answer to a question on their satisfaction with the appearance of their child's teeth. The question is "How satisfied are you with the overall appearance of your child's teeth?" The answer option is a 5-point scale with 5 being very satisfied, 4 being satisfied, 3 being neutral, 2 being dissatisfied, and 1 being very dissatisfied.

  2. oral health related quality of life of the child as assessed by the Early Childhood Oral Health Impact Scale [ Time Frame: 24 months ]
    parents' answers to a series of questions in the Early Childhood Oral Health Impact Scale. This scale contains 13 self-completed questions on various aspects of the impact of child oral health on the daily activities of the child or the family. The answer in each question is on a 5-point scale with 0 being no impact and 4 being great impact. The scale score is the summation of the answer scores to the 13, which can range from 0 to 52. The higher the scale score, the more impacts of oral health on life activities and thus lower quality of life.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • generally healthy children who had at least one decayed primary tooth with a cavity into dentine

Exclusion Criteria:

  • children with serious systemic diseases/conditions or who were uncooperative during treatment
  • teeth with signs of pulpal pathology such as having an abscess or discoloured
  • caries lesions which did not have adequate access for hand instruments to prepare the cavity for a filling and those that were treated with SDF solution but with most parts still being active

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657862


Locations
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China
The University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
  Study Documents (Full-Text)

Documents provided by The University of Hong Kong:
Study Protocol  [PDF] July 27, 2017


Publications:
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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03657862     History of Changes
Other Study ID Numbers: UW 17-180
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pharmaceutical Solutions
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs