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

NCT03657862 | Unknown DMC

• 1 other identifier: UW 17-180
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Restoration Failure of Marginal Integrity

Outcome Measures

Primary Outcomes (1)

• success of the ART restorations

  A restoration is classified as success when it is retained on the tooth without major defects or wear and has no associated active caries.

  24 months

Secondary Outcomes (2)

• 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

  24 months

• oral health related quality of life of the child as assessed by the Early Childhood Oral Health Impact Scale

  24 months

Study Arms (2)

SDF treated

EXPERIMENTAL

application of 38% silver diamine fluoride solution

Device: application of 38% silver diamine fluoride solution

Placebo

PLACEBO COMPARATOR

application of a placebo (tonic water)

Other: application of a placebo (tonic water)

Interventions

application of 38% silver diamine fluoride solution DEVICE

SDF solution was painted onto the surface of the carious lesion of the tooth

SDF treated

application of a placebo (tonic water) OTHER

tonic water was painted onto the surface of the carious lesion of the tooth

Placebo

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

Related Publications (3)

• Holmgren CJ, Roux D, Domejean S. Minimal intervention dentistry: part 5. Atraumatic restorative treatment (ART)--a minimum intervention and minimally invasive approach for the management of dental caries. Br Dent J. 2013 Jan;214(1):11-8. doi: 10.1038/sj.bdj.2012.1175.

  PMID: 23306489 BACKGROUND

• Lo EC, Holmgren CJ, Hu D, van Palenstein Helderman W. Six-year follow up of atraumatic restorative treatment restorations placed in Chinese school children. Community Dent Oral Epidemiol. 2007 Oct;35(5):387-92. doi: 10.1111/j.1600-0528.2006.00342.x.

  PMID: 17822487 BACKGROUND

• Lee GH, McGrath C, Yiu CK, King NM. Translation and validation of a Chinese language version of the Early Childhood Oral Health Impact Scale (ECOHIS). Int J Paediatr Dent. 2009 Nov;19(6):399-405. doi: 10.1111/j.1365-263X.2009.01000.x.

  PMID: 19811551 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 5, 2018
• Study Start: September 15, 2017
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: September 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)