Dental Restoration Failure of Marginal IntegrityNCT03657862
Outcomes of Restoring Untreated and SDF-treated Dentine Caries Lesions in Primary Teeth of Preschool Children
A study testing application of 38% silver diamine fluoride solution in people with Dental Restoration Failure of Marginal Integrity, run by The University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration Failure of Marginal Integrity
- What is being tested?
- application of 38% silver diamine fluoride solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2017to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- generally healthy children who had at least one decayed primary tooth with a cavity into dentine
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study on the Outcomes of Restoring Untreated and SDF-treated Dentine Caries Lesions in Primary Teeth of Preschool Children
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.
Read the 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.
- Being tested
- application of 38% silver diamine fluoride solution, application of a placebo (tonic water)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of 38% silver diamine fluoride solutionDevice
SDF solution was painted onto the surface of the carious lesion of the tooth
application of a placebo (tonic water)Other
tonic water was painted onto the surface of the carious lesion of the tooth
| Study group | Role | What they receive |
|---|---|---|
| SDF treated | Experimental | application of 38% silver diamine fluoride solution Receives: Device: application of 38% silver diamine fluoride solution |
| Placebo | Placebo comparator | application of a placebo (tonic water) Receives: Other: application of a placebo (tonic water) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 24 months
oral health related quality of life of the child as assessed by the Early Childhood Oral Health Impact Scale
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start15 Sep 2017
- Primary completion31 Jan 2020 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental Restoration Failure of Marginal IntegrityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657862
- Sponsor's protocol ID
- UW 17-180
- Status last verified
- Sep 2018
- First submitted
- 29 Aug 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23306489Lo 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.
PubMed 17822487Lee 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.
PubMed 19811551
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Outcomes of Restoring Untreated and SDF-treated Dentine Caries Lesions in Primary Teeth of Preschool Children
- ClinicalTrials.gov ID
- NCT03657862
- Acronym / sponsor ID
- UW 17-180
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SDF treated | Experimental | Device: application of 38% silver diamine fluoride solutionapplication of 38% silver diamine fluoride solution |
| Placebo | Placebo comparator | Other: application of a placebo (tonic water)application of a placebo (tonic water) |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- generally healthy children who had at least one decayed primary tooth with a cavity into dentine
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| application of 38% silver diamine fluoride solutionSDF solution was painted onto the surface of the carious lesion of the tooth | Device | SDF treated |
| application of a placebo (tonic water)tonic water was painted onto the surface of the carious lesion of the tooth | Other | Placebo |
Primary outcome
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.
2 secondary outcomes
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
oral health related quality of life of the child as assessed by the Early Childhood Oral Health Impact Scale
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Background: PubMed 23306489Holmgren 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.
- Background: PubMed 17822487Lo 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.
- Background: PubMed 19811551Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application of 38% silver diamine fluoride solution in people with Dental Restoration Failure of Marginal Integrity, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success of the ART restorations (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03657862, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.