Clinical trial NCT05772039: Treatment of Early Childhood Caries Using Silver Diammine Fluoride and Sodium Fluoride Tricalciumphosphate and the Effects on Oral Health Related Quality of Life
Official title: Minimally Invasive Treatment Approach for Early Childhood Caries Using Silver Diammine Fluoride and Sodium Fluoride With Functionalized Tricalcium Phosphate and Their Effects on Oral Health Related Quality of Life: A Pragmatic Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Early Childhood Caries
Dental Caries in Children
Dental Caries Extending Into Dentin
Dental Caries
Behavior, Child
Quality of Life
Keywords: SDF
NaF-fTCP
child behavior
pain experience
Wong-Baker Faces Pain rating scale
oral health-related quality of life
caries arrest
caries prevention
silver diammine fluoride
minimal intervention dentistry
Functionalized tricalcium phosphate
Sodium fluoride
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
Collaborators: name: 3M ESPE
name: SDI Limited
First posted: 2023-03-16
Enrollment: 72
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic randomized controlled trial
Primary purpose: TREATMENT

Brief summary: There is still a need for the assessment of different minimal intervention strategies and treatments focusing on the prevention and arrest of carious lesions of primary molars The evidence-based clinical practice guideline on non-restorative treatments for cavitated carious lesions advocate the use of silver diammine fluoride biannually for high caries risk patients

Detailed description: Although SDF has been proven to be highly effective in carious lesion arrest and prevention, the staining effect, metallic taste due to silver content and the minimal mucosal irritation have been noted as primary cause of disinterest among clinicians in the use of this material.

The use of NaF-fTCP as a caries preventive material has not been studied widely. The importance of oral hygiene education and diet modification to achieve an effective caries control has been widely discussed. The off-label use of NaF-fTCP as a caries arresting agent has not been studied on primary dentition. There is a dearth of evidence regarding the effectiveness of NaF-fTCP towards caries arrest and prevention in pragmatic settings.

A comparison between the SDF and NaF-fTCP application on the cavitated carious primary molars and their effect on the oral health-related quality of life of the children has not been published in the literature.

Eligibility criteria: Inclusion criteria:

Children will be invited to participate in the trial if they fulfil the entire selection criteria as described below:

* 4 to 6 years-of-age
* Identification of one or more carious primary molars without involvement of the pulp confirmed by bitewing radiographs
* Up to three teeth per each participant will be selected for intervention
* Has normal salivary flow rate
* Does not consume medications regularly for any medical condition
* Has not or will not receive any fluoride therapy or relevant dental therapy from other dental sources within the last six months

Exclusion criteria:

Children will be excluded from the trial if they fulfil any of the following criteria:

* Presence of any pain, ulceration, fistula/sinus or an abscess
* Premature hypermobility of carious teeth which can be potentially included in the study
* History of allergy to any product containing silver compounds
* Siblings of the participants will not be allowed to participate to ensure any chance of ECOHIS duplication.

Primary outcomes:
measure: Caries prevalence
timeFrame: Baseline
measure: Frequency distribution of caries risk
timeFrame: Baseline
measure: Mean score of oral health impact
timeFrame: Baseline
measure: Patient behaviour towards dental treatment
timeFrame: Baseline
measure: Mean score of pain experience
timeFrame: Baseline
measure: Mean value of caries experience
timeFrame: Baseline
measure: Extent of selected cavitated carious lesion using ICDAS
timeFrame: Baseline
measure: Extent of selected cavitated carious lesion using FOTI
timeFrame: Baseline
measure: Changes in the mean score of oral health impact
timeFrame: 6 months
measure: Changes in the mean score of patient behaviour towards dental treatment
timeFrame: 6 months
measure: Changes in the mean score of pain experience
timeFrame: 6 months
measure: Changes in the mean value of caries experience
timeFrame: 6 months
measure: Extent of selected cavitated carious lesion using ICDAS
timeFrame: 6 months
measure: Extent of selected cavitated carious lesion using FOTI
timeFrame: 6 months
measure: Changes in the mean score of oral health impact
timeFrame: 12 months
measure: Changes in the mean score of patient behaviour towards dental treatment
timeFrame: 12 months
measure: Changes in the mean score of pain experience
timeFrame: 12 months
measure: Changes in the mean value of caries experience
timeFrame: 12 months
measure: Extent of selected cavitated carious lesion using ICDAS
timeFrame: 12 months
measure: Extent of selected cavitated carious lesion using FOTI
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants reporting adverse events
timeFrame: Baseline
measure: Percentage of dropouts
timeFrame: 6 months
measure: Number of participants reporting adverse events
timeFrame: 6 months
measure: Percentage of dropouts
timeFrame: 12 months
measure: Number of participants reporting adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Crescent Montessori School
state: Punjab
Study officials:
affiliation: Universiti Sains Malaysia
name: Anas Imran Arshad, MSc., BDS
role: PRINCIPAL_INVESTIGATOR
References: