A study to compare the decay arrest of two different fluoride products when applied to the teeth of children aged between 2 and 5 years in a rural setting near Port Moresby, Papua New Guinea.

Effectiveness of bi-annual application of 38% silver diamine fluoride solution compared to 5% sodium fluoride varnish on arrested carious lesions on primary teeth in children aged 2-5 years in a rural setting near Port Moresby, Papua New Guinea

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000452998

Enrollment

104

Registered

2020-04-08

Start date

2018-12-04

Completion date

2018-12-14

Last updated

2020-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The hypothesis is that bi-annual topical application of 38% silver diamine fluoride will be superior to bi-annual topical application of 5% sodium fluoride varnish in arresting dental decay in children 2-5 years of age. This is an interventional parallel arm, randomised study. The participants will be recruited from a rural Papua New Guinean village. Consent will be obtain from the children and their guardian. The children will be clinically examined, visual and tactile, at baseline, 6 and 12 months by a callibrated dental practitioner. Dental caries progression will be assessed and recorded. The primary outcome measure of the study is the number of active caries arrested at the end of the trial.

Interventions

One local dental practitioner who is also in the research team will apply the medicaments to the teeth with signs of dental decay. The two treatment arms include: Group 1: Bi-annual topical application of a thin film of 38% silver diamine fluoride solution and Group 2: Bi-annual topical application of a thin film of 5% sodium fluoride varnish Clinical examinations will be conducted at baseline, 6 and 12 months period. 38% SDF solution or 5% NaF varnish will be applied at baseline and re-appl

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

2 Years to 5 Years

Healthy volunteers

Inclusion criteria

Children aged 2 to 5 years old from a rural village in Papua New Guinea In good health Have at least one carious tooth. Have obtained informed consent and able to accept intervention

Exclusion criteria

Children younger than two years or older than five years Children who exhibit signs of tooth non-vitality such as pulp exposure, presence of an abscess or sinus, hypermobility, retained roots of teeth Children who are undergoing dental treatment or long-term medical treatment Children with special healthcare needs,

Outcome results