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. 2022 Feb 11;2022(2):CD012981. doi: 10.1002/14651858.CD012981.pub2

Joshi 2019.

Study characteristics
Methods Design: hybrid RCT with split‐mouth design (for comparison of retention of different sealant types)
Number of participants: 111
Setting: paediatric dental department of a dental college
Country: India
Unit of randomisation: 2‐stage randomisation. At first, tooth pairs were randomised into study and control groups (sealant vs no sealant). Next, in study group alone, each tooth in a tooth pair was randomised to receive additional light curing or not
Unit of analysis: tooth
Follow‐up mean: 1 year
Dropout: 10 teeth (8 teeth in study group and 2 teeth in control group)
Participants Number randomised: 180 pairs of primary second molars
Number analysed: 175 pairs of primary molars
Age: mean 4.19 years (range 3–5 years)
Sex: 64 boys and 47 girls
Mean dmft score: 8.45 SD 6.4 in study group and 8.35 SD 5.4 in control
Inclusion criteria: fully erupted primary teeth with ≥ 1 pair of bilateral maxillary/mandibular caries‐free primary second molars, no history of preventive treatment in preceding 6 months, high risk of developing caries
Exclusion criteria: permanent molars, medically compromised, children with physical limitation
Baseline caries risk of participants: high caries risk
Interventions 2 treatment arms
  • Study group subdivided into 2:

    • high‐viscosity GIC (Ketac Universal, 3M oral care, St Paul, Minnesota, USA)

    • high‐viscosity GIC (Ketac Universal, 3M oral care, St Paul, Minnesota, USA) with additional light curing using blue lex LD 1.5 monitex, Taiwan for 60 seconds

  • Control group: without sealant


Co‐intervention: demonstration using videos and models for proper tooth brushing; all participants brushed twice daily with low‐fluoride toothpaste in all groups.
Outcomes Study primary outcome
  • Caries incidence


Study secondary outcomes
  • Sealant retention assessed as no loss, partial loss and complete loss

  • Marginal discolouration


Caries diagnostic criteria: visual using ICDAS
Notes Funding: none (additional information provided by the author)
Trial register: registered (CTRI/2017/10/010248)
Inter‐evaluator consistency: kappa values were 0.6 for dental caries and 0.7 for sealants
Sample size: not calculated
Personal communication: Sakshi 2019
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "lottery method, even numbers for the study group and odd numbers for the control group, another round of randomisation was also done by asking the child to pick up the chit with right or left written on it."
Allocation concealment (selection bias) Unclear risk Comment: additional information provided by the author as allocation concealment done. However, no information provided on how it was done.
Blinding of participants and personnel (performance bias)‐Participants High risk Comment: children would be aware that they were receiving sealant or no sealant or an additional light‐curing technique.
Blinding of participants and personnel (performance bias)‐ Operator High risk Comment: additional information provided by the author that operator was not blinded as single operator performed all the intervention.
Comment: blinding operator was not possible as 1 required light curing and the other did not.
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "Assessors were blinded."
Comment: blinding outcome assessor not possible to compare sealant with no sealant.
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "At the first follow up a total dropout of 8 teeth in study group and 2 teeth in control group was recorded. No further dropouts occurred."
Comment: drop‐out low and similar across groups. Reasons for drop‐out due to patient non‐attendance at clinical examination.
Selective reporting (reporting bias) Low risk Comment: all prespecified outcomes were reported.
Other bias Low risk No evidence of any other bias.