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. 2021 May 17;2021(5):CD009858. doi: 10.1002/14651858.CD009858.pub3

Ammann 2013.

Study characteristics
Methods Design: parallel‐group RCT
Recruitment period: not stated
Administration setting: private dental clinic
Country: Germany
Funding source: Dentsply DeTrey, Konstanz, Germany
Participants Number of participants randomised: 72 (rubber dam: 34; cotton rolls: 38)
Randomisation unit: participant
Age: 5.9 to 16.9 years, mean age 11.1 years
Sex: 23 boys, 49 girls
Inclusion criteria:
  • aged 6 to 16 years

  • given indication for fissure sealing


Exclusion criteria:
  • participation in other studies evaluating parameters of stress

  • not totally erupted teeth to seal

  • lack of compliance

  • no agreement from the guardians

  • presence of fixed orthodontic appliances

  • signs of opacity and brown discolouration of the tooth to be sealed

  • psychotropic medication or cardiovascular drugs

  • already sealed teeth

  • present disease (cold)

  • allergic reactions to used materials


Number of participants evaluated: 72 (rubber dam: 34; cotton rolls: 38)
Withdrawals/loss to follow‐up: no withdrawals
Interventions Number of groups: 2
Intervention: rubber dam: "A suitable rubber dam clamp (Ivoryò; Sigma Dental Systems, Handewitt, Germany) was selected and applied. Afterwards, the rubber dam was placed over the clamp. Several teeth were included in the rubber dam in cases involving premolars, whereas for molars only the treated tooth was isolated"
Control: cotton rolls: "The cotton rolls were positioned on the buccal and lingual region of the tooth to be sealed and were fixed by the operator's index finger and middle finger. Additionally, a saliva ejector was placed on the lingual side"
Restorative treatment: pit and fissure sealants on premolars/molars
Outcomes Outcomes:
  • treatment time


Time points: immediately after restorative procedure
Notes Adverse events: not stated
No details on sample size or power calculation were provided
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "72 subjects successfully took part in the study and were divided into two parallel groups by a dental assistant by drawing sealed lots (test n = 34; control n = 38)"
Comment: method stated and appropriate
Allocation concealment (selection bias) Unclear risk Not stated
Comment: insufficient information reported to make a judgement
Blinding of participants and personnel (performance bias)
All outcomes High risk Comment: the operators and the participants could not be blinded
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not stated
Comment: insufficient information reported to make a judgement
Incomplete outcome data (attrition bias)
All outcomes Low risk No withdrawals
Selective reporting (reporting bias) High risk Quote: "The time needed to finish the fissure sealing treatment was 12.4% (108 s [seconds]) less when using rubber dam (P < 0.05)"
Comment: insufficient information reported to use the data in the analysis
Other bias Low risk Comparable groups at baseline (age, gender, type of teeth treated)