Alhareky 2014.

Study characteristics
Methods	Design: split‐mouth RCT Recruitment period: not reported Administration setting: clinic in the Department of Pediatric Dentistry at Tufts University School of Dental Medicine Country: USA Funding source: in part by US Department of Health and Human Services Health Resources and Services Administration grant D84HP19955
Participants	Number of participants randomised: 42 patients Age: 7 to 16 years old, mean age 12.3 years old Sex: 19 males, 23 females Inclusion criteria: healthy children with no compromising medical or physical condition age from 7 to 16 years old with at least 1 caries‐free permanent molar in each quadrant, with normal anatomy, that qualified for the application of pit and fissure sealants cooperative children Exclusion criteria: history of chronic disease (e.g. epilepsy, ectodermal dysplasia, cardiac anomalies) unable to return for follow‐ups requiring less than 4 pit and fissure sealants on permanent molars children with partially erupted molars Number of participants evaluated: 42 patients Withdrawals/loss to follow‐up: none
Interventions	Total number of groups: 2 Intervention: rubber dam: "First, gingival soft tissue surrounding the tooth was dried. Topical anaesthesia was achieved using 20 per cent benzocaine gel, which was applied for one minute, according to the manufacturer’s instructions. A wingless clamp appropriate for use on molars was selected and then used in conjunction with a latex‐free RD sheet. No bite block was used with the RD" Control: Isolite system: "First, the isthmus (narrow part in the middle of the IS plastic mouthpiece) was placed at the corner of mouth, and the patient was instructed to open widely. The IS mouthpiece was then inserted while folding the cheek shield forward toward the tongue retractor and sliding the isthmus into the cheek. The patient was asked to bite on the bite block part of the IS. Finally, the cheek shield was tucked into the buccal vestibule, and the tongue retractor was tucked into the tongue vestibule. The high‐speed evacuation system was connected to the IS system, and a second high‐speed suction was used to evacuate the mouth during the sealant placement application" Restorative treatments: pit and fissure sealants on permanent molars
Outcomes	Outcomes: treatment time patient acceptance (evaluated using a questionnaire) Time points: immediately after restorative procedure
Notes	Adverse events: not reported This study was classified into 'studies awaiting classification' in the previous version of this review. It is now included after getting details of the method of randomisation used, preformation of allocation concealment, and funding sources from study authors
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "The randomisation schedule was generated using R 2.11.1 software (R Foundation for Statistical Computing, Murray Hill, NJ, USA)" Comment: method stated and appropriate
Allocation concealment (selection bias)	Unclear risk	Not reported Comment: insufficient information reported to make a judgement
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "The operators and patients were not blinded" Comment: high risk of bias
Blinding of outcome assessment (detection bias) All outcomes	High risk	Patients themselves were assessors by filling in the questionnaire Comment: the examiners were not blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	None lost to follow‐up Comment: low risk of bias
Selective reporting (reporting bias)	Low risk	Comment: the stated objectives and methods of the study appeared to match the listed outcomes, low risk of bias
Other bias	Low risk	No contamination and carry‐across effect was detected Comment: low risk of bias