Alhareky 2014.

Methods	Design: split‐mouth Recruitment period: not reported Administration setting: teaching clinic of dental school 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; 168 teeth (rubber dam: 84; Isolite system: 84) Randomisation unit: teeth Age: 7 to 16 years, mean age 12.3 years Sex: 19 boys, 23 girls Inclusion criteria: healthy children with no compromising medical or physical condition aged 7 to 16 years children with ≥ 1 caries‐free permanent molar in each quadrant, with normal anatomy that qualified for the application of pit and fissure sealants co‐operative children Exclusion criteria: history of chronic disease unable to return for follow‐ups requiring < 4 pit and fissure sealants on permanent molars children with partially erupted molars Restorative treatments received: pit and fissure sealing of permanent molar Number of participants evaluated: 42; 168 teeth (rubber dam: 84; Isolite system: 84) Withdrawals/loss to follow‐up: no loss to follow‐up
Interventions	Number of groups: 2 Intervention: RD: "First, gingival soft tissue surrounding the tooth was dried. Topical anesthesia was achieved using 20 percent 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: IS: "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"
Outcomes	Treatment time, patient acceptance (evaluated using a questionnaire)
Notes	Adverse events: not reported Sample size calculation: not reported Awaiting responses from authors on the details of the method of randomisation used, preformation of allocation concealment and funding sources

IS: Isolite system; RD: rubber dam.