The Use of DryShield and Rubber Dam Isolation Systems Among Pediatric Patients With Different Airway Patency: A Randomized Clinical Trial

This study will aim to evaluate the effect of DryShield isolation system and rubber dam isolation on arterial oxygen saturation, heart rate, blood pressure, behavior, subjective pain and discomfort, and time required among 6-12-years-old healthy children with different airway patency based on Modified Mallampati classification scores.

This split-mouth randomized clinical trial will be conducted in the Pediatric Dentistry Department at King Abdulaziz University Dental Hospital Faculty of Dentistry (KAUDH) after obtaining ethical approval from the Research Ethics Committee at King Abdulaziz University.

Healthy, cooperative 6-12-year-old children who need fissure sealants in at least two contralateral fully erupted permanent first molars will be included. Children with partially erupted, previously restored, or carious first molars, children with uncooperative behavior during their previous dental treatment, children with fixed orthodontic appliances, and children with nasal obstruction will be excluded.

Children attending the pediatric dentistry clinics during the study period will be screened for eligibility. The parents or guardians of eligible children will be approached and given information about the study, including the risks, benefits, and drawbacks. If they agree to participate, an Arabic consent and assent form will be signed, and a treatment appointment will be scheduled. The airway patency assessment will be performed during the screening visit by two trained and calibrated dentists using Modified Mallampati classification scores. The participants will be asked to sit upright with their chin parallel to the floor, open their mouths to the maximum, and protrude their tongue without phonation to determine their Modified Mallampati classification score, ranging from one to four. Class I indicates that the soft palate, fauces, uvula, and tonsillar pillars are clearly visible. Class II means the soft palate, fauces, and the uvula are visible, while Class III is when only the soft palate and base of the uvula are visible. Finally, Class IV is when the soft palate is not visible. (13) Participants will be categorized based on their Modified Mallampati classification scores into two groups: patent airway (Class I and II) and non-patent airway (Class III and IV).

If a participant has more than two contralateral and fully erupted permanent first molars, only one pair of molars will be randomly selected to be included in the study.