Background: Children with autism spectrum disorder (ASD) and young pediatric patients often face challenges performing conventional mouth rinsing due to swallowing difficulties, sensory aversion, or poor coordination. Such barriers hinder fluoride exposure, increasing susceptibility to dental caries, plaque accumulation, and halitosis. Colgate Phos-Flur, a 0.044% sodium fluoride (acidulated phosphate) mouthwash, provides effective fluoride ion delivery that promotes remineralization and inhibits demineralization. When applied topically with a cotton applicator (ear bud) before bedtime, it offers controlled, targeted, and safe fluoride deposition on tooth surfaces.

Aim: To assess the preventive and therapeutic effects of nightly topical application of Colgate Phos-Flur mouthwash using an ear bud on caries progression, Halitosis, plaque accumulation, and symptom control in pediatric autistic children over a two-year period.

Methods: A two-year longitudinal randomized study will be conducted on 6–12-year-old children (n=60) divided into three groups:

Group I (Control): Standard toothbrushing with fluoride toothpaste.

Group II (Mouthrinse Group): Conventional rinse with Colgate Phos-Flur for 1 minute before bedtime.

Group III (Topical Application Group): Colgate Phos-Flur applied directly onto all tooth surfaces using a sterile ear bud, ensuring thin even coverage, once nightly before sleep.

Caregivers will be trained in the method, emphasizing “no post-application rinsing or drinking.”

Results: Topical Phos-Flur application with an ear bud is expected to provide equivalent caries-preventive efficacy compared with conventional rinsing, while being safer and better tolerated by autistic and younger children. A significant reduction in plaque scores, halitosis, and lesion progression is anticipated.

Clinical parameters (Plaque Index, ICDAS lesion scoring, pain/sensitivity VAS, and halitosis by halimeter) will be evaluated at baseline, 6, 12, 18, and 24 months.