OBJECTIVE: To assess oral health-related quality of life (OHRQoL) changes before 
and after the primary surgical treatment in infants with cleft lip and/or palate 
(CL/P).
DESIGN: Quasi-experimental study.
METHODS: A total of 106 infants with CL/P younger than 2 years undergoing 
primary surgical treatment in the Plastic Surgery Service of the Instituto 
Nacional de Salud del Niño in Peru. The parent/caregiver answered a 
questionnaire about OHRQoL named the Peruvian version of the Early Childhood 
Oral Health Impact Scale (P-ECOHIS) in the pretreatment (baseline) and follow-up 
post-treatment. The total score of P-ECOHIS and their 2 sections (child impact 
and family impact) in the baseline and each follow-up period post-treatment 
scores were assessed. As well as, the type of the CL/P on OHRQoL, standardized 
effect sizes (ES) based on mean total change scores (difference between baseline 
and 12th month) were analyzed.
RESULTS: Improvements in infant's OHRQoL after treatment were reflected in each 
follow-up period P-ECOHIS score compared to the baseline score. The total 
P-ECOHIS scores decreased significantly from 28.07 (baseline) to 7.7 (12th 
month; P < .0001), as did the individual domain scores (P < .0001). There were 
significant differences in the baseline and follow-up post-treatment scores of 
infants who reported improvement of the OHRQoL (P < .0001). The ES was large 
(3.79). The cleft lip had an improvement in the OHRQoL at 12th month 
post-treatment (P < .0001).
CONCLUSIONS: Primary surgical post-treatment resulted in significant improvement 
of the infant's OHRQoL with CL/P.