Background: Patients with cleft lip and/or palate (CL&/P) experience a higher caries prevalence. This study aimed to determine if patients with CL&/P, undergoing and not undergoing orthodontic treatment, have a different salivary biochemical profile and different salivary levels of Mutans Streptococci (MS) and Lactobacilli (LB) compared to patients undergoing and not undergoing orthodontic treatment without CL&/P. Methods: One hundred and ten subjects aged between 12 and 17 years were recruited into one of four different groups comprising two control groups and two treatment groups. The control groups comprised of subjects with and without CL&/P who were not undergoing orthodontic treatment. The treatment groups comprised of subjects with and without CL&/P undergoing orthodontic treatment. Regular reinforcement of oral hygiene instructions, dietary counselling and debridement, when necessary, were offered to subjects in the treatment groups following their orthodontic adjustment appointments. The salivary secretion time, pH of resting and stimulated saliva, salivary flow rate, buffering capacity, quantity of salivary MS and LB were measured. Results: Subjects with CL&/P undergoing orthodontic treatment at the Children's Oral Health Service tended to present with microbiological and salivary profiles that were less favourable for caries development. There was a significant difference in the percentage of subjects with Ն10 5 colony forming units (CFU)/mL of MS between the cleft treatment and non-cleft treatment groups. Subjects in the noncleft treatment group had the highest percentage of subjects (86.7 per cent) with Ն10 5 CFU/mL of MS whereas subjects in the cleft treatment group had the lowest percentage of subjects (60 per cent) with ≥10
S C I E N T I F I C A RT I C L Ehigher percentages of subjects with Ն10 5 CFU/mL of LB in the non-cleft treatment (76.7 per cent) and cleft treatment (73.3 per cent) groups compared to the non-cleft control (46.7 per cent) and cleft control (40.0 per cent) groups. Conclusions: Regular oral hygiene reinforcement and dental health education appears to have a positive effect in reducing the percentage of subjects with Ն105 CFU/mL of MS.Key words: Bacteria, saliva, cleft lip and palate, orthodontic treatment.Abbreviations and acronyms: ANOVA = analysis of variance; CFUs = colony forming units; CL&/P = cleft lip and/or palate; COHS = Children's Oral Health Service; DMFT = decayed, missing and filled permanent teeth; LB = Lactobacilli; MS = Mutans streptococci.