A clinical trial to evaluate the influence of Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) – Cranberry toothpastes in changing the bacterial composition of dental plaque deposits on teeth of orthodontic patients.

Not Applicable

Completed

• Conditions: Dental caries; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12618000095268
• Lead Sponsor: Prof. Laurence Walsh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-22
• Study Completion: 2018-11-20
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

(1)Undergoing fixed orthodontic treatment in both arches, with treatment having been underway for at least 1 month, (2) A minimum of 10 years of age and at least 4 fully erupted permanent maxillary anterior teeth. (3) Good general physical health as determined by a review of the medical history, (4) Available to attend a review appointment in 4 weeks, and (5) Not currently using antibiotics or any antibacterial/anti-plaque mouth rinses.

Exclusion Criteria

(1) Any medical condition or disability preventing normal manual tooth brushing, (2) Allergy to milk casein proteins or intolerance to any of the components of the CPP-ACP toothpastes, (3) Unwillingness to use a fluoridated dentifrice, (4) Untreated periodontal disease, (5) Clinical evidence of active caries.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The study assessed whether the test toothpastes could effect a beneficial change in the bacterial load numbers of 14 key bacterial species (8 cariogenic and 6 health-associated bacterial species) in the dental plaque of trial participants over the 5-6 week trial period.<br><br>Molecular microbiological analysis of dental plaque samples will be done using real-time quantitative polymerase chain reaction (qPCR) by 16S rRNA sequencing of the relevant plaque bacteria. <br><br>It is hypothesized that using the test toothpastes will result in reduced bacterial loads of 'harmful' cariogenic bacteria and increased bacterial loads of 'healthy' commensal bacteria. [5-6 weeks after baseline appointment]

Secondary Outcome Measures

Name	Time	Method
one[Nil]