Evaluation of the Prebiotic Effect of New Dentifrice Formulations In Healthy Adults

Not Applicable

• Conditions: Oral Health; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12623000893606
• Lead Sponsor: The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-21
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Inclusion Criteria:
To be eligible to participate in this study, an individual must meet all of the following criteria:
1.Ability to understand, and willingness and ability to read and sign, the informed consent form.
2.Age range: 18 to 75 years old.
3.Good general health.
4.Minimum of 20 natural teeth.
5.A gum-stimulated whole salivary flow rate greater than or equal to 1.0 ml/minute and unstimulated whole salivary flow rate greater than or equal to 0.2 ml/minute.
6.A baseline mean whole-mouth modified gingival index greater than or equal to 1.5.
7.A baseline mean whole-mouth plaque index greater than or equal to 1.5.
8.A baseline mean whole-mouth sulcus bleeding index greater than or equal to 1.0.
9.Willingness to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria

Exclusion Criteria:
Individuals who manifest ANY of the following exclusion criteria at the time of randomization will NOT be eligible for the study:
1.Allergy to milk protein, tin or other ingredients in toothpaste products.
2.Orthodontic appliances or removable prostheses.
3.Veneers, or more than one incisor with a prosthetic crown.
4.Gross oral pathology (including periodontal disease {Community Periodontal Index of Treatment Needs [CPITN] greater than or equal to 3} and tumours of the soft or hard oral tissues).
5.Chronic disease with concomitant oral manifestations (e.g., diabetes [irrespective of level of control], human immunodeficiency virus infection or acquired immunodeficiency syndrome, use of medications associated with gingival hyperplasia).
6.Unrestored dentinal caries.
7.Treatment with antibiotics or anti-inflammatory medication in the month prior to starting the study.
8.Concomitant pharmacotherapy with drugs that may interact with test drug.
9.History of conditions requiring antibiotic coverage prior to invasive dental procedures.
10.Pregnancy/lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in gingivitis.<br><br>Tools/tests to be used for assessment:<br>Clinical examination will be performed at the start and finish of the treatment period by a trained dentist.<br>Gingivitis will be measured using the Modified Gingival Index (MGI – Lobene et al., 1986). This index is a modification of the Löe and Silness (1963) Gingival Index and allows greater discrimination for mild and moderate gingivitis. In this study, gingival inflammation on a scale from 0 to 4 will be scored for gingival tissues associated with four sites (buccal, lingual, mesial and distal) of all teeth (excluding third molars).[ Baseline before intervention, and 21 days post-intervention commencement.]