Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000149369
Ethics application status
Approved
Date submitted
24/01/2017
Date registered
27/01/2017
Date last updated
12/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of a chewing gum on growth of dental plaque and gum inflammation in the presence of oral hygiene: A Pilot Study.
Scientific title
Effect of a Sugar-free Chewing Gum containing Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) on Supragingival Plaque Composition in the Presence of Normal Oral Hygiene Procedures in Healthy Adults.
Secondary ID [1] 290782 0
Nil
Universal Trial Number (UTN)
U-1111-1191-0395
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gingivitis 301395 0
Supragingival dental plaque formation and microbial composition of supragingival plaque. 301396 0
Condition category
Condition code
Oral and Gastrointestinal 301140 301140 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to chew one slab of two different sugar-free gums containing two different levels of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) for 20 minutes, six times a day for 14 days each (two separate 14-day treatment periods), and not chew gum at all for 14 days ("no-gum" 14-day treatment period). Each participant will complete each treatment with two 14-day rest periods between treatment periods. The order of treatments will be random. One gum will contain 56.4 mg CPP-ACP per two pellets or one slab and the other will contain 18.8 mg CPP-ACP per two pellets or one slab of gum. During the week prior to commencement of the first treatment period, during each 14-day treatment period and during the two intervening 14-day rest periods, participants will be instructed to brush their teeth twice a day with a sodium fluoride toothpaste (1000 ppm fluoride) (toothpaste and brush supplied) but will be instructed not to use any other oral hygiene aids such as toothpicks, floss or mouthrinses and not to chew with any other gum. At the beginning and end of each treatment period, participants will have their gums examined to score the level of gingivitis and will also have supragingival plaque levels measured using a plaque-disclosing dye. They will then have all dental plaque removed from the cheek-facing surfaces of the crowns of their first and second upper molars, which will be later analysed for microbial composition. They will then have all supragingival plaque removed from all remaining teeth (professional scale and clean). At the end of the study they will also have a professional fluoride treatment . All dental examinations, plaque sampling, tooth cleaning and fluoride treatments will be conducted by a qualified dentist on the research team. Participants will return all used and unused gum wrappers at the end of the two treatment periods they chew one of the two gum products.
Intervention code [1] 296694 0
Treatment: Other
Comparator / control treatment
The control treatment for the two gums will be the "no gum" chewing treatment Each participant will cross-over to each of the three treatments so will act as their own controls.
Control group
Active

Outcomes
Primary outcome [1] 300543 0
Development of gingivitis measured using the Modified Gingival Index.
Timepoint [1] 300543 0
End of each 14-day treatment period.
Secondary outcome [1] 330281 0
Growth of supragingival plaque measured using the Turesky modification of the Quigley-Hein Index (plaque stained with a proprietary disclosing dye)..
Timepoint [1] 330281 0
End of each 14-day treatment period.
Secondary outcome [2] 330282 0
Change in microbial composition of supragingival plaque on maxillary molar teeth.
Timepoint [2] 330282 0
End of each 14-day treatment period.

Eligibility
Key inclusion criteria
1. Ability to understand, and willingness and ability to read and sign, the informed consent form.
2. Age range: 18 to 65 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. Willingness to comply with all study procedures and be available for the duration of the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Allergy to milk protein or other ingredients in the gum product.
2. Orthodontic appliances or removable prostheses.
3. Veneers, or more than one incisor with a prosthetic crown.
4. Gross oral pathology (including periodontal disease (CPITN score 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 substance.
9. History of conditions requiring antibiotic coverage prior to invasive dental procedures.
10. Pregnancy/lactation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
By a randomisation table created by computer software using block randomisation so that each sequence selected is equally likely.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The range of means and standard deviations used in the sample size calculations was based on the previous pilot study. In that study, the mean difference in abundance of S. sanguinis between the CPP-ACP gum and the control gum was 1.87% and the standard deviation of the difference was 4.73%. Sample size calculation was based on the paired t-test with alpha = 0.05, power = 0.8 and an estimated attrition rate of 10%. Assuming a standard deviation of 4.5% and a 10% percent attrition rate, a sample of at least 18 participants was deemed necessary to allow for a mean difference in abundance of S. sanguinis of 3.5% to be detected with a power of 80 percent. Differences in the outcome measures: Turesky modification of the Quigley-Hein Index for the plaque levels, the Modified Gingival Index for severity of gingivitis and changes in bacterial composition (such as for the species S.sanguinis) will be measured using a two-tailed test for repeated measures. Differences in the saliva bacterial community over time will be determined by measuring the changes in the relative abundances of bacterial species for each participant.
This will enable a comparison of the effect of CPP-ACP on the bacterial composition of the plaque. The four plaque samples from each individual will enable determination of intra-participant variation in bacterial composition of plaque. The incidence of adverse events will also be measured and differences measured between treatment groups were measured using Cochrane-Mantel-Haentzel test where necessary.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2016
Date of last participant enrolment
Anticipated
Actual
29/11/2016
Date of last data collection
Anticipated
Actual
16/12/2016
Sample size
Target
18
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7168 0
The Royal Dental Hospital of Melbourne - Carlton
Recruitment postcode(s) [1] 14927 0
3052 - Melbourne University
Recruitment postcode(s) [2] 14928 0
3053 - Carlton

Funding & Sponsors
Funding source category [1] 295201 0
Other Collaborative groups
Name [1] 295201 0
Oral Health CRC
Country [1] 295201 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
The University of Melbourne Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 294033 0
None
Name [1] 294033 0
Address [1] 294033 0
Country [1] 294033 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296553 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 296553 0
Ethics committee country [1] 296553 0
Australia
Date submitted for ethics approval [1] 296553 0
20/04/2016
Approval date [1] 296553 0
24/05/2016
Ethics approval number [1] 296553 0
1646513

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71266 0
Prof Eric C. Reynolds
Address 71266 0
Melbourne Dental School, University of Melbourne
720 Swanston St. Carlton, Victoria 3052
Country 71266 0
Australia
Phone 71266 0
+61 03 9341 1547
Fax 71266 0
+61 03 9341 1596
Email 71266 0
[email protected]
Contact person for public queries
Name 71267 0
Eric C. Reynolds
Address 71267 0
Melbourne Dental School, University of Melbourne
720 Swanston St. Carlton, Victoria 3052
Country 71267 0
Australia
Phone 71267 0
+61 03 9341 1547
Fax 71267 0
+61 03 9341 1596
Email 71267 0
[email protected]
Contact person for scientific queries
Name 71268 0
Eric C. Reynolds
Address 71268 0
Melbourne Dental School, University of Melbourne
720 Swanston St. Carlton, Victoria 3052
Country 71268 0
Australia
Phone 71268 0
+61 03 9341 1547
Fax 71268 0
+61 03 9341 1596
Email 71268 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.