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Trial registered on ANZCTR

Registration number

ACTRN12617000148370

Ethics application status

Approved

Date submitted

24/01/2017

Date registered

27/01/2017

Date last updated

27/01/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effect of a chewing gum on growth of dental plaque and gum inflammation in the absence of oral hygiene: A Pilot Study..

Scientific title

Effect of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) containing Sugar-free Chewing Gum on Experimental Gingivitis in healthy adults: A pilot comparative study

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1190-9076

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Gingivitis

Supragingival dental plaque formation and microbial composition of supragingival plaque.

Condition category

Condition code

Oral and Gastrointestinal

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 for 20 minutes, six times a day for 14 days each or not chew gum at all for 14 days. Each participant will complete each treatment and the order of treatments will be random. One gum will contain 56.4 mg of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) per one slab or two pellets of gum, The other gum will contain the same ingredients except it won't contain any CPP-ACP. During each 14-day treatment period, participants will abstain from all oral hygiene procedures (tooth brushing, use of interdental sticks, flossing, mouthwashes and any other oral hygiene aids) .There will be a 14-day rest period between each treatment period when they will resume oral hygiene procedures. 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 supragingival plaque removed from each posterior tooth, which will be pooled and 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 each treatment period.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The control treatment for the two gums will be the no gum chewing treatment and the control treatment for the gum containing CPP-ACP will be the same sugar-free gum but not containing CPP-ACP. Each participant will cross-over to each of the three treatments so will act as their own controls.

Control group

Placebo

Outcomes

Primary outcome [1]

Growth of supragingival plaque measured using the Turesky modification of the Quigley-Hein Index (plaque stained with a proprietary disclosing dye)..

Timepoint [1]

End of each 14-day treatment period.

Secondary outcome [1]

Development of gingivitis measured using the Modified Gingival Index.

Timepoint [1]

End of each 14-day treatment period.

Secondary outcome [2]

Change in microbial composition of supragingival plaque on posterior teeth.

Timepoint [2]

End of each 14-day treatment period.

Eligibility

Key inclusion criteria

1. Good general health.
2. Minimum of 20 natural teeth.
3. A gum-stimulated whole salivary flow rate 1.0 ml/minute and an unstimulated whole salivary flow rate of 0.2 ml/minute.
4. Available for each treatment period.

Minimum age

18 Years

Maximum age

55 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. Unrestored dentinal caries
6. Treatment with antibiotics or anti-inflammatory medication in the month prior to starting the study.
7. History of conditions requiring antibiotic coverage prior to invasive dental procedures.
8. Pregnancy/lactation.

Study design

Purpose of the study

Treatment

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

Sample size calculation was based on the paired t-test with alpha = 0.05, power = 0.8 and an estimated attrition rate of 10%. 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) were measured using a two-tailed test for repeated measures. The incidence of adverse events were also 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

20/11/2014

Date of last participant enrolment

Anticipated

Actual

10/03/2015

Date of last data collection

Anticipated

Actual

14/07/2015

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Royal Dental Hospital of Melbourne - Carlton

Recruitment postcode(s) [1]

3052 - Melbourne University

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Oral Health CRC

Address [1]

720 Swanston Street Carlton VIC 3052

Country [1]

Australia

Primary sponsor type

University

Name

University of Melbourne

Address

The University of Melbourne Parkville VIC 3010

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne Human Ethics Committee

Ethics committee address [1]

Level 5 MUPL Building, 161 Barry Street, University Square, Carlton, Victoria 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/06/2014

Approval date [1]

20/02/2015

Ethics approval number [1]

1441865

Summary

Brief summary

There is evidence that casein, a major protein in milk, combined with calcium and phosphate, called CPP-ACP may inhibit growth of dental plaque, alter the bacterial composition of plaque and inhibit development of gum inflammation. A large clinical study has been proposed, which will measure the effects of chewing gum containing CPP-ACP on dental plaque growth, plaque bacterial composition and gum inflammation. In order to determine whether this study is feasible, a smaller scale study (pilot study) is required to be conducted. 

The aims of this pilot study are to compare re-growth of dental plaque, changes in bacterial composition of plaque, and development of gum inflammation after: 1) chewing with sugar-free gum containing added CPP-ACP; 2) chewing with sugar-free gum without added CPP-ACP; 3) no gum chewing at all, each for 14 days each in the absence of all oral hygiene practices.

Eighteen adult participants will be recruited from staff and students of the Melbourne Dental Schools and their friends and family. Potential participants will first be screened by filling out a health questionnaire, having a dental examination by a qualified dentist on the research team, and providing two saliva samples; one at rest and one while chewing sugar-free gum, for two minutes each to ensure they produce normal amounts of saliva. These procedures will ensure participants will have no medical or dental conditions that might put them at risk by participating in this study. 

The order of the three treatments will be random for each participant and unknown to researchers analysing the results. If they are chewing one of the gums, they will chew two pellets of their allocated six times a day for 20 minutes each time and abstain from all oral hygiene practices and not chew any other gum for the 14 days. If they are not chewing gum they will just abstain from all oral hygiene practices and not chew any other gum for the  14 days. The identity of the gums will be unknown to the participants. 

At the start and end of each treatment period, participants will have a dental examination by the dentist on the research team to measure plaque (by staining their teeth with a plaque disclosing dye) and measure the amount of gum inflammation by visual inspection. They will also have plaque above the gums collected from all their posterior teeth, which will be pooled together and analysed later for bacterial composition. They will then have all their teeth cleaned by the dentist, At the end of the study they will also have a professional fluoride treatment. 

Participants will be instructed to contact the research team if they experience any problems during the study so that a qualified dentist on the team can assess and deal with the problem accordingly. Participants will be paid for their time and commitment to the study and will be free to exit the study at any time.

Trial website

Trial related presentations / publications

Public notes

The human ethics approval date is preceded by recruitment of the first participant as it was deemed necessary to recruit friends and family of staff and students of the Melbourne Dental School as well as just the staff and students of the school as originally planned and approved by the ethics committee. This change to the population from which participants could be recruited from was deemed necessary to ensure 20 participants who fulfilled eligibility criteria would be recruited. Hence an amendment to the original ethics application was submitted and approved after recruitment of participants had started.

Contacts

Principal investigator

Name

Prof Eric C. Reynolds

Address

Melbourne Dental School, University of Melbourne
720 Swanston St. Carlton, Victoria 3052

Country

Australia

Phone

+61 03 9341 1547

Fax

+61 03 9341 1596

e.reynolds@unimelb.edu.au

Contact person for public queries

Name

E.C. Reynolds

Address

Melbourne Dental School, University of Melbourne
720 Swanston St. Carlton, Victoria 3052

Country

Australia

Phone

+61 03 9341 1547

Fax

+61 03 9341 1596

e.reynolds@unimelb.edu.au

Contact person for scientific queries

Name

E.C. Reynolds

Address

Melbourne Dental School, University of Melbourne
720 Swanston St. Carlton, Victoria 3052

Country

Australia

Phone

+61 03 9341 1547

Fax

+61 03 9341 1596

e.reynolds@unimelb.edu.au

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

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No additional documents have been identified.

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