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Trial registered on ANZCTR


Registration number
ACTRN12614001322628
Ethics application status
Not yet submitted
Date submitted
12/11/2014
Date registered
17/12/2014
Date last updated
17/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of commercial mouthwashes versus water and savacol on level of gingival inflammation and plaque accumulation in healthy adults: A parallel randomized placebo controlled single-blind clinical study.
Scientific title
Effect of commercial mouthwashes versus water and savacol on level of gingival inflammation and plaque accumulation in healthy adults: A parallel randomized placebo controlled single-blind clinical study.
Secondary ID [1] 285652 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gingival (gum) inflammation 293498 0
Condition category
Condition code
Oral and Gastrointestinal 293777 293777 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
Commercial mouthwashes

1)Listerine with alcohol

a)Active ingredients - Eucalyptol = 0.092%, Menthol = 0.042%, Methyl salicylate = 0.060%, Thymol = 0.064%.

b) Dose = 20ml mouth rinsing for 30 seconds, 2 x daily (morning and night after meals).

c) Duration = 3 weeks

d) Mode of administration = mouth rinsing for 30 seconds

2) Listerine without alcohol

a) Active ingredients - Sodium fluoride = 0.02%

b) Dose = 10ml mouth rinsing for 60 seconds 2 x daily (morning and night after meals).

c)Duration = 3 weeks

d) Mode of administration = mouth rinsing for 60 seconds

3)Savacol without alcohol

a)Active ingredients - 2mg/ml chlorhexidine gluconate

b) Dose = 10 ml mouth rinsing for 60 seconds 2 x daily (morning and night)

c)Duration = 3 weeks

d) Mode of administration = mouth rinsing for 60 seconds

4)Aloe Vera mouthwash

a) Active ingredients - Aloe vera, Peppermint, Tea tree, Icelandic moss, Arnica, Indian Pennywart, Grapefruit seed extract (concentrations of each ingredient have not been specified by the manufacturer).

b) Dose = 10ml mouth rinsing for 60 seconds 2 x daily (morning and night).

c)Duration = 3 weeks

d) Mode of administration = mouth rinsing for 60 seconds

2) Adherence to the intervention will be monitored by weighing the bottles at each visit.
Intervention code [1] 290595 0
Prevention
Comparator / control treatment
1)Savacol with alcohol (positive control)

Active ingredient - 2mg/ml chlorhexidine gluconate

a) Dose = 15 ml mouth rinsing for 60 seconds 2 x daily (morning and night)

b) Duration = 3 weeks

c)Mode of administration = mouth rinsing for 60 seconds

2)Water (negative control)

a) Dose = 15ml of mouth rinsing for 60 seconds 2 x daily (morning and night)

b) Duration = 3 weeks

c) Dose of administration = mouth rinsing for 60 seconds

3) Adherence to the mouth rinsing agents will be monitored by weighing the bottles at each visit.
Control group
Placebo

Outcomes
Primary outcome [1] 293578 0
plaque (bacterial) accumulation as assessed using:

1) In the field of dentistry the plaque index by Silness and Loe 1964 is assessed by visually inspecting the teeth for the amount and extent of plaque accumulation and is graded from 0-3.

0= no plaque
1= minimum plaque accumulation
2= moderate plaque accumulation
3= abundant plaque accumulation

The professional description is

0 - No plaque

1 - A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which cannot be seen with the naked eye. But only by using disclosing solution or by using a probe.

2 - Moderate accumulation of deposits within the gingival pocket, on the gingival margin and or adjacent tooth surface, which can be seen with the naked eye.

3 - Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Timepoint [1] 293578 0
three weeks
Primary outcome [2] 293866 0
plaque (bacterial) accumulation as assessed using:

2) In the field of dentistry the plaque accumulation by Rustogi et al. Modified Navy Plaque Index (RMNPI)s assessed by visually inspecting the teeth for the presence of plaque (1) and absence of plaque (0).

The professional description is :

The RMNPI plaque is evaluated as either present or absent (1 or 0) on each of the nine areas of the buccal and lingual tooth
Timepoint [2] 293866 0
three weeks
Primary outcome [3] 293867 0
plaque (bacterial) accumulation as assessed using:

3) In the field of dentistry the plaque index - modified Lobene stain index 1968 is measured by applying a pink dye on the tooth and will be visually inspected by the extent the colour is retained on the tooth.

0= absent
1= present

The professional description is

The tooth will be divided into six areas

Buccal surface: Anterior tooth – labial (I), approximal (A), gingival (G)

Posterior teeth - buccal (B), approximal (A), gingival (G)

Palatal surface: Anterior tooth - palatal (P), approximal (A), gingival (G)

Posterior teeth – palatal (P), approxiaml (A), gingival (G)

When at least one area of the considered teeth in a patient was found to be pigmented that area will be considered to be positive at the patient level
Timepoint [3] 293867 0
three weeks
Secondary outcome [1] 311395 0
gingival (gum) inflammation as assessed using:

1)In the field of dentistry the gingival index by Loe and Silness 1963 is assessed by visually inspecting the change in colour of the gum around the tooth.

0= pink
1= dark pink
2= red
3= dark red

The professional description is

0 – No inflammation

1 – Mild inflammation, slight change in colour, slight edema, no bleeding on probing.

2 – Moderate inflammation, moderate glazing, redness, bleeding on probing.

3 – Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.
Timepoint [1] 311395 0
three weeks
Secondary outcome [2] 312033 0
gingival (gum) inflammation as assessed using:

2) In the field of dentistry the Papillary bleeding index by Muhlemann 1977 is measured routinely in which a dedicated periodontal probe is used by gently inserting the probe beside the tooth to see how easily bleeding of the gums occurs.

0= no bleeding
1= mild bleeding at one spot
2= mild bleeding at more than one spot
3= severe bleeding at one spot
4= severe bleeding at more than one spot

The professional description is

0 - No bleeding

1 - Only one bleeding point appearing

2 - Several isolated bleeding point

3 - Interdental triangle filled with blood soon after probing

4 - Profuse bleeding when probing, blood spreads towards the marginal gingiva
Timepoint [2] 312033 0
three weeks

Eligibility
Key inclusion criteria
1. The absence of untreated caries, secondary caries or faulty restorations.
2. No removable prosthesis or orthodontic appliances (re movable or/and fixed)
3. No oral lesions, no periodontal problems (healthy gingival and periodontium)
4. Generally healthy, no known allergies against ingredients of the mouthwashes
5. Non smokers
6. Last antibiotic treatment atleast 3 months prior to start of the study
7. Participants should not be taking any non steroidal anti-inflammatory drugs in the last 3 months
8. Not using a mouthwash in the last 2 weeks
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Pregnancy, lactation
2. Any chronic disease
3. Cardiac disease
4. Diseases of the immune system
5. History of rheumatic fever
6. Splenectomy
7. Presence of signs and symptoms of an acute infection in the oral cavity
8. Any prescribed systemic or topical medication except oral contraceptives
9. Use of antibiotics in the last 3 months
10. History of alcohol or drug abuse
11. Participation in other clinical studies in the last 6 months

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)
Computer based program will allocate subjects into the six groups

Allocation concealment - The allocation of the participants into groups will be concealed in sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer based program will generate the sequence in which subjects will be randomised
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Total Number of participants
15-20 participants in each of the Groups A, B,C,D,E,F
90-120 participants overall
Sample size was calculated from Marchetti et al (2011) who investigated the difference in plaque scores between an alcohol and non-alcohol based mouthwash between two groups. Using the means of 71.6 (+/- 13.4) and 58.6 (+/- 12.5) for the non-alcohol and alcohol based mouthwashes, respectively, a two-sided test, an alpha of 0.05, and power of 0.80, the sample size was determined as 16 participants per group.



All data will be analysed using IBM Statistical Package for Social Sciences (SPSS) V21. Data will initially be analysed descriptively using graphs and tables. Crosstabs will be used to determine group percentages across the ordinal and nominal data measuring the levels of gingival inflammation (for example, periodontal and gingival indexes). Means and standard errors will be used for the parametric data obtained from the VAS measures in the self-report questionnaire.
Statistical significance will be calculated using p < 0.05. Differences between the groups will be determined using Kruskal Wallis test on the ordinal and nominal data of the gingival inflammation indices and ANOVA with multiple comparison (Bonferroni corrected) for the VAS measures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3139 0
Sydney Dental Hospital - Surry Hills
Recruitment postcode(s) [1] 8895 0
2010 - Surry Hills

Funding & Sponsors
Funding source category [1] 290238 0
University
Name [1] 290238 0
University of Sydney
Country [1] 290238 0
Australia
Primary sponsor type
Hospital
Name
Sydney Dental Hospital
Address
Sydney Dental Hospital
2 Chalmers Street
Surry Hills
NSW -2010
Country
Australia
Secondary sponsor category [1] 288945 0
None
Name [1] 288945 0
Address [1] 288945 0
Country [1] 288945 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291941 0
Ethics for human research (RPAH zone)
Ethics committee address [1] 291941 0
Research and Ethics Office
Locked Bag 7103
Liverpool BC NSW 1871
Ethics committee country [1] 291941 0
Australia
Date submitted for ethics approval [1] 291941 0
20/11/2014
Approval date [1] 291941 0
Ethics approval number [1] 291941 0
X14-0278

Summary
Brief summary
Participants between the age of 18 – 35 yrs old that fulfill the inclusion criteria will be chosen to take part in the study. All participants will be randomly assigned to one of six groups 14 days prior to commencement of the study. All the participants will receive a dental clean and will be advised to stop the use of their regular mouthwash. When the experiment begins (day 0) participants will be advised to follow the experimental oral hygiene protocol. And they will be advised to use one of five mouthwashes (or water which is a negative control). Five different gum measurements will be measured and the soft tissue health will be noted at all four visits from the start of the experimental period. At the last visit participants will be requested to fill a questionnaire form as well. In addition they will also receive a dental clean to remove bacterial accumulation on their teeth and extrinsic tooth staining.

There is significant evidence in the current literature that commercial alcohol containing mouthwashes such as Savacol (Registered Trademark) and Listerine (Registered Trademark) reduce bacterial accumulation and gum inflammation. However despite some progress, there is a huge gap in clinical evidence demonstrating the efficacy of commercially available non-alcohol containing mouthwashes such as Savacol (Registered Trademark), Listerine Zero (Registered Trademark) and a herbal mouthwash – Dr Organics Aloe Vera (Registered Trademark) mouthwash, in the prevention of bacterial accumulation and gum inflammation. This study is expected to give us more evidence about the benefits that these non-alcohol containing mouthwashes can provide to our patients.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes
Nil
Attachments [1] 237 237 0 0
/AnzctrAttachments/367420-Study Design.pdf
Attachments [2] 246 246 0 0
/AnzctrAttachments/367420-Revised Main Variables.doc

Contacts
Principal investigator
Name 52738 0
A/Prof Axel Spahr
Address 52738 0
Sydney Dental Hospital
2 Chalmers Street
Surry Hills
NSW - 2010
Country 52738 0
Australia
Phone 52738 0
+ 61 2 9293 3274
Fax 52738 0
+ 61 2 9293 3335
Email 52738 0
[email protected]
Contact person for public queries
Name 52739 0
Dr Olivia Nova
Address 52739 0
Sydney Dental Hospital
2 Chalmers Street
Surry Hills
NSW - 2010
Country 52739 0
Australia
Phone 52739 0
+61 2 9293 3274
Fax 52739 0
+61 2 9293 3335
Email 52739 0
[email protected]
Contact person for scientific queries
Name 52740 0
Dr Olivia Nova
Address 52740 0
Sydney Dental Hospital
2 Chalmers Street
Surry Hills
NSW - 2010
Country 52740 0
Australia
Phone 52740 0
+61 2 9293 3274
Fax 52740 0
+61 2 9293 3335
Email 52740 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.