Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000567628
Ethics application status
Approved
Date submitted
31/03/2023
Date registered
25/05/2023
Date last updated
25/05/2023
Date data sharing statement initially provided
25/05/2023
Date results information initially provided
25/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative efficacy of two anti-plaque agents on dental plaque regrowth in toddlers
Scientific title
Comparative efficacy of topical povidone-iodine and chlorhexidine gel on dental plaque regrowth in toddlers: a randomized controlled trial
Secondary ID [1] 309368 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental plaque 329584 0
Condition category
Condition code
Oral and Gastrointestinal 326508 326508 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
The toddlers were randomly assigned to three groups. The first group received a placebo distilled water (negative control). The second group received topical chlorhexidine gel (0.2% w/v) (positive control). The third group received topical povidone iodine solution (10% w/v). The antiplaque agent was applied using a cotton-tipped swab. Plaque accumulation was measured at the baseline (t0), after three days (t1), and after 7 days (t2) using the Turesky modified Quigley-Hein plaque index (TMQHPI). Dental plaque was disclosed using the two-tone erythrosine-free plaque disclosing dye solution Mira-2-Ton® (Hager & Werken, Duisburg, Germany). The toddler’s legal guardians were instructed to avoid feeding their child for 30-60 minutes post-antiplaque agent application and oral hygiene practices were prohibited during the trial period.
The dose administered: 2 ml.
The duration of administration: single application.
The mode of administration: topically applied by dentist.
Intervention code [1] 325799 0
Prevention
Comparator / control treatment
The first group received a placebo distilled water (negative control). The second group received topical chlorhexidine gel (0.2% w/v) (positive control).
Control group
Active

Outcomes
Primary outcome [1] 334352 0
Dental plaque accumulation changed from the baseline
Turesky-modified Quigley-Hein plaque index was used to assess the outcome
Timepoint [1] 334352 0
After 3 days
Secondary outcome [1] 420347 0
Dental plaque accumulation changed from the baseline
Turesky-modified Quigley-Hein plaque index was used to assess the outcome
Timepoint [1] 420347 0
After 7 days

Eligibility
Key inclusion criteria
Children aged 24-36 months.
Healthy children.
Minimum age
24 Months
Maximum age
36 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children with special health care needs (SHCN).
Children receiving any antibiotic therapy over the past four weeks.
Children with thyroid disorders or iodine allergies.
Children with CHX allergies.

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)
Patients were randomized using randomization online software; http://www.randomization.com.
Allocation is not concealed
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/12/2022
Date of last participant enrolment
Anticipated
Actual
27/02/2023
Date of last data collection
Anticipated
Actual
6/03/2023
Sample size
Target
56
Accrual to date
Final
45
Recruitment outside Australia
Country [1] 25368 0
Syrian Arab Republic
State/province [1] 25368 0

Funding & Sponsors
Funding source category [1] 313565 0
University
Name [1] 313565 0
Damascus University
Country [1] 313565 0
Syrian Arab Republic
Primary sponsor type
Individual
Name
Mawia Karkoutly
Address
Mawia Karkoutly, Damascus University, Mazzeh Highway, Damascus, Syria
Country
Syrian Arab Republic
Secondary sponsor category [1] 315345 0
Individual
Name [1] 315345 0
Nada Bshara
Address [1] 315345 0
Nada Bshara, Damascus University, Mazzeh Highway, Damascus, Syria
Country [1] 315345 0
Syrian Arab Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312744 0
Institutional Review Board at Damascus University
Ethics committee address [1] 312744 0
Damascus University, Mazzeh Highway, Damascus, Syria
Ethics committee country [1] 312744 0
Syrian Arab Republic
Date submitted for ethics approval [1] 312744 0
Approval date [1] 312744 0
14/12/2022
Ethics approval number [1] 312744 0

Summary
Brief summary
Dental plaque accumulation is a common problem in toddlers. A randomized controlled trial was conducted to compare the efficacy of CHX gel and PVP-I solution in suppressing dental plaque regrowth in toddlers. The study included forty-five healthy toddlers aged 24-36 months who were randomly assigned to three groups. The first group received a placebo (distilled water (DW)) (negative control). The second group received topical CHX gel (0.2% w/v) (positive control). The third group received topical PVP-I solution (10% w/v). Plaque accumulation was measured at the baseline (t0), after three days (t1), and after 7 days (t2) using the Turesky modified Quigley-Hein plaque index (TMQHPI). Oral hygiene practices were prohibited during the trial period.
CHX and PVP-I efficacy lasted only for three days, and PVP-I was not superior to CHX in terms of plaque control in toddlers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125754 0
Dr Mawia Karkoutly
Address 125754 0
Mawia Karkoutly, Damascus University, Mazzeh Highway, Damascus, Syria
Country 125754 0
Syrian Arab Republic
Phone 125754 0
+963992647528
Fax 125754 0
Email 125754 0
mawiamaherkarkoutly@hotmail.com
Contact person for public queries
Name 125755 0
Dr Mawia Karkoutly
Address 125755 0
Mawia Karkoutly, Damascus University, Mazzeh Highway, Damascus, Syria
Country 125755 0
Syrian Arab Republic
Phone 125755 0
+963992647528
Fax 125755 0
Email 125755 0
mawiamaherkarkoutly@hotmail.com
Contact person for scientific queries
Name 125756 0
Dr Mawia Karkoutly
Address 125756 0
Mawia Karkoutly, Damascus University, Mazzeh Highway, Damascus, Syria
Country 125756 0
Syrian Arab Republic
Phone 125756 0
+963992647528
Fax 125756 0
Email 125756 0
mawiamaherkarkoutly@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Demographic data
Outcomes
When will data be available (start and end dates)?
currently available with no end date
Available to whom?
Editors/reviewers
None has reviewed or edited research publications yet.
Available for what types of analyses?
Descriptive (frequencies, percentages)
How or where can data be obtained?
on a reasonable request by emailing the principal investigator (mawiamaherkarkoutly@hotmail.com)


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.