Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000048583
Ethics application status
Approved
Date submitted
30/08/2023
Date registered
22/01/2024
Date last updated
22/01/2024
Date data sharing statement initially provided
22/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of viewing digital images of the severe consequences of poor oral hygiene on patients' adherence to good oral hygiene practice
Scientific title
Effectiveness of digital oral hygiene reinforcement on plaque score in healthy adults: A single-blind randomized controlled trial
Secondary ID [1] 310446 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral hygiene 331265 0
Condition category
Condition code
Oral and Gastrointestinal 328020 328020 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 experiment will be conducted by a dentist with minimum 2 years' experience.
A one-to-one 5 minute video-based presentation containing recommended brushing and flossing techniques WITH images displaying the consequences of poor oral hygiene will be presented,
After the end of the presentation, each participant will be asked if he/she understood the video-based instructions, and he/she will be given the chance for any clarifications.
The video-based presentation will be presented at the initial visit only. No video-based instructions will be presented at the second visit (after 4 weeks).
Intervention code [1] 326865 0
Behaviour
Intervention code [2] 327493 0
Prevention
Comparator / control treatment
The same dentist will do the same for the control group, except that they will be shown a one-to-one 5 minute video-based presentation containing recommended brushing and flossing techniques WITHOUT images displaying the consequences of poor oral hygiene.
After the end of the presentation, each participant will be asked if he/she understood the video-based instructions, and he/she will be given the chance for any clarifications.
The video-based presentation will be presented at the initial visit only. No video-based instructions will be presented at the second visit (after 4 weeks).
Control group
Active

Outcomes
Primary outcome [1] 335891 0
Plaque score: a modified O’Leary Index is used to define the number of surfaces free of plaque as a percentage of surfaces in the mouth following a rinse with a discolouring solution — six surfaces will be assessed per tooth.
Timepoint [1] 335891 0
Baseline and 4 weeks post-intervention.
Secondary outcome [1] 426140 0
Gingival bleeding index as follows:
Score Definition
0 no bleeding on probing
1 a single bleeding point
2 several bleeding points or thin line
3 interdental space filled with blood
Timepoint [1] 426140 0
Baseline and 4 weeks post-intervention.
Secondary outcome [2] 426141 0
Bleeding on probing: the percentage of teeth surface numbers that are free from gingival bleeding — four surfaces per tooth.
Timepoint [2] 426141 0
Baseline and 4 weeks post-intervention.

Eligibility
Key inclusion criteria
The participants should be healthy adult patients (18-40 years-old) who have at least 20 natural teeth and are willing to participate in this study and sign the consent forms.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
1) students studying medicine or dentistry
2) current dental or orthodontic treatment
3) acute or chronic immune disturbances
4) pregnancy
5) systemic diseases that could directly or indirectly inhibit optimum oral health maintenance, such as diabetes, known antibiotic treatments, smoking, and oral-related diseases (periodontitis)
6) insufficient Arabic language skills

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)
Group assignment: lottery in a sealed opaque box.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by a randomisation website (Randomization.com).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Package for the Social Sciences (SPSS) (version 23.0; SPSS Inc, Chicago, IL). The study will report the descriptive data about the participants' demographics (age, gender, tooth brushing habits, oral history, previous and current medications) and oral health-related parameters. The data normality of the measured parameters (PS, BI, and BOP) will be assessed using the Shapiro-Wilk test and histogram plots. If the data normality is verified, a paired t-test will be conducted to test the follow-up change in the oral health-related parameters during the two visits within each group. While one-way ANOVA test will be conducted to test the differences in oral health-related parameters between the two groups at baseline and 4-week follow-up. Post-hoc test will be conducted in significant ANOVA results. If data normality is rejected, alternative non-parametric tests will be conducted. A p-value of less than 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/04/2024
Actual
Date of last participant enrolment
Anticipated
7/06/2024
Actual
Date of last data collection
Anticipated
8/07/2024
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment outside Australia
Country [1] 25735 0
Saudi Arabia
State/province [1] 25735 0
AlQassim, Buraidah

Funding & Sponsors
Funding source category [1] 314699 0
Self funded/Unfunded
Name [1] 314699 0
Nabeel Almotairy
Country [1] 314699 0
Saudi Arabia
Primary sponsor type
Individual
Name
Nabeel Almotairy
Address
Department of Orthodontics and Pediatric Dentistry College of Dentistry, Qassim University P.O.Box 4732, 51412 Buraidah Saudi Arabia
Country
Saudi Arabia
Secondary sponsor category [1] 316671 0
None
Name [1] 316671 0
Address [1] 316671 0
Country [1] 316671 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313672 0
Committee of Research Ethics at Qassim University
Ethics committee address [1] 313672 0
P.O.Box 6640, Buraidah 51452
Ethics committee country [1] 313672 0
Saudi Arabia
Date submitted for ethics approval [1] 313672 0
01/06/2021
Approval date [1] 313672 0
23/06/2021
Ethics approval number [1] 313672 0
20-09-03

Summary
Brief summary
Background: Poor adherence to tooth brushing and flossing will lead to the accumulation of plaque and bacterial biofilm, resulting in gingival inflammation and dental demineralization. Besides, if kept untreated, poor oral hygiene will cause periodontal destruction, which perhaps progresses to dentition loss. Thus, effective oral hygiene (OH) instructions are essential for the prevention and maintenance of oral health.
Rationale: Previous OH strategies range between traditional verbal instructions to videotaped instructions, which showed similar effectiveness. Other recent strategy involves showing the patients the severe consequences of plaque and bacterial biofilm accumulation on oral health which showed promising results. Thus, an interesting question arises: Are the mere OH instructions delivered verbally or digitally enough, or should the poor OH consequences be highlighted?
Study objectives: To compare the differences in the adherence of optimum oral hygiene during video OH instructions with or without images displaying the consequences of poor OH. We hypothesized that the inclusion of digital images displaying poor OH's consequences would show no differences in patients’ oral hygiene adherence.
Methods: Forty-eight healthy participants will come during two visits and will be divided equally into two groups. Group 1 consists of 24 participants which they will be exposed to video OH instructions. Group 2 also consists of 24 healthy participants and will be exposed to video OH instructions but with images displaying the consequences of poor OH's. Routine participants’ demographic data along with patient’s plaque score, gingival bleeding index, and gingival bleeding on probing will be collected.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128962 0
A/Prof Nabeel Almotairy
Address 128962 0
Department of Orthodontics and Pediatric Dentistry
College of Dentistry, Qassim University
P.O.Box 4732, 51412 Buraidah
Saudi Arabia
Country 128962 0
Saudi Arabia
Phone 128962 0
+966502022504
Fax 128962 0
Email 128962 0
N.S.Almotairy@qu.edu.sa
Contact person for public queries
Name 128963 0
A/Prof Nabeel Almotairy
Address 128963 0
Department of Orthodontics and Pediatric Dentistry
College of Dentistry, Qassim University
P.O.Box 4732, 51412 Buraidah
Saudi Arabia
Country 128963 0
Saudi Arabia
Phone 128963 0
+966502022504
Fax 128963 0
Email 128963 0
N.S.Almotairy@qu.edu.sa
Contact person for scientific queries
Name 128964 0
A/Prof Nabeel Almotairy
Address 128964 0
Department of Orthodontics and Pediatric Dentistry
College of Dentistry, Qassim University
P.O.Box 4732, 51412 Buraidah
Saudi Arabia
Country 128964 0
Saudi Arabia
Phone 128964 0
+966502022504
Fax 128964 0
Email 128964 0
N.S.Almotairy@qu.edu.sa

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The study will publish the descriptive data about the participants' demographic data (age, gender, tooth brushing habits, oral history, previous and current medications) and oral health-related parameters.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
For reproduced studies and meta-analysis.
How or where can data be obtained?
Access subject to approvals by Principal Investigator:
Dr. Nabeel Almotairy
Department of Orthodontics and Pediatric Dentistry
College of Dentistry, Qassim University
P.O.Box 4732, 51412 Buraidah
Saudi Arabia
Email: N.S.Almotairy@qu.edu.sa
Tel: +966502022504


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20173Ethical approval    386476-(Uploaded-30-08-2023-07-39-04)-Study-related document.pdf



Results publications and other study-related documents

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