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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Oral hygiene

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

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]

Behaviour

Intervention code [2]

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]

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]

Baseline and 4 weeks post-intervention.

Secondary outcome [1]

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]

Baseline and 4 weeks post-intervention.

Secondary outcome [2]

Bleeding on probing: the percentage of teeth surface numbers that are free from gingival bleeding — four surfaces per tooth.

Timepoint [2]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Saudi Arabia

State/province [1]

AlQassim, Buraidah

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Nabeel Almotairy

Address [1]

Department of Orthodontics and Pediatric Dentistry College of Dentistry, Qassim University P.O.Box 4732, 51412 Buraidah Saudi Arabia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Committee of Research Ethics at Qassim University

Ethics committee address [1]

P.O.Box 6640, Buraidah 51452

Ethics committee country [1]

Saudi Arabia

Date submitted for ethics approval [1]

01/06/2021

Approval date [1]

23/06/2021

Ethics approval number [1]

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

A/Prof 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

Phone

+966502022504

Fax

[email protected]

Contact person for public queries

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

Phone

+966502022504

Fax

[email protected]

Contact person for scientific queries

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

Phone

+966502022504

Fax

[email protected]

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: [email protected]
Tel: +966502022504

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
20173	Ethical approval					386476-(Uploaded-30-08-2023-07-39-04)-Study-related document.pdf

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.

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