GingivitisSMILENCT07702383
A Multicentre Randomised Controlled Trial Evaluating the Efficacy of the SMILE™ Module for Improving Short-term Periodontal Outcomes, Compliance, and Acceptability Among Clinical Dental Students
A study testing SMILE Module and Conventional Toothbrushing Module in people with Gingivitis and Gingivitis; Chronic, run by National University of Malaysia at 4 sites in Malaysia.
Trial summary
This multicentre randomised controlled trial aims to evaluate the efficacy and safety of the SMILETM (Siwak Method for Integrated Lifestyle Enhancement) module in improving short-term periodontal outcomes, oral hygiene behaviour, and safe siwak practice among clinical dental students. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Gingivitis; Chronic
- What is being tested?
- SMILE Module and Conventional Toothbrushing Module
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 4 sitesMalaysia
- Study dates
- 1 Sep 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18 - 24 years
- Clinical dental students enrolled at one of the participating universities.
- Participants with a maximum diagnosed with plaque-induced gingivitis according to the 2018 Classification of Periodontal and Peri-Implant Diseases and Conditions, without clinical attachment loss attributable to periodontitis.
- Have adequate oral hygiene (ranging from good to fair; score from 0 to 1.9 according to Silness and Löe plaque index (1964)
- Possess at least 28 natural teeth.
- Able to understand study procedures and provide written informed consent.
- Willing to comply with all study procedures, intervention instructions, and follow-up assessments.
Who cannot join
- Using braces and dental prosthesis.
- Presence of systemic diseases known to influence oral and periodontal health
- Use of antibiotics for the last 3 months or any medication or known to affect oral and periodontal tissues or salivary flow
- Moderate or high dental caries risk
- Severe tooth malposition that may interfere with plaque assessment or oral hygiene procedures
- Participants presenting with moderate - severe dentin hypersensitivity
Show all 10Show fewer
- Participants with mucosa/ gingival trauma/recession and tooth wear
- Pregnancy or breastfeeding
- History of allergy or hypersensitivity to any material used in the study
- Cognitive, psychiatric, or physical conditions that may impair compliance with study procedures
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Shahida Mohd Said, BDS, MClinDent (Periodontology contact
Malaysia4 sites
Faculty of Dentistry, Universiti Kebangsaan Malaysia
Kuala Lumpur, Kuala Lumpur, 50300
Nik Madihah Nik Azis, Dclindent Periodontology, 0133410210, nikmadihah@ukm.edu.my
Faculty of Dentistry, Universiti Sains Islam Malaysia
Kuala Lumpur, Kuala Lumpur, 55100
0133410210, nikmadihah@ukm.edu.my
Kulliyyah of Dentistry, International Islamic University Malaysia
Kuantan, Pahang, 25200
Faculty of Dentistry, Universiti Teknologi MARA
Sungai Buloh, Selangor, 47000
About this study
Official title: The Efficacy of Integrated Siwak Practice (SMILE) Module on Short-term Periodontal Clinical Outcome, Compliance, and Acceptance.
This multicentre randomised controlled trial aims to evaluate the efficacy and safety of the SMILETM (Siwak Method for Integrated Lifestyle Enhancement) module in improving short-term periodontal outcomes, oral hygiene behaviour, and safe siwak practice among clinical dental students. Conventional toothbrushing will serve as the control intervention.
Eligible participants will be randomly assigned to either the SMILE intervention group or the conventional toothbrushing control group. Both groups will receive professional oral prophylaxis, standardised oral hygiene education, structured training according to their allocated intervention, and digital monitoring throughout the 21-day study period.
Read more
The study will assess changes in plaque accumulation, gingival health, and bleeding on probing, as well as participant compliance, behavioural outcomes, acceptability of the SMILE module, and intervention-related adverse events.
It is hypothesised that the SMILE module will effectively improve short-term periodontal outcomes, promote better compliance with the recommended oral hygiene practice, and achieve favourable acceptability while maintaining participant safety.
Read the detailed description
The participants will be recruited from four Malaysian universities and two Indonesian universities. Individuals who meet the eligibility criteria and provide written informed consent will undergo screening, oral examination, professional oral prophylaxis and any necessary dental treatment to establish a comparable baseline oral condition prior to randomisation.
Participants will then be randomly assigned in a 1:1 ratio to either the SMILE intervention group or the conventional toothbrushing control group using a computer-generated stratified randomisation sequence. Allocation concealment will be maintained through a centralised electronic allocation system. Outcome assessors and data analysts will remain blinded to group allocation.
The SMILE intervention group will receive a structured behavioural module delivered through the SMILE mobile application. The programme includes standardised instruction on siwak preparation, brushing technique, storage, recommended frequency of use, instructional videos, supervised hands-on practice, a standardised siwak kit, and daily monitoring using the mobile application with a paper logbook available as a contingency.
Participants in the control group will receive a structured conventional toothbrushing module following the same training schedule and monitoring procedures. A standardised toothbrush kit and the study application containing toothbrushing educational materials will be provided to ensure equivalent participant support and follow-up throughout the study.
Following completion of training, participants will perform their allocated oral hygiene practice for 21 consecutive days. Adherence to the assigned intervention will be monitored using the study application or the paper logbook when required. Clinical assessments will be conducted at baseline and at Day 21 by calibrated examiners using standardised periodontal examination procedures. The study is designed to determine the efficacy of the SMILE module under controlled conditions using conventional toothbrushing as the active control intervention.
- Conditions
- Gingivitis, Gingivitis; Chronic
- Being tested
- SMILE Module, Conventional Toothbrushing Module
- Keywords
- salvadora persica, siwak, miswak, Behavioural intervention, Randomised controlled trial,, oral hygiene, gingivitis, prevention, periodontal health
- Medical subject headings
- Gingivitis, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMILE ModuleBehavioural
The SMILE module intervention is a standardised behavioural oral hygiene programme designed to promote appropriate siwak use. The programme includes instruction on siwak preparation, brushing techniques, storage, replacement, frequency of use, and monitoring for safe siwak practice. Training is delivered through the SMILE mobile application using instructional videos and structured educational content, followed by supervised practical training.
Participants will receive a standardised siwak kit and will be instructed to perform siwak cleaning five times daily, corresponding to the recommended practice incorporated within the module. Adherence will be monitored throughout the 21-day intervention using the mobile application and/or daily logbook.
Conventional Toothbrushing ModuleBehavioural
Participants will receive standardised training in conventional toothbrushing through a structured educational module delivered using the study mobile application. The programme includes instruction on toothbrush preparation, brushing techniques, brushing duration, and toothbrush replacement recommendations. Participants will receive a standardised toothbrush kit and will be instructed to brush their teeth twice daily for approximately two minutes throughout the 21-day intervention period. Compliance will be monitored using mobile application and daily logbook employed for the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| SMILE Intervention Group | Experimental | Participants assigned to this group will receive the SMILE module behavioural intervention. The intervention includes standardised training in integrated siwak practice delivered through a mobile application, supervised hands-on practice, a standardised siwak kit, daily compliance monitoring, and supporting educational materials. Participants will perform integrated siwak practice according to the standardised protocol for 21 consecutive days. Receives: Behavioral: SMILE Module |
| Conventional Toothbrushing Control Group | Active comparator | Participants assigned to this group will receive standardised oral hygiene education based on conventional toothbrushing. They will undergo the same recruitment procedures, oral examination, prophylaxis, training duration, monitoring schedule, follow-up assessments, and data collection procedures as the intervention group. Receives: Behavioral: Conventional Toothbrushing Module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plaque Index (PI)
Plaque accumulation will be assessed using the Silness and Löe Plaque Index (1964), which evaluates the amount of plaque present at the gingival margin on four tooth surfaces using a 0-3 ordinal scale. Lower scores indicate better plaque control.
Measured: Baseline (day 0) and day 21 after randomisation
Secondary outcomes (1)
Change in Gingival Index (GI)
Gingival inflammation will be assessed using the Löe and Silness Gingival Index (1963), which evaluates gingival colour, consistency, and bleeding on gentle probing on a 0-3 ordinal scale. Lower scores indicate healthier gingival conditions.
Measured: Baseline (day 0) and day 21 after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion28 Apr 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the SMILE intervention group or the conventional toothbrushing control group. Both groups will receive the same study procedures, including professional oral prophylaxis, standardised oral hygiene education, structured training delivered through a dedicated mobile application, and identical monitoring throughout the 21-day intervention period. The intervention differs only in the oral hygiene tool and the intervention-specific training provided. Outcomes will be assessed at baseline and Day 21 using standardised clinical assessment procedures.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Sains Islam Malaysia, Universiti Teknologi Mara, International Islamic University Malaysia, Hasanuddin University
- Responsible party
- Principal investigator, Nik Madihah Nik Aziz, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702383
- Sponsor's protocol ID
- DD-2026-013
- Acronym
- SMILE
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Integrated Siwak Practice (SMILE) Module on Short-term Periodontal Clinical Outcome, Compliance, and Acceptance.
- ClinicalTrials.gov ID
- NCT07702383
- Acronym / sponsor ID
- SMILE / DD-2026-013
- Conditions
- Gingivitis, Gingivitis; Chronic
- Keywords
- salvadora persica, siwak, miswak, Behavioural intervention, Randomised controlled trial,, oral hygiene, gingivitis, prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- Universiti Sains Islam Malaysia, Universiti Teknologi Mara, International Islamic University Malaysia, Hasanuddin University
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 28 Apr 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicentre randomised controlled trial aims to evaluate the efficacy and safety of the SMILETM (Siwak Method for Integrated Lifestyle Enhancement) module in improving short-term periodontal outcomes, oral hygiene behaviour, and safe siwak practice among clinical dental students. Conventional toothbrushing will serve as the control intervention.
Eligible participants will be randomly assigned to either the SMILE intervention group or the conventional toothbrushing control group. Both groups will receive professional oral prophylaxis, standardised oral hygiene education, structured training according to their allocated intervention, and digital monitoring throughout the 21-day study period.
The study will assess changes in plaque accumulation, gingival health, and bleeding on probing, as well as participant compliance, behavioural outcomes, acceptability of the SMILE module, and intervention-related adverse events.
It is hypothesised that the SMILE module will effectively improve short-term periodontal outcomes, promote better compliance with the recommended oral hygiene practice, and achieve favourable acceptability while maintaining participant safety.
Detailed description
The participants will be recruited from four Malaysian universities and two Indonesian universities. Individuals who meet the eligibility criteria and provide written informed consent will undergo screening, oral examination, professional oral prophylaxis and any necessary dental treatment to establish a comparable baseline oral condition prior to randomisation.
Participants will then be randomly assigned in a 1:1 ratio to either the SMILE intervention group or the conventional toothbrushing control group using a computer-generated stratified randomisation sequence. Allocation concealment will be maintained through a centralised electronic allocation system. Outcome assessors and data analysts will remain blinded to group allocation.
The SMILE intervention group will receive a structured behavioural module delivered through the SMILE mobile application. The programme includes standardised instruction on siwak preparation, brushing technique, storage, recommended frequency of use, instructional videos, supervised hands-on practice, a standardised siwak kit, and daily monitoring using the mobile application with a paper logbook available as a contingency.
Participants in the control group will receive a structured conventional toothbrushing module following the same training schedule and monitoring procedures. A standardised toothbrush kit and the study application containing toothbrushing educational materials will be provided to ensure equivalent participant support and follow-up throughout the study.
Following completion of training, participants will perform their allocated oral hygiene practice for 21 consecutive days. Adherence to the assigned intervention will be monitored using the study application or the paper logbook when required. Clinical assessments will be conducted at baseline and at Day 21 by calibrated examiners using standardised periodontal examination procedures. The study is designed to determine the efficacy of the SMILE module under controlled conditions using conventional toothbrushing as the active control intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the SMILE intervention group or the conventional toothbrushing control group. Both groups will receive the same study procedures, including professional oral prophylaxis, standardised oral hygiene education, structured training delivered through a dedicated mobile application, and identical monitoring throughout the 21-day intervention period. The intervention differs only in the oral hygiene tool and the intervention-specific training provided. Outcomes will be assessed at baseline and Day 21 using standardised clinical assessment procedures.
| Arm | Type | Receives |
|---|---|---|
| SMILE Intervention Group | Experimental | Behavioral: SMILE ModuleParticipants assigned to this group will receive the SMILE module behavioural intervention. The intervention includes standardised training in integrated siwak practice delivered through a mobile application, supervised hands-on practice, a standardised siwak kit, daily compliance monitoring, and supporting educational materials. Participants will perform integrated siwak practice according to the standardised protocol for 21 consecutive days. |
| Conventional Toothbrushing Control Group | Active comparator | Behavioral: Conventional Toothbrushing ModuleParticipants assigned to this group will receive standardised oral hygiene education based on conventional toothbrushing. They will undergo the same recruitment procedures, oral examination, prophylaxis, training duration, monitoring schedule, follow-up assessments, and data collection procedures as the intervention group. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adults aged 18 - 24 years
- Clinical dental students enrolled at one of the participating universities.
- Participants with a maximum diagnosed with plaque-induced gingivitis according to the 2018 Classification of Periodontal and Peri-Implant Diseases and Conditions, without clinical attachment loss attributable to periodontitis.
- Have adequate oral hygiene (ranging from good to fair; score from 0 to 1.9 according to Silness and Löe plaque index (1964)
- Possess at least 28 natural teeth.
Key exclusion criteria (10 listed)
- Using braces and dental prosthesis.
- Presence of systemic diseases known to influence oral and periodontal health
- Use of antibiotics for the last 3 months or any medication or known to affect oral and periodontal tissues or salivary flow
- Moderate or high dental caries risk
- Severe tooth malposition that may interfere with plaque assessment or oral hygiene procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMILE ModuleThe SMILE module intervention is a standardised behavioural oral hygiene programme designed to promote appropriate siwak use. The programme includes instruction on siwak preparation, brushing techniques, storage, replacement, frequency of use, and monitoring for safe siwak practice. Training is delivered through the SMILE mobile application using instructional videos and structured educational content, followed by supervised practical training. Participants will receive a standardised siwak kit and will be instructed to perform siwak cleaning five times daily, corresponding to the recommended practice incorporated within the module. Adherence will be monitored throughout the 21-day intervention using the mobile application and/or daily logbook. | Behavioural | SMILE Intervention Group |
| Conventional Toothbrushing ModuleParticipants will receive standardised training in conventional toothbrushing through a structured educational module delivered using the study mobile application. The programme includes instruction on toothbrush preparation, brushing techniques, brushing duration, and toothbrush replacement recommendations. Participants will receive a standardised toothbrush kit and will be instructed to brush their teeth twice daily for approximately two minutes throughout the 21-day intervention period. Compliance will be monitored using mobile application and daily logbook employed for the intervention group. | Behavioural | Conventional Toothbrushing Control Group |
Primary outcome
Change in Plaque Index (PI)
Time frame: Baseline (day 0) and day 21 after randomisation
Plaque accumulation will be assessed using the Silness and Löe Plaque Index (1964), which evaluates the amount of plaque present at the gingival margin on four tooth surfaces using a 0-3 ordinal scale. Lower scores indicate better plaque control.
1 secondary outcome
Change in Gingival Index (GI)
Time frame: Baseline (day 0) and day 21 after randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shahida Mohd Said, BDS, MClinDent (Periodontology contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMILE Module and Conventional Toothbrushing Module in people with Gingivitis and Gingivitis; Chronic, run by National University of Malaysia at 4 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanah Pertiwisari, drg, M.KG (+60 10-5871-889, p154143@siswa.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plaque Index (PI) (time frame: Baseline (day 0) and day 21 after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.