Oral Bacteria Levels in the MouthNCT07434882
The Efficacy of Sesewanua (Clerodendrum Fragrans Wild) Mouthwash in Reducing Oral Bacteria Growth: A Quasi-Experimental Study in Nursing Practice
A study testing 1% sesewanua extract mouthwash Arm, 2% sesewanua extract mouthwash and 4% sesewanua extract mouthwash Arm in people with Oral Bacteria Levels in the Mouth, run by Poltekkes Kemenkes Manado at 1 site in Indonesia.
Trial summary
Background and Objectives: This study investigated the antibacterial efficacy of Sesewanua (Clerodendrum fragrans Wild) extract as a mouthwash alternative to mitigate oral bacteria, particularly Streptococcus mutans. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Oral Bacteria Levels in the Mouth
- What is being tested?
- 1% sesewanua extract mouthwash Arm, 2% sesewanua extract mouthwash and 4% sesewanua extract mouthwash Arm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 19 Jun 2025to 25 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female students registered as residents of the female dormitory at the Manado Ministry of Health Polytechnic during the study period.
- Age ≥17 years.
- Willing to sign written informed consent.
- Good oral and general health status based on initial screening (no acute oral infections, severely inflamed gums, or other oral conditions requiring immediate treatment).
- Not currently using medications or therapies that could modulate oral flora (e.g., systemic antibiotics, therapeutic oral antiseptics) in the past 2 weeks.
- Able to follow standardized oral hygiene protocols (able to brush and rinse as instructed).
Who cannot join
- Pregnancy or breastfeeding.
- History of allergy to ingredients in mouthwash formulations (e.g., fragrances, parabens, sorbitol).
- Use of antibiotics, antifungals, systemic steroids, or immunosuppressive medications in the 2 weeks before or during the study.
- Invasive dental treatment or oral surgery in the past 1 month.
- Systemic diseases that can affect saliva composition (e.g., uncontrolled diabetes, severe xerostomia, oral autoimmune diseases).
- Active smoking or use of other tobacco products.
- Non-compliance with protocols (e.g., failure to show up for sample collection).
Trial locations and contacts
1 site in 1 country.
About this study
Background and Objectives: This study investigated the antibacterial efficacy of Sesewanua (Clerodendrum fragrans Wild) extract as a mouthwash alternative to mitigate oral bacteria, particularly Streptococcus mutans.
Materials and Methods: A quasi-experimental design was employed with a cohort of 100 female students, divided into four groups to assess varying concentrations (1%, 2%, and 4%) of Sesewanua extract, along with a purified water control. The extraction process involved mechanical grinding followed by maceration with 70% ethanol to maximize the extraction of bioactive compounds. Microbiological analysis was conducted post-intervention to measure the reduction in bacterial counts.
- Conditions
- Oral Bacteria Levels in the Mouth
- Being tested
- 1% sesewanua extract mouthwash Arm, 2% sesewanua extract mouthwash, 4% sesewanua extract mouthwash Arm, control/placebo (distilled water)
- Keywords
- Herbal, Mouthwash, Oral Bacteria, Oral Diseases, Oral Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% sesewanua extract mouthwash ArmBiological
Participants who used 1% sesewanua extract mouthwash
2% sesewanua extract mouthwashBiological
participants who used 2% sesewanua extract mouthwash
4% sesewanua extract mouthwash ArmBiological
participants who used 4% sesewanua extract mouthwash
control/placebo (distilled water)Other
control/placebo (distilled water)
| Study group | Role | What they receive |
|---|---|---|
| Oral bacteria from respondent mouth | Experimental | Participant mouth bacteria Receives: Biological: 1% sesewanua extract mouthwash Arm; Biological: 2% sesewanua extract mouthwash; Biological: 4% sesewanua extract mouthwash Arm; Other: control/placebo (distilled water) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Streptococcus mutans colony counts (CFU/ml) in participants' oral samples between pre-intervention and post-intervention. Secondary Outcome
Outcome Measure 1 (Primary; continuous; CFU/mL):
Change in Streptococcus mutans colony counts (CFU/mL) in oral samples from baseline (pre-intervention) to end of treatment (post-intervention within 12 weeks). For each group (1%, 2%, 4%, placebo), within-group change will be evaluated using paired t-tests; results will be reported as mean (SD) CFU/mL at each time point and mean (SD) change.
Measured: Research timeline for a quasi-experimental study on the effectiveness of Sesewanua (Clerodendrum fragrans Wild) mouthwash in reducing the growth of Streptococcus mutans. Total duration: 12 weeks (3 months).
Outcome Measure 2 (Secondary A; continuous; %):
Participant-level percent reduction in S. mutans CFU/mL. Between-group differences in mean percent reduction will be tested using one-way ANOVA (with appropriate post-hoc comparisons if overall p<0.05).
Measured: Research timeline for a quasi-experimental study on the effectiveness of Sesewanua (Clerodendrum fragrans Wild) mouthwash in reducing the growth of Streptococcus mutans. Total duration: 12 weeks (3 months).
Outcome Measure 3 (Secondary B; categorical; proportion):
Clinically meaningful response rate, defined as achieving ≥50% reduction in CFU/mL from baseline to post-intervention.
Measured: Research timeline for a quasi-experimental study on the effectiveness of Sesewanua (Clerodendrum fragrans Wild) mouthwash in reducing the growth of Streptococcus mutans. Total duration: 12 weeks (3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start19 Jun 2025
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Bacteria Levels in the MouthStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study employed a randomized, controlled, parallel-group interventional model with allocation concealment and assessor blinding. Randomization was performed using a computer-generated sequence with block sizes of four to ensure balanced group sizes; allocation assignments were sealed in opaque envelopes opened by an independent coordinator. Participants and outcome assessors were blinded to group allocation; mouthwash bottles were identical and labeled by code. The intervention period lasted 14 days with baseline, day-7 (midpoint) and day-14 (endpoint) assessments to evaluate temporal effects. Adherence was monitored via daily logs and residual volume measurement; participants with \<80% adherence were analyzed per-protocol and sensitivity analyses included intention-to-treat with last-observation-carried-forward for missing data. Adverse events were recorded at each visit.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poltekkes Kemenkes Manado
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434882
- Sponsor's protocol ID
- IRB-2025-0143
- Other IDs
- LB/11/2334/Fund/2025
- Status last verified
- Feb 2026
- First submitted
- 19 Dec 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is contrary to the ethical principles agreed upon in this research, which state that all or part of the data may not be distributed anywhere except for publication purposes (requests from the journal).
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Sesewanua (Clerodendrum Fragrans Wild) Mouthwash in Reducing Oral Bacteria Growth: A Quasi-Experimental Study in Nursing Practice
- ClinicalTrials.gov ID
- NCT07434882
- Acronym / sponsor ID
- IRB-2025-0143
- Conditions
- Oral Bacteria Levels in the Mouth
- Keywords
- Herbal, Mouthwash, Oral Bacteria, Oral Diseases, Oral Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Poltekkes Kemenkes ManadoUniversity, hospital or other
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 27 Feb 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.
Background and Objectives: This study investigated the antibacterial efficacy of Sesewanua (Clerodendrum fragrans Wild) extract as a mouthwash alternative to mitigate oral bacteria, particularly Streptococcus mutans.
Materials and Methods: A quasi-experimental design was employed with a cohort of 100 female students, divided into four groups to assess varying concentrations (1%, 2%, and 4%) of Sesewanua extract, along with a purified water control. The extraction process involved mechanical grinding followed by maceration with 70% ethanol to maximize the extraction of bioactive compounds. Microbiological analysis was conducted post-intervention to measure the reduction in bacterial counts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study employed a randomized, controlled, parallel-group interventional model with allocation concealment and assessor blinding. Randomization was performed using a computer-generated sequence with block sizes of four to ensure balanced group sizes; allocation assignments were sealed in opaque envelopes opened by an independent coordinator. Participants and outcome assessors were blinded to group allocation; mouthwash bottles were identical and labeled by code. The intervention period lasted 14 days with baseline, day-7 (midpoint) and day-14 (endpoint) assessments to evaluate temporal effects. Adherence was monitored via daily logs and residual volume measurement; participants with <80% adherence were analyzed per-protocol and sensitivity analyses included intention-to-treat with last-observation-carried-forward for missing data. Adverse events were recorded at each visit.
| Arm | Type | Receives |
|---|---|---|
| Oral bacteria from respondent mouth | Experimental | Biological: 1% sesewanua extract mouthwash Arm, Biological: 2% sesewanua extract mouthwash, Biological: 4% sesewanua extract mouthwash Arm, Other: control/placebo (distilled water)Participant mouth bacteria |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Female students registered as residents of the female dormitory at the Manado Ministry of Health Polytechnic during the study period.
- Age ≥17 years.
- Willing to sign written informed consent.
- Good oral and general health status based on initial screening (no acute oral infections, severely inflamed gums, or other oral conditions requiring immediate treatment).
- Not currently using medications or therapies that could modulate oral flora (e.g., systemic antibiotics, therapeutic oral antiseptics) in the past 2 weeks.
Key exclusion criteria (7 listed)
- Pregnancy or breastfeeding.
- History of allergy to ingredients in mouthwash formulations (e.g., fragrances, parabens, sorbitol).
- Use of antibiotics, antifungals, systemic steroids, or immunosuppressive medications in the 2 weeks before or during the study.
- Invasive dental treatment or oral surgery in the past 1 month.
- Systemic diseases that can affect saliva composition (e.g., uncontrolled diabetes, severe xerostomia, oral autoimmune diseases).
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 |
|---|---|---|
| 1% sesewanua extract mouthwash ArmParticipants who used 1% sesewanua extract mouthwash | Biological | Oral bacteria from respondent mouth |
| 2% sesewanua extract mouthwashparticipants who used 2% sesewanua extract mouthwash | Biological | Oral bacteria from respondent mouth |
| 4% sesewanua extract mouthwash Armparticipants who used 4% sesewanua extract mouthwash | Biological | Oral bacteria from respondent mouth |
| control/placebo (distilled water)control/placebo (distilled water) | Other | Oral bacteria from respondent mouth |
Primary outcome
Change in Streptococcus mutans colony counts (CFU/ml) in participants' oral samples between pre-intervention and post-intervention. Secondary Outcome
Time frame: Research timeline for a quasi-experimental study on the effectiveness of Sesewanua (Clerodendrum fragrans Wild) mouthwash in reducing the growth of Streptococcus mutans. Total duration: 12 weeks (3 months).
Outcome Measure 1 (Primary; continuous; CFU/mL): Change in Streptococcus mutans colony counts (CFU/mL) in oral samples from baseline (pre-intervention) to end of treatment (post-intervention within 12 weeks). For each group (1%, 2%, 4%, placebo), within-group change will be evaluated using paired t-tests; results will be reported as mean (SD) CFU/mL at each time point and mean (SD) change.
Outcome Measure 2 (Secondary A; continuous; %):
Time frame: Research timeline for a quasi-experimental study on the effectiveness of Sesewanua (Clerodendrum fragrans Wild) mouthwash in reducing the growth of Streptococcus mutans. Total duration: 12 weeks (3 months).
Participant-level percent reduction in S. mutans CFU/mL. Between-group differences in mean percent reduction will be tested using one-way ANOVA (with appropriate post-hoc comparisons if overall p<0.05).
Outcome Measure 3 (Secondary B; categorical; proportion):
Time frame: Research timeline for a quasi-experimental study on the effectiveness of Sesewanua (Clerodendrum fragrans Wild) mouthwash in reducing the growth of Streptococcus mutans. Total duration: 12 weeks (3 months).
Clinically meaningful response rate, defined as achieving ≥50% reduction in CFU/mL from baseline to post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No. This is contrary to the ethical principles agreed upon in this research, which state that all or part of the data may not be distributed anywhere except for publication purposes (requests from the journal).
Related trials for Oral Bacteria Levels in the Mouth
Not yet recruitingObservational study
Klotho Gene, Red Complex Bacteria and Periodontal Viruses in Patients With and Without Periodontitis and Acute Coronary Syndrome
Periodontal Diseases, Acute Coronary Artery Disease
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1% sesewanua extract mouthwash Arm, 2% sesewanua extract mouthwash and 4% sesewanua extract mouthwash Arm in people with Oral Bacteria Levels in the Mouth, run by Poltekkes Kemenkes Manado at 1 site in Indonesia.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Streptococcus mutans colony counts (CFU/ml) in participants' oral samples between pre-intervention and post-intervention. Secondary Outcome (time frame: Research timeline for a quasi-experimental study on the effectiveness of Sesewanua (Clerodendrum fragrans Wild) mouthwash in reducing the growth of Streptococcus mutans. Total duration: 12 weeks (3 months).). The study lists 3 primary outcomes in all. 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 27 Feb 2026.