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| ID | Type | Description | Link |
|---|---|---|---|
| LB/11/2334/Fund/2025 | Other Grant/Funding Number | Poltekkes Manado |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral bacteria from respondent mouth | Experimental | Participant mouth bacteria |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% sesewanua extract mouthwash Arm | Biological | Participants who used 1% sesewanua extract mouthwash |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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. | 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). |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poltekkkes Kemenkes manado | Manado | North Sulawesi | Indonesia |
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).
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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.
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| 2% sesewanua extract mouthwash | Biological | participants who used 2% sesewanua extract mouthwash |
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| 4% sesewanua extract mouthwash Arm | Biological | participants who used 4% sesewanua extract mouthwash |
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| control/placebo (distilled water) | Other | control/placebo (distilled water) |
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