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Completed

NCT Number: NCT07434882

The Efficacy of Sesewanua (Clerodendrum Fragrans Wild) Mouthwash in Reducing Oral Bacteria Growth: A Quasi-Experimental Study in Nursing Practice

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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Key information

Conditions

Oral Bacteria Levels in the Mouth

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Poltekkkes Kemenkes manado

Manado, North Sulawesi, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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).

Treatment and study plan

1% sesewanua extract mouthwash Arm

Biological

Participants who used 1% sesewanua extract mouthwash

2% sesewanua extract mouthwash

Biological

participants who used 2% sesewanua extract mouthwash

4% sesewanua extract mouthwash Arm

Biological

participants who used 4% sesewanua extract mouthwash

control/placebo (distilled water)

Other

control/placebo (distilled water)

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

Poltekkes Kemenkes Manado

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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