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.

Study Overview

• Status: Completed
• Conditions: Oral Bacteria Levels in the Mouth
• Intervention / Treatment: Biological: 1% sesewanua extract mouthwash Arm; Biological: 2% sesewanua extract mouthwash; Biological: 4% sesewanua extract mouthwash Arm; Other: control/placebo (distilled water)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • North Sulawesi
    • Manado, North Sulawesi, Indonesia
      • Poltekkkes Kemenkes manado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Female students registered as residents of the female dormitory at the Manado Ministry of Health Polytechnic during the study period.
2. Age ≥17 years.
3. Willing to sign written informed consent.
4. Good oral and general health status based on initial screening (no acute oral infections, severely inflamed gums, or other oral conditions requiring immediate treatment).
5. Not currently using medications or therapies that could modulate oral flora (e.g., systemic antibiotics, therapeutic oral antiseptics) in the past 2 weeks.
6. Able to follow standardized oral hygiene protocols (able to brush and rinse as instructed).

Exclusion Criteria

1. Pregnancy or breastfeeding.
2. History of allergy to ingredients in mouthwash formulations (e.g., fragrances, parabens, sorbitol).
3. Use of antibiotics, antifungals, systemic steroids, or immunosuppressive medications in the 2 weeks before or during the study.
4. Invasive dental treatment or oral surgery in the past 1 month.
5. Systemic diseases that can affect saliva composition (e.g., uncontrolled diabetes, severe xerostomia, oral autoimmune diseases).
6. Active smoking or use of other tobacco products.
7. Non-compliance with protocols (e.g., failure to show up for sample collection).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral bacteria from respondent mouth; Participant mouth bacteria	Biological: 1% sesewanua extract mouthwash Arm; Participants who used 1% sesewanua extract mouthwash; Biological: 2% sesewanua extract mouthwash; participants who used 2% sesewanua extract mouthwash; Biological: 4% sesewanua extract mouthwash Arm; participants who used 4% sesewanua extract mouthwash; Other: control/placebo (distilled water); control/placebo (distilled water)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Collaborators and Investigators

• Sponsor: Poltekkes Kemenkes Manado

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2025
• Primary Completion (Actual): November 25, 2025
• Study Completion (Actual): November 25, 2025

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Herbal; Oral Hygiene; Mouthwash; Oral Bacteria; Oral Diseases
• Other Study ID Numbers: IRB-2025-0143; LB/11/2334/Fund/2025 (Other Grant/Funding Number: Poltekkes Manado)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No