Oral Bacteria Levels in the Mouth
Conditions
Keywords
Herbal, Mouthwash, Oral Bacteria, Oral Diseases, Oral Hygiene
Brief 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. 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.
Interventions
BIOLOGICAL1% sesewanua extract mouthwash Arm
Participants who used 1% sesewanua extract mouthwash
BIOLOGICAL2% sesewanua extract mouthwash
participants who used 2% sesewanua extract mouthwash
BIOLOGICAL4% sesewanua extract mouthwash Arm
participants who used 4% sesewanua extract mouthwash
OTHERcontrol/placebo (distilled water)
control/placebo (distilled water)
Sponsors
Poltekkes Kemenkes Manado
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Streptococcus mutans colony counts (CFU/ml) in participants' oral samples between pre-intervention and post-intervention. Secondary Outcome | 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; %): | 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): | 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. |
Countries
Indonesia
Outcome results
None listed