NCT07822256

Brief Summary

Dental plaque is a sticky film of bacteria that forms on teeth and can lead to gum disease if it is not removed regularly. Brushing and flossing help control plaque, but many people also use a mouthwash to help clean areas that are hard to reach. This study compares two common types of mouthwash to see which one works better at reducing plaque: a mouthwash containing chlorhexidine (a medicated antibacterial ingredient) and a mouthwash containing essential oils (natural plant-based ingredients). Both are widely used, but they work in different ways and may cause different side effects. Sixty patients between the ages of 15 and 25 who had gum inflammation (gingivitis) took part. Half of the patients used the chlorhexidine mouthwash twice a day, and the other half used the essential oil mouthwash twice a day, for three months. Researchers measured the amount of plaque on each patient's teeth at the start of the study and again after three months, using a standard scoring method. They also recorded how well patients stuck to the mouthwash routine and any side effects they experienced, such as changes in taste, staining of the teeth, or a burning feeling in the mouth. The goal of this study is to help patients and dental care providers understand the benefits and drawbacks of each mouthwash, so they can choose the option that best fits their needs - whether that is stronger plaque control for a short period of time, or a milder option that may be more comfortable for longer-term use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2026

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2026

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

September 10, 2026

Last Update Submit

September 10, 2026

Conditions

Keywords

ChlorhexidineEssential OilsMouthwashDental PlaquePlaque Control

Outcome Measures

Primary Outcomes (1)

  • Change in Plaque Index Score

    Dental plaque was measured using the Silness and Löe Plaque Index on six selected teeth (16, 11, 26, 36, 31, and 46), scoring each tooth's distal, buccal, mesial, and lingual/palatal surfaces from 0 (no plaque) to 3 (abundant plaque in the gingival sulcus or margin).

    Baseline and 3 months

Secondary Outcomes (2)

  • Percentage Reduction in Plaque Index

    Baseline to 3 months

  • Incidence of Adverse Events

    3 months

Study Arms (2)

Chlorhexidine Mouthwash Group

ACTIVE COMPARATOR

Participants (n=30) used a 0.2% chlorhexidine gluconate mouthwash, gargling twice daily for 30 seconds, for a period of three months. All participants also received standard oral hygiene instructions, including brushing twice daily with a toothbrush and toothpaste.

Drug: Chlorhexidine Gluconate Mouthwash

Essential Oil Mouthwash Group

EXPERIMENTAL

Participants (n=30) used an essential oil-containing mouthwash twice daily for three months. Participants were instructed not to swallow the mouthwash and not to rinse their mouth with water after gargling. All participants also received standard oral hygiene instructions, including brushing twice daily with a toothbrush and toothpaste.

Drug: Essential Oil mouthwash

Interventions

A 0.2% chlorhexidine gluconate oral rinse used twice daily for 30 seconds over a three-month period. Chlorhexidine is a broad-spectrum antimicrobial agent with high substantivity, allowing it to bind to oral surfaces and provide sustained antiplaque action.

Chlorhexidine Mouthwash Group

An essential oil-containing oral rinse used twice daily over a three-month period. The formulation contains plant-derived antimicrobial compounds such as thymol and menthol, which act by disrupting microbial cell membrane integrity and reducing bacterial aggregation. Participants were instructed not to rinse with water after use.

Essential Oil Mouthwash Group

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 15-25 years
  • Diagnosis of gingivitis (inflammatory condition of the gums without attachment or bone loss)
  • Willingness to provide written informed consent (or parental/guardian consent plus assent, for minors)

You may not qualify if:

  • Periodontitis
  • Known allergy or hypersensitivity to chlorhexidine
  • Any systemic disease that could affect periodontal health
  • Current antibiotic therapy
  • Presence of anterior composite restorations
  • Visible enamel decalcification

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehman Medical Institute - RMI

Peshawar, Pakistan

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PG Trainee

Study Record Dates

First Submitted

September 10, 2026

First Posted

September 16, 2026

Study Start

February 3, 2026

Primary Completion

August 10, 2026

Study Completion

August 28, 2026

Last Updated

September 16, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations