NCT07401069

Brief Summary

Gingivitis is a very common oral disease that may progress to the more destructive periodontitis if not treated. As oral plaque is a key player in gingivitis, plaque control by professional scaling and oral hygiene measures represents the main line of treatment. Among the oral hygiene measures, using chlorhexidine mouthwash is considered the gold standard in mouthwashes. However, due to its side effects, a safer and more acceptable mouthwash is needed. Therefore, this study proposes mouthwashes made of infusion of natural herbs as an alternative.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_3

Timeline
2mo left

Started Feb 2026

Shorter than P25 for phase_3

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Feb 2026Jul 2026

First Submitted

Initial submission to the registry

February 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 1, 2026

Last Update Submit

February 6, 2026

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

  • plaque index (O'Leary et al., 1972)

    Plaque accumulation is tested on teeth with a probe. Number of sites having plaque accumulation will be divided by the total number of dental sites to get percentage of plaque accumulation.

    7 days

Secondary Outcomes (4)

  • Bleeding on probing

    7 days

  • Changes in clinical signs of inflammation (Armitage, 2004)

    7 days

  • Bleeding on brushing

    7 days

  • Patient's acceptance of the mouthwash

    7 days

Study Arms (2)

Chlorhexidine mouthwash

ACTIVE COMPARATOR
Drug: Chlorhexidine 0,12%

Herbal Homemade Mouthwash

EXPERIMENTAL
Drug: herbal Mouthwash

Interventions

Chlorhexidine 0,12%DRUG

chlorhexidine 0.12% mouthwash twice daily for 7 days

Chlorhexidine mouthwash
herbal MouthwashDRUG

Mouthwash made at home by boiling herbs in water and then saving the solution in a tightly closed container for daily use for 7 days

Herbal Homemade Mouthwash

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Plaque-induced gingivitis.

You may not qualify if:

  • Medically compromised.
  • History of medications.
  • Pregnant females.
  • Periapical involvement in teeth.
  • History of periodontal surgery.
  • If gingivitis was due to local factor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

February 1, 2026

First Posted

February 10, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02