NCT06711263

Brief Summary

Herbal medicine has been used for thousands of years. Traditional herbal medicine is used by an estimated 80% of the world's population for primary health care. Herbal treatments have gained popularity as a dietary supplement for illness prevention and as an alternative/complementary therapy in recent years. Herbal remedies come in a wide variety of forms and can be found on the market all over the world.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

November 26, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

December 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

November 26, 2024

Last Update Submit

November 28, 2024

Conditions

Keywords

plaquegingival bleedingresveratrolmiswaktea tree oilchlorhexidine

Outcome Measures

Primary Outcomes (1)

  • plaque score

    To assess the plaque score

    From Baseline-pre-intervention to the end of treatment at 4 weeks

Secondary Outcomes (1)

  • gingival bleeding score

    from pre-intervention to the end of the treatment at 4 weeks

Study Arms (4)

chlorhexidine

EXPERIMENTAL

Mouthwash will be used for these participants

Other: Mouthwash Product

Tea tree oil

ACTIVE COMPARATOR

Participants will use the mouthwash and plaque and gingival bleeding indice will be recorded at baseline, after 2 weeks and after 4 weeks

Other: Mouthwash Product

Reseverotriol

ACTIVE COMPARATOR

Participants will use the mouthwash and plaque and gingival bleeding indice will be recorded at baseline, after 2 weeks and after 4 weeks

Other: Mouthwash Product

Miswak

ACTIVE COMPARATOR

Participants will use the mouthwash and plaque and gingival bleeding indice will be recorded at baseline, after 2 weeks and after 4 weeks

Other: Mouthwash Product

Interventions

* In the Initial Visit-Baseline, and subsequent visits, participants will be called in the morning. Morning hours will be chosen for examination, as it will reduce the risk of bias and also help in quantifying results. plaque and gingival scores will be recorded and the First herbal mouthwashes will be given, participants will also be provided new tooth-brushes (Oral B-soft). * They will be asked to follow their routine oral hygiene habits. They will be asked to come back after 2 weeks for plaque and gingival bleeding scores recording for the second visit and again after 2weeks post the second visit for the third and final visit to record their plaque and gingival bleeding scores.

Also known as: chlorhexidine, resverotriol, miswak, tea tree oil
MiswakReseverotriolTea tree oilchlorhexidine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who are medically fit
  • Patients with gingival inflammation not progressed into periodontitis (AAP classification
  • Patients between the age of 18-60 years

You may not qualify if:

  • Patients who are medically compromised
  • Patient who have undergone a periodontal therapy for the past 3 months
  • Patients who are healthy but have been using herbal mouthwashes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Plaque, AmyloidGingival Hemorrhage

Interventions

ChlorhexidineTea Tree Oil

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsOral HemorrhageMouth DiseasesStomatognathic DiseasesGingival DiseasesPeriodontal DiseasesHemorrhagePathologic Processes

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsOils, VolatileOilsLipidsPlant OilsPlant PreparationsBiological ProductsComplex Mixtures

Central Study Contacts

sudhir Rama Varma, MDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants are masked
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: In the Initial Visit-Baseline, and subsequent visits, participants will be called in the morning. Morning hours will be chosen for examination, as it will reduce the risk of bias and also help in quantifying results. plaque and gingival scores will be recorded and the First herbal mouthwashes will be given, participants will also be provided new tooth-brushes (Oral B-soft).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 26, 2024

First Posted

December 2, 2024

Study Start

December 20, 2024

Primary Completion

February 20, 2025

Study Completion

March 20, 2025

Last Updated

December 2, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share