NCT03474146

Brief Summary

Chlorhexidine is considered as gold standard for its antiplaque and antigingivitis efficacy till date but it has got many side effects. So it is need of the hour that investigators will find some substitute having similar antiplque and antigingivitis efficay but have less or no adverse effects. so in this study investigators planned to do "Comparative evaluation of antiplaque and antigingivitis efficacy of ocimum sanctum (tulsi) extract mouthrinse with 0.12% chlorhexidine mouthrinse.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2017

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

3 months

First QC Date

March 8, 2018

Last Update Submit

April 16, 2018

Conditions

Periodontal DiseasesGingivitisPeriodontitis

Keywords

MouthrinseOcimum sanctumPeriodontal DiseasesTulsi

Outcome Measures

Primary Outcomes (1)

  • Modified Gingival Index

    The Modified Gingival Index (Lobene, Weatherford, Ross, Lamm, 1986) was recorded based on following criteria: 0 - Absence of inflammation. 1 - Mild inflammation or with slight changes in color and texture but, not in all portions of marginal or papillary gingiva. 2 - Mild inflammation, such as the preceding criteria, in all portions of marginal or papillary gingiva. 3 - Moderate, bright surface inflammation, erythema, edema, and/or hypertrophy of marginal or papillary gingiva. 4 - Severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration. Modified Gingival Index = Total score of all teeth / no. of sites

    Change from baseline Gingival index at 03 weeks

Secondary Outcomes (1)

  • Modified Plaque Index

    Change from baseline Plaque index at 03 weeks

Other Outcomes (2)

  • Minimum Inhibitory Concentration (MIC)

    Up to 24 hours

  • Minimum bactericidal concentration (MBC)

    Up to 24 hours

Study Arms (3)

Ocimum sanctum extract as mouthrinse

EXPERIMENTAL

10ml mouthrinse was rinsed for 60sec twice a daily for 03 weeks.

Other: Ocimum sanctum

Chlorhexidine Gluconate as mouthrinse

ACTIVE COMPARATOR

10ml mouthrinse was rinsed for 60sec twice a daily for 03 weeks.

Other: Chlorhexidine Gluconate

Propylene Glycol as mouthrinse

PLACEBO COMPARATOR

10ml mouthrinse was rinsed for 60sec twice a daily for 03 weeks.

Other: Propylene Glycol

Interventions

Ocimum sanctumOTHER

Ocimum sanctum (known as Tulsi, Holy basil) is natural herb which is known for its broad spectrum medicinal properties. Ocimum sanctum is one of the best examples of Ayurveda's holistic lifestyle approach to health. It is also been well practiced in traditional medicine in India and south Asian region. Literature showed that Ocimum sanctum extract have significant anti-gingivitis and anti-inflammatory effect as mouthrinse.

Also known as: Tulsi, Holy Basil
Ocimum sanctum extract as mouthrinse
Chlorhexidine GluconateOTHER

Chlorhexidine Gluconate (C34H54Cl2N10O14) is a bisbiguanide formulation with cationic properties. Chlorhexidine over a period of over 40 years has been thoroughly investigated and successfully used as plaque control agent in dental practice. A literature review, highlighting chlorhexidine as not only a plaque control agent but also as an effective antimicrobial agent and its wider application in variety of oral disorders in various formulations.

Also known as: Chlorhexidine
Chlorhexidine Gluconate as mouthrinse
Propylene GlycolOTHER

Propylene glycol or 1,2-dihydroxypropane or 1,2-propanediol, is a clear, colourless, viscous, practically odourless liquid with a density of 1.038 g/cm³ at 20 °C and a molecular weight of 76.095. It is miscible with water, acetone and chloroform. It is miscible in water. Propylene glycol is commonly used as an excipient in a variety of drugs and it is also authorised in food products and cosmetics.

Propylene Glycol as mouthrinse

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Cases with generalized chronic gingivitis or cases with mild generalized chronic periodontitis patients of any sex.
  • Systemically healthy individuals.
  • Participants having \>20 teeth.
  • Participants in the age group of 18-40 years, who abide by approved protocol guidelines, and are ready to give written informed consent.

You may not qualify if:

  • Any known systemic disease which has effects on periodontium such as diabetes, cardiovascular, cancer etc.
  • Participants on anti-inflammatory, perioceutics, antibiotics, steroids, cytotoxic and drugs since 03 months.
  • Participants who have known allergy to material used for the study.
  • Pregnant and lactating mothers.
  • Participants had undergone any kind of nonsurgical and/or surgical periodontal therapy earlier, in past 6 months.
  • Tobacco users (smoke and smokeless) and alcoholics.
  • Participants wearing any form of intraoral prosthesis or appliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GCD Indore

Indore, Madhya Pradesh, 452001, India

Location

Related Publications (3)

  • Gupta D, Bhaskar DJ, Gupta RK, Karim B, Jain A, Singh R, Karim W. A randomized controlled clinical trial of Ocimum sanctum and chlorhexidine mouthwash on dental plaque and gingival inflammation. J Ayurveda Integr Med. 2014 Apr;5(2):109-16. doi: 10.4103/0975-9476.131727.

    PMID: 24948862BACKGROUND

  • Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. No abstract available.

    PMID: 3485495BACKGROUND

  • Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.

    PMID: 5264376BACKGROUND

MeSH Terms

Conditions

Periodontal DiseasesGingivitisPeriodontitis

Interventions

holy basil leaf extractchlorhexidine gluconateChlorhexidinePropylene Glycol

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesInfectionsGingival Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsPropylene GlycolsGlycolsAlcohols

Study Officials

  • Dr. Subhash Garg, M.D.S.

    Govt. College of Dentistry, Indore, Madhya pradesh, India

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate student

Study Record Dates

First Submitted

March 8, 2018

First Posted

March 22, 2018

Study Start

April 12, 2017

Primary Completion

July 22, 2017

Study Completion

July 31, 2017

Last Updated

April 17, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)