NCT03839719

Brief Summary

  • Periodontal disease- Inflammatory, Multifactorial, and Threshold disease. Periodontal disease is a highly prevalent dental disease, an almost 100% prevalence in developing countries.
  • Non-surgical periodontal includes scaling and root planing (SRP) an essential part of successful periodontal therapy.
  • The spread of infection through aerosol and splatter has long been considered one of the main reason for the possible transmission of infectious agents and their ill effects on The Health of patients and Dental Health care Professionals.
  • Aerosols are generated during Tooth preparation/Rotary instrument/ air abrasion/Air-water syringe, Ultrasonic scaler, and while doing Air polishing.
  • Studies have also reported an association of these aerosols with Respiratory infections, Ophthalmic and Skin infections, Tuberculosis, and Hepatitis B. current research suggests that having patients use an antimicrobial rinse before treatment may decrease microbial aerosols.
  • Chlorhexidine mouthwash is regarded as Gold Standard mouthwash but, have many local side effects including have many local side effects including extrinsic tooth and tongue brown staining, taste disturbance, enhanced supragingival calculus formation, less commonly, desquamation of oral mucosa, and even liver damage in rats.
  • In the emerging era of pharmaceuticals, herbal medicines with their naturally occurring active ingredients offer a gentle and enduring way for the restoration of health by the least harmful method.
  • Ocimum Sanctum (Tulsi) is known as THE QUEEN OF HERBS effective in reducing plaque accumulation, gingival inflammation, and bleeding \& has no side effects as compared to Chlorhexidine. Very few studies which can be counted on fingers have been conducted worldwide in this direction, globally showing their beneficial effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

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

January 9, 2019

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 1, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2019

Completed
Last Updated

June 26, 2019

Status Verified

June 1, 2019

Enrollment Period

4 months

First QC Date

February 1, 2019

Last Update Submit

June 25, 2019

Conditions

GingivitisPeriodontitisAerosol DiseaseGingival DiseasePeriodontal Diseases

Keywords

GingivitisAerosolOcimum sanctumMouth rinseSRPChlorhexidine mouthrinsePeriodontitis

Outcome Measures

Primary Outcomes (1)

  • Counting of the colony-forming units (CFU)

    Preformed 10% blood agar plates were used which were incubated at 37°C for 48 hr after collecting the sample. Counting of the colony-forming units (CFU) was performed by the microbiologist, who was blinded regarding the time of exposure and location of agar plate. The microbial counting was done after that.

    Up to 48 hr

Study Arms (3)

Group OC

EXPERIMENTAL

Ocimum sanctum (OC) is a natural herb which is known for its broad spectrum medicinal properties. Ocimum sanctum is also listed by the U.S. FDA as an herb Generally Recognized As Safe (GRAS) for its intended use as a therapeutic herb. Pharmacological constitutes present in the extract are eugenol, Urosolic acid, Carvacrol, linalool , limatrol, caryophyllene, and methyl carvicol. The literature showed that Ocimum sanctum extract has significant anti-gingivitis and anti-inflammatory effect as mouthrinse. Other Names: Tulsi Holy Basil

Procedure: Group OCProcedure: Group CHX

Group CHX

ACTIVE COMPARATOR

Chlorhexidine Gluconate (C34H54Cl2N10O14) is a bisbiguanide formulation with cationic properties. A literature review, highlighting chlorhexidine as not only a plaque control agent but also as an effective antimicrobial agent and its wider application in a variety of oral disorders in various formulations. As an antimicrobial agent, chlorhexidine is effective in vitro against both Gram-positive and Gram-negative bacteria including aerobes and anaerobes and yeasts and fungi. The digluconate of chlorhexidine (1:6Di 4' chlorophenyl-diguani-dohexane) is a synthetic antimicrobial drug which has been widely used as a broad spectrum antiseptic. Other Names: Chlorhexidine

Procedure: Group OCProcedure: Group CHX

Group PI

PLACEBO COMPARATOR

Group PI: Placebo (Distilled water) as the mouthrinse. Placebo (Distilled water) 10 ml is used as mouthrinse. Distilled water is commonly used as an excipient in a variety of drugs and it is also widely used as a placebo. Ultrasonic scaling was done in the 1st and 4th quadrant without any mouth rinse (placebo mouthrinse) and fall out samples were collected in the blood agar plates kept at a distance of 0.5 m and 1 m from the oral cavity. Treatment was carried out by placing 03 sterile agar plates uncovered at pre-designated sites to collect samples of aerosolized bacteria.

Procedure: Group PI

Interventions

Group PIPROCEDURE

Before rinsing with the mouthrinse, Ultrasonic scaling was done in the 1st and 4th quadrant without any mouth rinse (placebo mouthrinse) and fall out samples were collected in the blood agar plates kept at a distance of 0.5 m and 1 m from the oral cavity.

Also known as: mouthrinse followed by Ultrasonic scaling
Group PI
Group OCPROCEDURE

After ultrasonic scaling of the 1st and 4th quadrant minimum 30min interval maintained. After interval of 30min rinsing the mouth with the either OC/CHX/Placebo (OC= Ocimum sanctum mouthrinse, CHX=Chlorhexidine Gluconate mouthrinse) mouthrinse) done for 60s, Ultrasonic scaling was again done in the 2nd and 3rd quadrant and fall out samples were collected in the newly placed blood agar plates kept at 0.5 m and 1 m away from the patient.

Also known as: mouthrinse followed by Ultrasonic scaling
Group CHXGroup OC
Group CHXPROCEDURE

After ultrasonic scaling of the 1st and 4th quadrant minimum 30min interval maintained. After interval of 30min rinsing the mouth with the either OC/CHX/Placebo (OC= Ocimum sanctum mouthrinse, CHX=Chlorhexidine Gluconate mouthrinse) mouthrinse) done for 60s, Ultrasonic scaling was again done in the 2nd and 3rd quadrant and fall out samples were collected in the newly placed blood agar plates kept at 0.5 m and 1 m away from the patient.

Also known as: Mouthrinse followed by Ultrasonic scaling
Group CHXGroup OC

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.
  • Patient having ≥ 20 teeth.
  • Patients 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.
  • Patients on anti-inflammatory, perioceutics, antibiotics, steroids, cytotoxic and drugs since 03 months.
  • Patients who have known allergy to the material used for the study.
  • Pregnant and lactating mothers.
  • Patients had undergone any kind of nonsurgical and/or surgical periodontal therapy earlier, in the past 6 months.
  • Tobacco users (smoke and smokeless) and alcoholics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of periodontology, GDC Indore

Indore, Madhu Pradesh, 452001, India

Location

Related Publications (2)

  • Gupta G, Mitra D, Ashok KP, Gupta A, Soni S, Ahmed S, Arya A. Efficacy of preprocedural mouth rinsing in reducing aerosol contamination produced by ultrasonic scaler: a pilot study. J Periodontol. 2014 Apr;85(4):562-8. doi: 10.1902/jop.2013.120616. Epub 2013 Jul 15.

    PMID: 23855840RESULT

  • Reddy S, Prasad MG, Kaul S, Satish K, Kakarala S, Bhowmik N. Efficacy of 0.2% tempered chlorhexidine as a pre-procedural mouth rinse: A clinical study. J Indian Soc Periodontol. 2012 Apr;16(2):213-7. doi: 10.4103/0972-124X.99264.

    PMID: 23055587RESULT

Related Links

MeSH Terms

Conditions

GingivitisPeriodontitisGingival DiseasesPeriodontal Diseases

Condition Hierarchy (Ancestors)

InfectionsMouth DiseasesStomatognathic Diseases

Study Officials

  • DR.MADHU S. RATRE, M.D.S.

    Govt. college of dentistry, Indore

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
This single-center, double-masked, placebo-controlled study was conducted over a period of 02 months. The participants and investigator are blinded about mouthrinse use and assigned quadrant. Then Ultrasonic scaling was done in the 1st and 4th quadrant without any mouth rinse and Ultrasonic scaling is done in the 2nd and 3rd quadrant by giving either OC/CHX/Placebo mouth rinse
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Ultrasonic scaling was done in the 1st and 4th quadrant without any mouth rinse and fall out samples were collected in the blood agar plates kept at a distance of 0.5 m and 1 m from the oral cavity. After ultrasonic scaling of the 1st and 4th quadrant minimum 30min interval maintained. After interval of 30min rinsing the mouth with the either OC/CHX/Placebo (OC= Ocimum sanctum mouthrinse, CHX=Chlorhexidine Gluconate mouthrinse) mouthrinse) done for 60s, Ultrasonic scaling was again done in the 2nd and 3rd quadrant and fall out samples were collected in the newly placed blood agar plates kept at 0.5 m and 1 m away from the patient. Treatment was carried out by placing 03 sterile agar plates uncovered at pre-designated sites to collect samples of aerosolized bacteria After ultrasonic scaling of the 1st and 4th quadrant and after 2nd and 3rd quadrant.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 1, 2019

First Posted

February 15, 2019

Study Start

January 9, 2019

Primary Completion

April 26, 2019

Study Completion

May 25, 2019

Last Updated

June 26, 2019

Record last verified: 2019-06

Locations

IN(1)