Comparative Evaluation of Antiplaque and Antigingivitis Efficacy of Ocimum Sanctum (Tulsi) Extract

Periodontitis Clinical Trial

Official title:

"Comparative Evaluation of Antiplaque and Antigingivitis Efficacy of Ocimum Sanctum (Tulsi) Extract Mouthrinse With 0.12% Chlorhexidine Mouthrinse - an in Vitro and in Vivo Study."

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474146
• Other study ID #: 32/IEC/SS/2017
• Status: Completed
• Phase: N/A
• First received: March 8, 2018
• Last updated: April 16, 2018
• Start date: April 12, 2017
• Est. completion date: July 31, 2017

Study information

• Verified date: April 2018
• Source: Government College of Dentistry, Indore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Title:

"Comparative evaluation of antiplaque and antigingivitis efficacy of ocimum sanctum (tulsi) extract mouthrinse with 0.12% chlorhexidine mouthrinse - an in vitro and in vivo study."

Aims And Objectives:

1. To evaluate the antimicrobial activity of Ocimum sanctum (Tulsi) extract by Sensitivity testing, Minimum Inhibitory Concentration, Minimum Bactericidal Concentration, and Time kill curve -In Vitro study.

2. To evaluate the Antiplaque and Antigingivitis effect of the Ocimum sanctum (Tulsi) by recording Modified Gingival Index and Modified Plaque Index in patients with Chronic Generalized Gingivitis and Mild Chronic Generalized Periodontitis -In Vivo study.

3. Clinical evaluation and comparison of the Antiplaque and Antigingivitis effect of the Ocimum sanctum (Tulsi) with 0.12% Chlorhexidine and vehicle.

4. To see the topical beneficial and/or harmful side effects of Ocimum sanctum extract, if any.

Study Design:

Prospective randomized controlled Trial- Randomized Comparative Study

Methodology (Material & Methods):

The present study will have following parts:

1. Procurement of extract and formulation of mouthrinse: Ocimum sanctum (Tulsi) extract has been purchased from the ISO (International Organization for Standardization) Certified shop. The desired mouthrinse will be formulated under the guidance of Department of Pharmacology, Mahatma Gandhi Memorial Medical College, Indore (M.P.)

2. In vitro study: Sensitivity testing, Minimum Inhibitory Concentration (MIC) and Minimum Bactericidal Concentration (MBC), of Ocimum sanctum will be determined against following microorganisms: Porphyromonas gingivalis, Prevotella intermedia, Fusobacterium nucleatum, Aggregatibacter actinomycetemcomitans, Capnocytophaga, Tannerella forsythia, Pseudomonas aeruginosa, and other microorganisms.

3. In vivo study: This study has been planned and would be conducted in the Department of Periodontology, Govt. College of Dentistry, Indore, Madhya pradesh, India. In this study, participants with Chronic Generalized Gingivitis and Mild Chronic Generalized Periodontitis would be randomly selected from outdoor patients. A minimum 90 Recruited participants will be divided into three equal groups randomly. (Parallel design, case control, Randomized Comparative Study).

Group A: (Test group) (n=30) Ocimum sanctum extract as mouthrinse. Group B: (Positive control group) (n=30) 0.12% Chlorhexidine as mouthrinse. Group C: (control group) (n=30) Vehicle as the mouthrinse. All the three solutions would be prepared under the valuable guidance of Department of Pharmacology, Mahatma Gandhi Memorial Medical College, Indore (M.P.) and will be kept in coded containers. All the participants in each group would be advised to use their respective mouth rinses twice daily with proper swishing action for a minute, after brushing their teeth (in the morning and before going to bed). To maintain standardization, similar toothbrushes and dentifrices will be provided to all the participants (free of cost) and standard tooth brushing techniques will be demonstrated.

Written consent will be obtained from each participants, and then followed by case history taking along with clinical examination by recording various periodontal parameters taken in the study.

Following clinical periodontal parameters are to be recorded at baseline, at 1 week, at 2 weeks, and at 3 weeks:

1. Modified Gingival Index

2. Modified Plaque Index

Sample Size:

Minimum 90 patients with Generalized Chronic Gingivitis or Mild Generalized Chronic Periodontitis will be selected. Participants will be divided into 03 different groups, n=30 participants in each group by computer generated table of random numbers.

Data Collection And Methods:

Cases with Generalized Chronic Gingivitis or Mild Generalized Chronic Periodontitis of either sex and the age group 18-40 years who abide by approved protocol guidelines and are ready to give written informed consent will be selected randomly from OPD (outpatient department) of The Department of Periodontology, Govt. College of Dentistry, Indore (M.P.). The selected participants will be equally divided into three groups, by computer generated random number table.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 31, 2017
• Est. primary completion date: July 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Related Conditions & MeSH terms

• Gingival Diseases
• Gingivitis
• Periodontal Diseases
• Periodontitis

Intervention

Other:
• Ocimum sanctum
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.
• Chlorhexidine Gluconate
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.
• Propylene Glycol
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.

Locations

Country	Name	City	State
India	GCD Indore	Indore	Madhya Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Government College of Dentistry, Indore

Country where clinical trial is conducted

India, 

References & 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. — View Citation

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. — View Citation

Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Minimum Inhibitory Concentration (MIC)	Minimum inhibitory concentration (MIC) is the lowest concentration of a chemical which prevents visible growth of a bacterium. Tested against following periopathogens: Porphyromona sgingivalis, Prevotella intermedia, fusobacteriumnucleatum, Aggregatibacter actinomycetemcomitans, Capnocytophaga, Tanerella forsythia, Pseudomonas aeruginosa, Streptococcus mutans, E. fecalis, and Candida.	Up to 24 hours
Other	Minimum bactericidal concentration (MBC)	Minimum bactericidal concentration (MBC) is the concentration resulting in microbial death as defined by the inability to re-culture bacteria. Tested against following periopathogens: Porphyromona sgingivalis, Prevotella intermedia, fusobacteriumnucleatum, Aggregatibacter actinomycetemcomitans, Capnocytophaga, Tanerella forsythia, Pseudomonas aeruginosa, Streptococcus mutans, E. fecalis, and Candida.	Up to 24 hours
Primary	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	Modified Plaque Index	Plaque Index (Turesky, Gilmore, Glickman modification of Quigely Hein Index, 1970) Scoring was as follows: 0 - No plaque/debris. 1 - Separate flecks of plaque at the cervical margin of the tooth. 2 - A thin continuous band of plaque (up to 1mm) at the cervical margin of the tooth. 3 - A band of plaque wider than 1 mm but covering less than one third of the crown of the tooth. 4 - plaque covering at least one third but less than two thirds of the crown of the tooth. 5 - Plaque covering two third or more of the crown of the tooth. Plaque Index = Total score / no. of surfaces examined	Change from baseline Plaque index at 03 weeks