Clinical trial NCT03474146: Comparative Evaluation of Antiplaque and Antigingivitis Efficacy of Ocimum Sanctum (Tulsi) Extract
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."
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Gingivitis
Periodontitis
Keywords: Mouthrinse
Ocimum sanctum
Periodontal Diseases
Tulsi
Lead sponsor: Government College of Dentistry, Indore
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Modified Gingival Index
timeFrame: Change from baseline Gingival index at 03 weeks
Secondary outcomes:
measure: Modified Plaque Index
timeFrame: Change from baseline Plaque index at 03 weeks
Other outcomes:
measure: Minimum Inhibitory Concentration (MIC)
timeFrame: Up to 24 hours
measure: Minimum bactericidal concentration (MBC)
timeFrame: Up to 24 hours
Locations:
city: Indore
country: India
facility: GCD Indore
state: Madhya Pradesh
Study officials:
affiliation: Govt. College of Dentistry, Indore, Madhya pradesh, India
name: Dr. Subhash Garg, M.D.S.
role: STUDY_DIRECTOR
References:
citation: 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.
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. No abstract available.
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. doi: 10.1902/jop.1970.41.41.41. No abstract available.