The aim of this investigation is to determine the efficacy of coconut oil and moringa oleifera as antimicrobials in the oral cavity in comparison to chlorhexidine.
The participants will be recruited at the dental clinics at Riphah International University over a period of 4 weeks. Each participant will be required to sign a consent form before proceeding with the trial.
Participants/Inclusion and exclusion criteria
Individuals who maintain good oral health will be enrolled in the study. Those with periodontal disease, systemic illnesses or medications that affect periodontal health will be excluded. People with recent history of oral prophylaxis or antibiotic use will also be excluded.
Intervention groups
The participants will be divided into 3 different groups, coconut oil (C), moringa oleifera (M) and chlorhexidine (Control). Each participant will be given a unique number. All 3 groups; with 30 participants each, will be sampled for plaque and gingival crevicular fluid from the lingual surface of lower incisors. The collected sample will be placed will be transported to the laboratory for detailed microbiologic analysis. Each group will be given a specially formulated mouthwash according to their allocation. These participants will be instructed to rinse will 15 mL mouthwash twice daily for 14 days. Reminder text messages will be sent twice daily to ensure compliance. Each participant will be sampled again following completion of 2 weeks. The pre-mouthwash microbial results will be compared with the post-mouthwash samples.
Main outcome variables
The difference of the pre-mouthwash and post-mouthwash oral microbial species will be compared.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210212050332N1
Registration date:2021-02-16, 1399/11/28
Registration timing:prospective
Last update:2021-02-16, 1399/11/28
Update count:0
Registration date
2021-02-16, 1399/11/28
Registrant information
Name
Amber Kiyani
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 51 2891835
Email address
akiyani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of antimicrobial properties of coconut oil, moringa oleifera and chlorhexidine on oral bacterial populations
Public title
Effect on coconut oil, moringaoleifera and chlorhexidine on oral health.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Good oral hygiene.
Good brushing habits.
Exclusion criteria:
Periodontal disease.
Systemic disease affecting periodontal health.
Recent history of oral prophylaxis.
Recent history of antibiotic use.
Age
From 18 years old to 40 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Committee, Riphah International University
Street address
Riphah International University, Islamic International Dental College, 7th Avenue, G-7/4
City
Islamabad
Postal code
44000
Approval date
2017-10-06, 1396/07/14
Ethics committee reference number
IIDC/IRC/2017/10/006
Health conditions studied
1
Description of health condition studied
Caries
ICD-10 code
K02.9
ICD-10 code description
Dental caries, unspecified
2
Description of health condition studied
Periodontitis
ICD-10 code
K05.6
ICD-10 code description
Periodontal disease, unspecified
Primary outcomes
1
Description
Oral microbial populations
Timepoint
2 weeks
Method of measurement
Culture, PCR, biochemical methods
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: (Coconut oil). 30 individuals in this group will be sampled from the sub gingival area of the lingual surfaces of lower central incisors. The plaque and gingival crevicular fluid collected will be sent for detailed microbiologic analysis (PCR, biochemical testing, bacterial culture). All individuals will be given an emulsion of non-hydrogenated coconut oil as a mouthwash. The participant will be requested to rinse with 15 mL emulsion twice daily. On day 14, the participant will be undergo microbiologic analysis again from the same site.
Category
Treatment - Drugs
2
Description
Intervention group: (Moringa Oleifera). 30 individuals in this group will be sampled from the sub gingival area of the lingual surfaces of lower central incisors. The plaque and gingival crevicular fluid collected will be sent for detailed microbiologic analysis (PCR, biochemical testing, bacterial culture). All individuals will be given a mouthwash made with moringa oleifera extract. The participant will be requested to rinse with 15 mL solution twice daily. On day 14, the participant will be undergo microbiologic analysis again from the same site.
Category
Treatment - Drugs
3
Description
Control group: (Chlorhexidine gluconate). Chlorhexidine gluconate is a gold standard antibacterial for the oral cavity. This is why it will be used in the control group to compare the efficacy of gold standard against the coconut oil and moringa oleifera mouthwashes. 30 individuals in this group will be sampled from the sub gingival area of the lingual surfaces of lower central incisors. The plaque and gingival crevicular fluid collected will be sent for detailed microbiologic analysis (PCR, biochemical testing, bacterial culture). All individuals will be given a 0.2% chlorhexidine. The participant will be requested to rinse with 15 mL solution twice daily. On day 14, the participant will be undergo microbiologic analysis again from the same site.