Comparative study of topical effects of Probiotics with a commercial fluoride tooth paste in reducing dental caries in patients with higher salivary Streptococcus mutans levels.
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Outcome is measured by decrease in Streptococcus colony forming units / ml of saliva
Study Overview
Brief Summary
Study is a prospective clinical trial to analyse the anticaries effect of probiotic tooth paste and compare it with regularly prescibed fluoride tooth paste. Outcome is assessed by decrease in Salivary streptococcus mutans CFU/ml, change in salivary flow rate (both stimulated and unstimulated), change in salivary and plaque pH. Theoretically Probiotic lactobacillus strain competitively inhibits colonization of streptococcus mutans in plaque and ultimately reduced dental caries. This concept is applied in my study. Probiotic tooth paste preparation is given for sample size of 20 randomly selected and it is brushed for 15 days after which outcome is measured. Another group of 20 patients are given fluoride tooth paste and it is brushed for 15 days and outcome measured. Both groups are compared. If the study proves to be statistically significant it will be a boon to dentistry.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 15.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •patients with Streptococcus mutans CFU/ml above 5 million/ml of saliva and DMF index above 5.
Exclusion Criteria
- •patients with Streptococcus mutans CFU/ml below 5 million/ml of saliva and DMF index below 5 and edentulous patients.
Outcomes
Primary Outcomes
Outcome is measured by decrease in Streptococcus colony forming units / ml of saliva
Time Frame: After 15 days usage of tooth paste.
Secondary Outcomes
- Increase in salivary flow rate, increase in salivary pH, increase in plaque pH. No risk of mortality.(15 days after tooth paste usage.)