Comparative evaluation of efficacy of antimicrobial mouthwash and probiotic mouthwash on streptococcus mutans levels in saliva and gingival health of patients undergoing fixed orthodontic treatment. A Randomized Clinical Trial.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dr Gopal Cheke
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- To check if the intervention that is probiotic mouthwash has a beneficial effect for reducing bacterial levels in saliva in the patients undergoing orthodontic treatment.
Overview
Brief Summary
A randomized clinical trial will be conducted on 54 patients undergoing fixed orthodontic treatment. Patients are divided into 3 groups having 18 patients in each group. The groups will be as follows:
Group 1- Antimicrobial mouthwash group.
Patients in this group will be given 0.2% antimicrobial mouthwash and will be advised to use it twice daily. Patient will be educated about how to use the
mouthwash. Instructions to maintain proper oral hygiene will be given.
Group 2- Probiotic mouthwash.
Patients in this group will be given probiotic mouthwash. They will be advised to use it twice daily. Patient will be educated about how to use the mouthwash. Instructions to maintain proper oral hygiene will be given.
Group 3- Control group
Patients in this group are used as control group. They will be advised to brush twice daily with toothpaste and instructions to maintain proper oral hygiene will be given.
The saliva samples of the patients will be collected in the sterile containers. The samples will be collected at two intervals that is at 1st day and 30th day. The collected samples will be store in deep freezer at -20 degree Celsius. The collected saliva samples will be then transported to the laboratory for PCR analysis.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 14.00 Year(s) to 28.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient undergoing orthodontic treatment with preadjusted edgewise appliance (MBT).
- •Overall good general health.
- •Permanent dentition.
- •No anti-inflammatory or antibiotics and mouthwash used in last week.
Exclusion Criteria
- •Patient with facial deformities.
- •Patient with severe periodontal problems.
- •History of parafunctional habits.
- •History of maxillofacial surgery or jaw injuries.
Outcomes
Primary Outcomes
To check if the intervention that is probiotic mouthwash has a beneficial effect for reducing bacterial levels in saliva in the patients undergoing orthodontic treatment.
Time Frame: 1 day, 30 days.
Secondary Outcomes
- To check if the control group shows similar effects as that of the intervention group or less than that.(1 day, 30 days.)
Investigators
Gopal Cheke
Saraswati dhanwantari dental college, pathari road parbhani.