Comparative evaluation of antibacterial efficacy, Clinical effects and Patient perception on usage of Cetyl pyridinium chloride based products with regular mouthwash and dentifrice in Orthodontic patients- A Randomized control study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 1. anti bacterial efficacy of mouthwash and dentifrice,
Study Overview
Brief Summary
The aim of the academic research study is to compare and assess anti-bacterial efficacy, clinical effects and patient perception using CPC based products with regular mouth wash and dentifrice. 48 Patients who meets inclusion criteria will be included in the study. After the oral prophylaxis, brackets placement followed by arch wire in the baseline will be done. Proper brushing technique is explained to the patients. Based on lottery method patients will be randomly divided into experimental and control groups. Patient will be recalled after 15days. Patients will be prescribed with specific mouthwash/dentifrice and are advised to use them for 1month. Frequency, duration, techniques for use are explained. Clinical parameters such as gingival index and plaque index will be noted for clinical evaluation, Plaque sample will be collected for bacterial evaluation. Patient will be recalled on 30thday and 45th day where gingival index, plaque index will be recorded, plaque sample will be taken for bacterial count, a questionnaire form will be given to the patient to evaluate his perception on usage of these products.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 25.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Age range of 18-25 years.
- •2.Willingness to participate in the study 3.Mild gingivitis 4.Patients with Pre adjusted edgewise stainless steel brackets.
Exclusion Criteria
- •Antibiotic therapy in last month .
- •Medical problems .
- •Pregnancy and lactation .
- •Moderate or severe gingivitis/ periodontitis .
- •Using any mouth rinse in last month.
Outcomes
Primary Outcomes
1. anti bacterial efficacy of mouthwash and dentifrice,
Time Frame: 1. anti bacterial efficacy of mouthwash and dentifrice T0-15thday, T1-30th day, T2- 45thday | 2. Periodontal index T0-15thday, T1-30th day, T2- 45thday | 3. Gingival index T0-15thday, T1-30th day, T2- 45thday
2. Periodontal index
Time Frame: 1. anti bacterial efficacy of mouthwash and dentifrice T0-15thday, T1-30th day, T2- 45thday | 2. Periodontal index T0-15thday, T1-30th day, T2- 45thday | 3. Gingival index T0-15thday, T1-30th day, T2- 45thday
3. Gingival index
Time Frame: 1. anti bacterial efficacy of mouthwash and dentifrice T0-15thday, T1-30th day, T2- 45thday | 2. Periodontal index T0-15thday, T1-30th day, T2- 45thday | 3. Gingival index T0-15thday, T1-30th day, T2- 45thday
Secondary Outcomes
- patients perception by a questionnaire(T1-30th day, T2-45th day)
