Assessing the effect of chlorhexidine-based oral hygiene regimen on nitric oxide oral bioavailability and blood pressure in children aged 12-15 years undergoing orthodontic treatment: a 12-month follow-up study.

Overview:

This study will evaluate the long-term effects of a chlorhexidine-based oral hygiene regimen on salivary NO levels and blood pressure in orthodontic patients over 12 months in children aged 12-15 years. By assessing changes in nitric oxide bioavailability and blood pressure at regular intervals, this study will provide insights into potential systemic implications of prolonged antibacterial mouthwash use in this population.

Aim:

To evaluate the long-term effects of a chlorhexidine-based oral hygiene regimen on nitric oxide bioavailability and blood pressure in adolescents undergoing orthodontic treatment.

Objectives:

1.     To assess the impact of prolonged chlorhexidine mouthwash use on salivary nitric oxide levels over 12 months.

2.     To monitor changes in systolic and diastolic blood pressure in adolescents using chlorhexidine mouthwash as part of their oral hygiene routine.

3.     To compare nitric oxide bioavailability between orthodontic patients using chlorhexidine mouthwash and those using placebo mouthwash.

4.     To evaluate potential correlations between reduced salivary nitric oxide levels and variations in blood pressure.

5.     To analyse whether alterations in oral microbial composition due to chlorhexidine use contribute to changes in nitric oxide metabolism and systemic vascular responses.

6.     To provide clinical recommendations regarding the long-term safety of chlorhexidine-based mouthwashes in orthodontic patients.

Methodology:

A. Materials/Equipment for the Study

1. Oral Hygiene Products:

0.12% Chlorhexidine gluconate mouthwash (Peridex) for the test group.

Placebo mouthwash for the control group.

2. Blood Pressure Measurement Equipment:

Mercury sphygmomanometer (Korotkoff auscultatory method) to measure systolic and diastolic blood pressure.

Standardized BP cuff and stethoscope for repeated measures.

3. BMI measurement Equipment:

Metal Tape measure to record height to the nearest 1/8th inch or 0.1 centimeter.

Digital body weighing scale to record weight to the nearest decimal fraction.

4. Salivary Nitric Oxide Assessment:

Saliva nitric oxide test strips to monitor NO levels as per manufacturer instructions.

B. Sample description

Participants will be categorized into two groups:

1. Test Group: Adolescents using 0.12% chlorhexidine gluconate mouthwash (Peridex) twice daily as part of their oral hygiene routine.
2. Control Group: Adolescents using Placebo mouthwash without chlorhexidine.

Both groups will be assessed for changes in salivary nitric oxide levels and blood pressure over the study period.

C. Time Scale of Study

The study will be conducted over a total period of 12 months.

Phase I: Record clinical readings at weekly intervals over 4 weeks.

Phase II: After a 3-month washout period, resume CHX use and again record weekly

readings for another 4 weeks.

A 3-month washout period would allow us to assess both the short-term and any potential long-term effects without continuous exposure.

At each time point, blood pressure and salivary nitric oxide levels will be measured to track changes over time.