A comparative evaluation of the effect of two types of mouthwashes on the bacterial flora and health of the oral cavity

Completed

• Conditions: Other specified diseases of hard tissues of teeth,; Patients requiring fixed orthodontic treatment for the correction of malocclusion

• Registration Number: CTRI/2021/07/034736
• Lead Sponsor: Dr Shrestha Bisht

Brief Summary

Fixed orthodontic therapy increases plaque retention areas and jeopardizes oral hygiene maintenance and hence is a risk factor for plaque accumulation. The complex design of orthodontic bands and brackets may create an ecological environment that facilitates the establishment and growth of cariogenic bacteria. Design and surface characteristics of both orthodontic attachment and roughness of the composite influence plaque retention. This undisturbed plaque induces gingivitis, gingival hyperplasia, and periodontitis which itself might interfere with orthodontic outcome by detachment of connective tissue and inhibition of remodelling and also leads to the development of dental caries and white spot lesions due to enamel demineralization. Although mechanical removal of dental biofilm is still considered the main method, routine brushing protocols might not suffice to reduce the increased plaque accumulation in orthodontic patients. A recent literature review suggested that improved antimicrobial solutions are urgently needed to prevent biofilm-related complications of orthodontic treatment. The use of mouth rinses has been introduced as an effective way of reducing dental plaque accumulation. Orthodontic patients are prescribed various chemical agents such as chlorhexidine, Listerine, etc. Among frequently used antiseptic mouthwashes, Chlorhexidine (CHX) is known as the most potent chemical agent. However, CHX has side effects like discolouration of the teeth, irritation of oral mucosal, and an unpleasant taste. Therefore, the search for other antimicrobial substances with fewer side effects continues. One such novel mouth rinses is mouthwash containing Silver Nanoparticles (SNP). Silver and its derivatives are the oldest antimicrobial agent in traditional medicine. SNP are stable in solutions and their antimicrobial properties can remain for a long time. SNP release silver ions with a positive charge. These ions may cling to DNA and proteins, because these molecules contain compounds with a negative charge, such as phosphorus and sulphur. Furthermore, Ag ions may cling to the surface of the microorganisms causing disruption in the integrity of the cell wall, and hence are bactericidal. SNPs present a greater surface-to-volume ratio (per unit mass), interacting more closely with microbial membranes and provide a considerably larger surface area for antimicrobial activity. A commercially available mouthwash containing SNP is NanOlife (Dhanvantri Nano Ayushodi Pvt. Ltd.) The mouthwash is alcohol-free and contains Ag- 100% NP prepared by innovative Green Nanotechnology. Although the benefits of using SNP mouthwash is present in literature, not many clinical studies are done to prove its efficacy in the oral environment. Hence,the aim of this study is to compare the effect of Silver Nanoparticles containing (NanOlife) mouthwash with CHX on the colonization of microorganisms on the fixed orthodontic elastomeric modules and on the gingival health of the patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-19
• Study Completion: 2021-11-30
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 1.Subjects’ willingness to participate.
• 2.The indication for fixed orthodontic treatment, between 15-30years of age.
• 3.Lack of dental caries and/or restorations.
• 4.Absence of severe dental plaque (plaque index ≤ 20% measured by O’Leary index using plaque disclosing agent) / severe gingival inflammation/severe periodontal condition.
• 5.Absence of any systemic diseases.
• 6.Not having used any mouth rinses for at least 1 month before the initiation of the study.
• 7.Not on antibiotics and/or anti inflammatory drugs in the past 3 months.

Exclusion Criteria

• 1.History of previous periodontal treatments.
• 2.Active periodontal diseases.
• 3.Mouth breathing or any other problems which could affect oral microbial flora.
• 4.Presence of dental crowding(>4mm).
• 5.Sign of sensitivity to mouthwashes during the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effectiveness of silver nanoparticle mouthwash and Chlorhexidine mouthwash on gingival health and count of microorganisms during fixed orthodontic treatment.	3 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of silver nanoparticle mouthwash on gingival health and colonization of microorganisms during fixed orthodontic treatment.

Trial Locations

Locations (1)

Subharti Dental College and Hospital; 🇮🇳 Meerut, UTTAR PRADESH, India

Subharti Dental College and Hospital

🇮🇳Meerut, UTTAR PRADESH, India

Dr Shrestha Bisht

Principal investigator

09568301324

drshresthabisht@gmail.com