Dental Plaque, Gingivitis
Conditions
Keywords
Listerine, Chlorhexidine, Gingival Index, Plaque Index, Oral Hygiene, Orthodontic Appliances
Brief summary
This randomized clinical trial aims to compare the effectiveness of Listerine and Chlorhexidine mouthwashes in improving periodontal health in patients undergoing fixed orthodontic treatment. Gingival Index and Plaque Index will be assessed at baseline, 2 weeks, and 4 weeks.
Detailed description
Orthodontic treatment using fixed appliances can significantly impair oral hygiene due to the presence of brackets, bands, and wires, which create retentive areas that promote plaque accumulation. This buildup can result in gingival inflammation, leading to gingivitis or even periodontitis if not managed effectively. Mechanical plaque control, such as brushing and flossing, is often insufficient under these conditions. Thus, adjunctive chemical plaque control agents like mouthwashes are commonly recommended. Chlorhexidine (CHX) is widely considered the gold standard for chemical plaque control due to its broad-spectrum antimicrobial activity and prolonged substantivity in the oral cavity. However, CHX is associated with side effects such as tooth staining, altered taste sensation, and mucosal irritation, limiting its long-term use. In contrast, Listerine is a commercially available essential oil-based mouthwash that has demonstrated anti-plaque and anti-inflammatory properties without the same level of side effects. This double-blind, randomized controlled trial aims to compare the clinical efficacy of CHX (0.12%) and Listerine mouthwash in improving periodontal health among patients undergoing fixed orthodontic treatment. The study will be conducted over a period of 4 weeks at the Orthodontics Department of Saidu College of Dentistry, Swat. A total of 60 participants (30 per group), aged between 13 and 25 years, will be enrolled using non-probability consecutive sampling. Participants will be randomized into two groups using block randomization: one receiving CHX and the other Listerine, both in identical, unlabelled bottles to ensure blinding of both the investigator and participants. The primary outcome measures are changes in Plaque Index (PI) and Gingival Index (GI), assessed at baseline (Day 0), 2 weeks, and 4 weeks. Oral examinations will be conducted by calibrated examiners using standard indices and WHO probes. Data will be analyzed using R software, with t-tests applied to compare mean scores between groups. Age and gender will be considered as potential effect modifiers. The study is designed to evaluate whether Listerine, as a more tolerable alternative, provides comparable or superior improvements in periodontal health compared to CHX in orthodontic patients. If proven effective, Listerine may serve as a safer, more acceptable option for long-term use during orthodontic treatment.
Interventions
DRUGListerine Mouthwash Product
Participants in this group will receive Listerine mouthwash containing essential oils (menthol, thymol, eucalyptol, and methyl salicylate). They will be instructed to rinse once daily with 10 ml of the solution for 30 seconds after brushing, over a period of 4 weeks. The mouthwash will be dispensed in unlabelled bottles to maintain blinding. Standard oral hygiene instructions will be given.
DRUGChlorhexidine mouthwash
Participants in this group will receive Chlorhexidine mouthwash at a concentration of 0.12%. They will be instructed to rinse once daily with 10 ml of the solution for 30 seconds after brushing, over a period of 4 weeks. The mouthwash will be dispensed in unlabelled bottles to maintain blinding. Standard oral hygiene instructions will be given.
Sponsors
Khyber Medical University Peshawar
Saidu College of Dentistry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Participants will be randomly assigned to either the Chlorhexidine or Listerine group using a block randomization method. To ensure blinding, both mouthwashes will be dispensed in identical, unlabelled bottles. Neither the participants, the care providers will be aware of the group allocation throughout the study period.
Intervention model description
A two-arm, parallel group design where participants are randomly assigned to receive either Chlorhexidine or Listerine mouthwash for 4 weeks. Each participant remains in their assigned intervention group throughout the study without crossover.
Eligibility
Sex/Gender
ALL
Age
13 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 13-40 years * Permanent dentition (including first molars) * Willing to undergo orthodontic treatment and follow instructions
Exclusion criteria
* Systemic illness (e.g., diabetes, heart disease, hepatitis) * Pregnant/lactating females * Tobacco use * History of allergies to mouthwash/toothpaste * Use of mouthwash in past 3 months * Abnormal oral morphology or parafunctional habits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Index (GI) | baseline, 2 weeks, and 4 weeks , 8 week | Measured using standard GI scale (Grades 0-3) |
| Plaque Index (PI) | baseline, 2 weeks, and 4 weeks , 8 week | Measured using Orthodontic Plaque Index (Grades 0-4) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects | Baseline till 8 weeks | The side effects of the trial will be noted in the adverse event log frame. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORFazli Rabi, MPH*
Khyber Medical University
PRINCIPAL_INVESTIGATORDr Naveed Sadiq, PhD
Khyber Medical University
Outcome results
None listed