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The goal of this clinical trial is to evaluate and compare the antiplaque efficacy and patient reported outcome of three commonly used antiseptic mouthwashes - Chlorhexidine (CHX), Cetylpyridinium Chloride (CPC), and Essential Oil (EO) formulations - in orthodontic patients undergoing fixed appliance therapy. The main question it aims to answer is:
In orthodontic patients wearing fixed appliances, what is the comparative effect of chlorhexidine, cetylpyridinium chloride, and essential-oil mouthwashes versus placebo on clinical periodontal parameters, salivary IL-1β levels, and patient-reported outcomes.
Prior to enrollment in the clinical trial, all potential participants will undergo a preparatory phase for one month aimed at achieving optimal oral health and minimizing confounding baseline inflammation. During this phase, participants will receive a full professional oral prophylaxis, including scaling and polishing, to remove dental plaque and calculus deposits. This ensures that all individuals begin the study with a comparable level of oral hygiene and gingival health.
Participants will be instructed on a standardized oral hygiene regimen, including proper toothbrushing technique using a soft-bristled toothbrush and fluoridated toothpaste twice daily. In addition, each participant will be provided with a single-tufted brush as an interproximal cleaning aid to maintain plaque control around orthodontic brackets and hard-to-reach areas. The use of any other mouthwash or adjunctive antimicrobial agent will be prohibited during this phase. After preparatory phase, participants will undergo a four-day plaque-accumulation period immediately prior to baseline clinical and biochemical assessments. During this 4-day period participants will be instructed to refrain from all mechanical oral hygiene procedures (no toothbrushing, interdental cleaning, or mouthrinse use) in order to standardize plaque formation across subjects and create a measurable baseline plaque burden for subsequent comparisons.
After that, In base line visit the salivary sample will be collected for IL-1β measurement and clinical periodontal parameters (PI,GI,BOP,PPD) will be measured and receiving oral hygiene instructions and motivation, and first intervention will be given to the patient.
After one week Saliva will be collected for IL-1β measurement and the clinical measurements ( PI,GI,BOP)will be taken, then the participant goes into washout period for two weeks, after that the participant will be called to repeat the same protocol for the remaining three interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorohexidine mouthwash | Experimental | Chlorohexidine 0.12% mouthwash |
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| Cetylpyridinium chloride mouthwash | Experimental | Cetylpyridinium chloride 0.05% mouthwash |
|
| Essential oil mouthwash | Experimental | Essential oil mouthwash |
|
| Placebo mouthwash | Placebo Comparator | Placebo mouthwash |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorohexidine 0.12% mouthwash | Drug | Participants will rinse with 15 mL chlorhexidine gluconate 0.12% mouthwash (Kin Gingival) for 30 seconds twice daily for 7 days. Participants will avoid eating or drinking for 30 minutes after rinsing. This intervention is used as an antimicrobial mouthwash to reduce dental plaque and gingival inflammation. |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque index (PI) | To assess supragingival plaque accumulation around orthodontic brackets before and after each intervention phase, using using Löe and Silness index on four surfaces (mesial, buccal, distal, lingual,). Each surface is normally given a score of 0 to 3 as follows: 0 = no plaque, 1 = a film of plaque adhering to the free gingival margin and adjacent area of the tooth, the plaque may be recognized only by running a probe across the tooth surface, 2 = moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, visible to the naked eye, 3 = abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. | 10 weeks |
| Gingival index (GI) | To evaluate gingival inflammation before and after each intervention phase, using Löe and Silness index, each of the four gingival areas of the tooth is given a score from 0 to 3 as follows: 0 = Normal gingiva, 1 = Mild inflammation slight change in color, slight oedema. No bleeding on probing, 2 = Moderate inflammation-redness, oedema and glazing. Bleeding on probing, 3 = Severe inflammation marked redness and oedema, ulceration, tendency to spontaneous bleeding. | 10 weeks |
| Salivary interleukin-1 beta (IL-1β) levels | Quantified using an enzyme-linked immunosorbent assay (ELISA) to assess inflammatory response before and after each intervention phase. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding on probing (BOP) | Recorded as the percentage of sites with bleeding within 30 seconds of gentle probing, BOP will be measured by gently inserting the periodontal probe to the depth of the gingival sulcus\ periodontal pocket then removed coronally and waited for 30 seconds to observe the presence of bleeding (0 = no bleeding, 1 = presence of bleeding). | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Dentistry, University of Baghdad | Baghdad | Baghdad Governorate | Iraq |
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This study is 4 arms, randomized, triple-blind, crossover clinical trial conducted among orthodontic patients with fixed appliances.
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This is a triple-blind design in which the participants, the examiner, and the analyst/statistician all will be blinded to the identity of the mouthwash.
The supervisor is the only person aware of the mouthwash identity, she will use empty bottles of the same size and shape for the interventions, label them with English letters(A, B, C, D), and distribute them according to a randomized sequence generated using a computer program. The examiner will follow the treatment sequence given for every patient.
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| Cetylpyridinium chloride 0.05% mouthwash | Drug | Participants will rinse with 15 mL alcohol-free cetylpyridinium chloride (CPC) 0.05% mouthwash (Kin B5) for 30 seconds twice daily for 7 days. Participants will avoid eating or drinking for 30 minutes after use. CPC acts as a quaternary ammonium antimicrobial agent that disrupts bacterial membranes. |
|
| Essential Oil mouthwash | Drug | Participants will rinse with 15 mL essential oil mouthwash (Listerine) for 30 seconds twice daily for 7 days. Participants will refrain from eating or drinking for 30 minutes after rinsing. Essential oils act by disrupting bacterial cell walls and inhibiting microbial enzyme activity. |
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| Placebo mouthwash | Other | Participants will rinse with 15 mL flavored distilled water for 30 seconds twice daily for 7 days. The placebo solution has similar appearance and flavor but contains no active antimicrobial ingredients. |
|
| Tolerability (VAS) scale | - Visual analog scale(VAS) scores (0-10) for taste acceptability, burning sensation, and mucosal irritation. ( 0 = no means no pain, 10 = worst possible pain). | 10 weeks |
| Patient satisfaction (Likert scale) | Assessed via a short-structured questionnaire (Likert-scale format) after each intervention period:
| 10 weeks |
| Adverse events | Clinical observation for staining, ulceration, or desquamation.(Yes/NO) | 10 weeks |
| ID | Term |
|---|---|
| D009067 | Mouthwashes |
| D002594 | Cetylpyridinium |
| ID | Term |
|---|---|
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D003358 | Cosmetics |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D011726 | Pyridinium Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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