Effect of Moringa Oleifera Mouthwash

Study Overview
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Brief Summary
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Improvement of oral hygiene maintenance is very important during fixed orthodontic appliance treatment to prevent the degenerative effects. Different mouthwashes are available in market but this study is being conducted to check the effects of Moring Oleifera mouth wash against the development of Gingivitis, Periodontitis, Plaque formation, Enamel Demineralization /white spot lesion, discoloration and bacterial load in dental plaque during the fixed orthodontic treatment.

Detailed Description
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With the increase in desire of improved facial and dental aesthetics among all social classes, the numbers of cases being treated with fixed orthodontic appliances are increasing. It is difficult to maintain certain standard of oral hygiene with the braces on, so the iatrogenic degenerative effects of fixed orthodontic appliances are somewhat inevitable. Along with proper brushing and flossing orthodontists advise the use of mouthwash as well in order to prevent or lessen the severity of gingivitis, periodontitis, gingival hyperplasia, demineralization, white spot lesions, discoloration of teeth etc. Plenty of mouth washes are available in market containing varying concentration of different chemicals promising to improve the oral health and reduce inflammation. But all of them having certain side effects most common being the discoloration. The focus is being shifted to natural ingredients to gain the same or even better results with minimum to zero side effects. In quest of getting closer to Mother Nature Moringa Oleifera leaf was discovered in 1785 in Indian Subcontinent. Moringa Oleifera is a nutraceutical and well known for its anti-inflammatory, anti-microbial, anti-cancer, anti-diabetes, anti-rheumatoid arthritis, hepatoprotective, Steroid-genesis modulators and neuroprotective functions and many other properties. Its leaves evidently contain various natural anti-inflammatory and anti-oxidant substances namely flavonoid, phenolic and carotenoid. Besides, MO leaves also rich in protein, vitamin C, vitamin A, calcium and potassium. Flavonoids may act as antioxidant by scavenging free radical and protecting the cell from oxidative stress. Recently quite a lot work has been done on flavonoids in dentistry which includes anti-bacterial/anti-cariogenic effects, reduction in plague formation, Treatment in surgical wounds, reduction in dentinal hypersensitivity, treatment of periodontitis and gingivitis because of its anti-inflammatory and anti-oxidative effects. Previously studies have been done to check the efficacy of different herbal mouthwashes but no study has been done to check the efficacy of MO leaf extract mouth wash on the oral health of the patients having fixed orthodontic treatment

Official Title
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Effects of Moringa Oleifera Mouthwash in Patients Undergoing Fixed Orthodontic Appliance Treatment: a Parallel Arm, Triple Blinded, Randomized Controlled Trial

Conditions
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Orthodontic Appliance Complication

Intervention / Treatment
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* Other: Moringa Oleifera Mouthwash
* Other: Placebo Mouthwash


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Young healthy subjects undergoing orthodontic treatment. Patients with all permanent teeth present without any oral pathology. Healthy gingiva with no bleeding on probing before start of orthodontic treatment and a normal pocket depth (1-3mm) on all teeth. No WSLs (score = 1 Exclusion Criteria: History of smoking, patients suffering from any systemic illness like diabetes. Gingivitis or an active periodontal disease. Carious lesions on labial/buccal surface of teeth. Mentally handicapped individuals

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moringa Oleifera Mouthwash<br>15ml of Moringa Oleifera mouthwash will be given to be used twice daily for 6 months. | Other: Moringa Oleifera Mouthwash<br>* 15ml of the mouthwash to be used twice daily for 6 months<br>|
| Placebo Comparator: Placebo Mouthwash<br>The mouthwash will have all other ingredients other than Moringa Oleifera extract. Participants will be advised to use 15ml of Placebo mouthwash twice daily for 6 months. | Other: Placebo Mouthwash<br>* 15ml of the mouthwash to be used twice daily for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal Probing Depth | Changes from baseline, the probing depth scale will be used to assess the pocket depth, and is graded from 0-5, 0= no No pockets>3.5mm, no calculus/overhangs, no bleeding after probing(black band completely visible). 1=No pockets>3.5mm, no calculus/overhangs, but bleeding after probing(black band completely visible). 2= No pockets>3.5mm, but supra or subgingival calculus/overhangs(black band completely visible). 3=Probing depth 3.5-5.5mm (black band partially visible, indicating pocket of 4-5mm). 4=Probing depth> 5.5mm (black band entirely within pocket, indicating pocket of 6mm or more). 5=Furcation involvement. | 7 months | 
| Plaque Index | Changes from base line, quantity of plaque will be assessed using plaque index, graded from 0-4, 0=Absence of microbial plaque. 1=Thin film of microbial plaque along the free gingival margin. 2=Moderate accumulation with plaque in the sulcus. 3=Large amount of plaque in sulcus or pocket along the free gingival margin. | 7 months | 
| White spot Lesions | Changes from the baseline, white spot lesions will be assessed visually by grading from 1-4. 1= Normal, 2= Slight, 3= Severe, 4= Cavitation. | 7 months | 
| Modified Gingival Index | Changes from the baseline, gingivitis will be assessed using this index graded from0-4, 0= Normal, 1=Mild inflammation, slight change in color, little change in texture of any portion of gingival unit. 2= Mild inflammation of entire gingival unit. 3=Moderate inflammation of entire gingival unit. 4=Severe inflammation of entire gingival unit. | 7 months | 
| Discoloration of teeth | Changes from the baseline, discoloration will be assessed by taking photographs on every interval using the same camera at the same settings. these photographs will be assessed from by 2 panels 2 weeks apart. | 7 months | 
| Bacterial Load In Plaque | Changes from the baseline, Colony forming units will be measured by doing microbial analysis. Quantity of CFUs for S. mutans and P. Gingivalis will be used. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moringa Oleifera, Moringa Mouthwash, Fixed Orthodontic Treatmnet, Moringa Mouthwash in orthodontics, Orthodontics