Clinical trial NCT05191069: Effect of Moringa Oleifera Mouthwash
Official title: Effects of Moringa Oleifera Mouthwash in Patients Undergoing Fixed Orthodontic Appliance Treatment: a Parallel Arm, Triple Blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic Appliance Complication
Keywords: Moringa Oleifera
Moringa Mouthwash
Fixed Orthodontic Treatmnet
Moringa Mouthwash in orthodontics
Orthodontics
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 50
Sex: ALL
Minimum age (years): 13
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Periodontal Probing Depth
timeFrame: 7 months
measure: Plaque Index
timeFrame: 7 months
measure: White spot Lesions
timeFrame: 7 months
measure: Modified Gingival Index
timeFrame: 7 months
measure: Discoloration of teeth
timeFrame: 7 months
measure: Bacterial Load In Plaque
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Islamic International Dental Hospital
state: Islamabad Capital Territory
Study officials:
affiliation: Riphah International University
name: Ulfat Bashir, Masters
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Anezi SA, Harradine NW. Quantifying plaque during orthodontic treatment: Angle Orthod. 2012 Jul;82(4):748-53. doi: 10.2319/050111-312.1. Epub 2011 Nov 1.
citation: Atanasova S, Kovachevska I, Nashkova S, Toneva V, Zlatanovska K, Longurova N. Side effects of orthodontic treatment. Knowledge International Journal. 2018;23(2):665-71
citation: Sioustis I, Martu M-A, Luchian I, Teodorescu C, Kappenberg-Nitescu D-C, Iovan A, et al. Clinical effects of orthodontic treatment on periodontal status. Review. Rom J of Medical and Dental Education. 2019;8(3):57-6
citation: Haas AN, Pannuti CM, Andrade AK, Escobar EC, Almeida ER, Costa FO, Cortelli JR, Cortelli SC, Rode SD, Pedrazzi V, Oppermann RV. Mouthwashes for the control of supragingival biofilm and gingivitis in orthodontic patients: evidence-based recommendations for clinicians. Braz Oral Res. 2014 Jul 11;28(spe):1-8. doi: 10.1590/1807-3107bor-2014.vol28.0021. Epub 2014 Jul 11.
citation: Jeyakumar J, Sculean A, Eick S. Anti-biofilm Activity of Oral Health-care Products Containing Chlorhexidine Digluconate and Citrox. Oral Health Prev Dent. 2020 Oct 27;18(4):981-990. doi: 10.3290/j.ohpd.a45437.
citation: Van Strydonck DA, Slot DE, Van der Velden U, Van der Weijden F. Effect of a chlorhexidine mouthrinse on plaque, gingival inflammation and staining in gingivitis patients: a systematic review. J Clin Periodontol. 2012 Nov;39(11):1042-55. doi: 10.1111/j.1600-051X.2012.01883.x. Epub 2012 Sep 7.
citation: Dubey DK, Dora J, Kumar A, Gulsan RK. A multipurpose tree-Moringa oleifera. International Journal of Pharmaceutical and Chemical Sciences. 2013;2(1):415-23
citation: Sankari SL, Babu NA, Rani V, Priyadharsini C, Masthan KM. Flavonoids - Clinical effects and applications in dentistry: A review. J Pharm Bioallied Sci. 2014 Jul;6(Suppl 1):S26-9. doi: 10.4103/0975-7406.137256.
citation: Panche AN, Diwan AD, Chandra SR. Flavonoids: an overview. J Nutr Sci. 2016 Dec 29;5:e47. doi: 10.1017/jns.2016.41. eCollection 2016.
citation: Buakaew W, Sranujit RP, Noysang C, Sangouam S, Suphrom N, Thongsri Y, Potup P, Usuwanthim K. Evaluation of Mouthwash Containing Citrus hystrix DC., Moringa oleifera Lam. and Azadirachta indica A. Juss. Leaf Extracts on Dental Plaque and Gingivitis. Plants (Basel). 2021 Jun 6;10(6):1153. doi: 10.3390/plants10061153.
citation: Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.