Effect of Moringa Oleifera Mouthwash

Orthodontic Appliance Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05191069
• Other study ID #: MINS/69/2020 Rabia Afreen
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 23, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: December 2021
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: October 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Orthodontic Appliance Complication

Intervention

Other:
• Moringa Oleifera Mouthwash
15ml of the mouthwash to be used twice daily for 6 months
• Placebo Mouthwash
15ml of the mouthwash to be used twice daily for 6 months

Locations

Country	Name	City	State
Pakistan	Islamic International Dental Hospital	Islamabad	Islamabad Capital Territory

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (11)

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. Review. — View 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

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). pii: 1153. doi: 10.3390/plants10061153. — View 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

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. Epub 2014 Jul 11. — View 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(1):981-990. doi: 10.3290/j.ohpd.a45437. — View Citation

Löe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. — View 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. Review. — View 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. Review. — View 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

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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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