Effect of Moringa Oleifera Mouthwash

NCT05191069 | Unknown

• 1 other identifier: MINS/69/2020 Rabia Afreen
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthodontic Appliance Complication

Keywords

Moringa Oleifera; Moringa Mouthwash; Fixed Orthodontic Treatmnet; Moringa Mouthwash in orthodontics; Orthodontics

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Moringa Oleifera Mouthwash

EXPERIMENTAL

15ml of Moringa Oleifera mouthwash will be given to be used twice daily for 6 months.

Other: Moringa Oleifera Mouthwash

Placebo Mouthwash

PLACEBO COMPARATOR

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

Interventions

Moringa Oleifera Mouthwash OTHER

15ml of the mouthwash to be used twice daily for 6 months

Moringa Oleifera Mouthwash

Placebo Mouthwash OTHER

15ml of the mouthwash to be used twice daily for 6 months

Placebo Mouthwash

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Islamic International Dental Hospital

Islamabad, Islamabad, 44000, Pakistan

Location

Related 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.

  PMID: 22044115 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25055220 BACKGROUND

• 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.

  PMID: 33215489 BACKGROUND

• 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.

  PMID: 22957711 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25210379 BACKGROUND

• 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.

  PMID: 28620474 BACKGROUND

• 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.

  PMID: 34204096 BACKGROUND

• 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.

  PMID: 5237684 BACKGROUND

Study Officials

• Ulfat Bashir, Masters

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 13, 2022
• Study Start: December 23, 2021
• Primary Completion: September 30, 2022
• Study Completion: October 30, 2022
• Last Updated: January 13, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)