Remineralization Efficacy of Moringa Oleifera Varnish Vs MI Varnish in Initial Carious Lesions Over 6 Months Follow Up: a Randomized Controlled Clinical Trial

NCT06905379 | Not Yet Recruiting DMC

• 1 other identifier: Moringa Oleifera-based varnish
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial aimed to test the remineralization effect of laboratory prepared Moringa Oleifera based varnish compared to MI varnish (CPP-ACP) on incipient carious lesions. The study could include any of the following participants: age: 25-35 years, males or females, presentation with at least one active WSLs on the study teeth at the start of the study, good oral hygiene, co-operative patients approving to participate in the trial, have sufficient cognitive ability to understand consent procedures. The main question it aims to answer is in patients with initial caries lesions will Moringa Oleifera varnish have same remineralization efficacy as MI Varnish after 6 months follow up? MI varnish will be used as a comparator as it has been shown in many studies to be superior to fluoride varnish with NaF alone in arresting early caries lesions. The active ingredient, CPP-ACP can slowly release, localize and stabilize amorphous calcium, phosphate, and fluoride on the enamel surface which aids in deep mineralization of white spot lesions.

Conditions

White Spot Lesions [Initial Caries] on Smooth Surface of Tooth; Moringa Oleifera

Keywords

Moringa Oleifera; MI varnish; white spot lesions; remineralization; DIAGNOdent; Nyvad criteria

Outcome Measures

Primary Outcomes (1)

• Remineralization efficacy

  The DIAGNOdent will be used to quantify objectively the white spot lesions. For every patient, measurements with the DIAGNOdent will be performed and calibrated on a sound enamel (incisal one third of the central incisor) before actual readings. The teeth will be scanned carefully with the tip held in contact with the tooth surface and tilted around the measuring site so that fluorescence could be collected from all directions. Maximum reading will be recorded Singh et al.,(2016). DIAGNOdent scores: Shalaan et al.,(2023) * Score 1: 0-4 (healthy tooth structure) * Score 2: 5-10 (outer half enamel caries) * Score 3: 11-20 (inner half enamel caries) * Score 4: 21+ (dentin caries).

  baseline, 3 months and 6 months

Secondary Outcomes (1)

• Caries lesion activity assessment

  baseline, 3 months and 6 months

Study Arms (2)

Moringa Oleifera based varnish

EXPERIMENTAL

Moring Oleifera Varnish application Using a disposable bond brush, the varnish will be painted on the diagnosed surfaces, then the patient will be instructed to avoid brushing or flossing and to avoid hard and sticky food or any products that may contain alcohol (oral rinses, beverages, etc.) for the next 4 hours after application.

Other: Moringa Oleifera

MI varnish

ACTIVE COMPARATOR

MI Varnish application The varnish will be applied on the clean surfaces according to manufacturer instructions as follows: 1. The foil cover of the MI Varnish unit dosage bottle will be peeled-off and MI Varnish will be stirred with the disposable brush before application. 2. The surfaces will be covered with a thin uniform layer using a disposable bond brush to avoid clumping. 3. The area will be allowed to become wet to ensure the setting of the varnish.

Other: Varnish

Interventions

Moringa Oleifera OTHER

Moring Oleifera Varnish application Using a disposable bond brush, the varnish will be painted on the diagnosed surfaces, then the patient will be instructed to avoid brushing or flossing and to avoid hard and sticky food or any products that may contain alcohol (oral rinses, beverages, etc.) for the next 4 hours after application.

Moringa Oleifera based varnish

Varnish OTHER

MI Varnish application The varnish will be applied on the clean surfaces according to manufacturer instructions as follows: 1. The foil cover of the MI Varnish unit dosage bottle will be peeled-off and MI Varnish will be stirred with the disposable brush before application. 2. The surfaces will be covered with a thin uniform layer using a disposable bond brush to avoid clumping. 3. The area will be allowed to become wet to ensure the setting of the varnish.

MI varnish

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Presentation with at least one active WSLs on the study teeth at the start of the study.
• Good oral hygiene.
• Co-operative patients approving to participate in the trial.
• Active non-cavitated initial carious lesions (ICDAS 1\&2)
• DIAGNOdent score between (8-15)
• Vital teeth with no signs or symptoms of irreversible pulpitis.
• No signs of clinical mobility.
• Teeth with healthy periodontium.

You may not qualify if:

• Participants with parafunctional habits or bruxism.
• Participants with dry mouth.
• Participants with systemic diseases or disabilities that may affect participation.
• Heavy smoking.
• Pregnancy.
• Lack of compliance.
• Severe or active periodontal disease.
• Cognitive impairment
• DIAGNOdent score less than 8 and more than 15
• Untreated cavitated lesions or extensive restorations on the facial surfaces of the study teeth
• Intrinsic or extremely heavy extrinsic staining
• Periapical pathosis or signs of pulpal pathology.
• Non-vital tooth.
• Signs of pathological wear.
• Endodontically treated tooth.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hend Taha Hanafi Mahmoud

Cairo, Cairo Governorate, 02022, Egypt

Location

Related Publications (9)

• Younis SH, Obeid RF, Ammar MM. Subsurface enamel remineralization by Lyophilized Moringa leaf extract loaded varnish. Heliyon. 2020 Sep 28;6(9):e05054. doi: 10.1016/j.heliyon.2020.e05054. eCollection 2020 Sep.

  PMID: 33015394 BACKGROUND

• Singh S, Singh SP, Goyal A, Utreja AK, Jena AK. Effects of various remineralizing agents on the outcome of post-orthodontic white spot lesions (WSLs): a clinical trial. Prog Orthod. 2016 Dec;17(1):25. doi: 10.1186/s40510-016-0138-9. Epub 2016 Aug 2.

  PMID: 27480987 BACKGROUND

• Obeid RF, Ammar MM, Younis SH. Dentinomimetics and cementomimetics of Moringa oleifera leaves extract. Sci Rep. 2023 Nov 7;13(1):19243. doi: 10.1038/s41598-023-46656-1.

  PMID: 37935743 BACKGROUND

• Nyvad B, Baelum V. Nyvad Criteria for Caries Lesion Activity and Severity Assessment: A Validated Approach for Clinical Management and Research. Caries Res. 2018;52(5):397-405. doi: 10.1159/000480522. Epub 2018 Mar 5.

  PMID: 29506010 BACKGROUND

• Malcangi G, Patano A, Morolla R, De Santis M, Piras F, Settanni V, Mancini A, Di Venere D, Inchingolo F, Inchingolo AD, Dipalma G, Inchingolo AM. Analysis of Dental Enamel Remineralization: A Systematic Review of Technique Comparisons. Bioengineering (Basel). 2023 Apr 12;10(4):472. doi: 10.3390/bioengineering10040472.

  PMID: 37106659 BACKGROUND

• Jwa SK. Efficacy of Moringa oleifera Leaf Extracts against Cariogenic Biofilm. Prev Nutr Food Sci. 2019 Sep;24(3):308-312. doi: 10.3746/pnf.2019.24.3.308. Epub 2019 Sep 30.

  PMID: 31608256 BACKGROUND

• Essam Eliwa M, Mohamed Y, Hossam E. Enamel remineralisation prospect of Moringa Oleifera hydrogel, eggshell hydrogel versus sodium fluoride varnish on artificially demineralised primary teeth: in vitro study. Acta Odontol Scand. 2024 May 6;83:264-272. doi: 10.2340/aos.v83.40623.

  PMID: 38709122 BACKGROUND

• Duarte K, Thomas B, Varma SR, Kamath V, Shetty B, Kuduruthullah S, Nambiar M. Antiplaque Efficacy of a Novel Moringa oleifera Dentifrice: A Randomized Clinical Crossover Study. Eur J Dent. 2022 Oct;16(4):768-774. doi: 10.1055/s-0041-1736418. Epub 2022 Jan 11.

  PMID: 35016231 BACKGROUND

• Bakry AS, Abbassy MA. Increasing the efficiency of CPP-ACP to remineralize enamel white spot lesions. J Dent. 2018 Sep;76:52-57. doi: 10.1016/j.jdent.2018.06.006. Epub 2018 Jun 19.

  PMID: 29933004 BACKGROUND

MeSH Terms

Interventions

flocculant protein MO 2.1, Moringa oleifera; Paint

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Ahmed Zohair El-Hoshy, professor at Cairo University

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hend Taha Mahmoud, Phd candidate

CONTACT

+201028137519; hend.taha@dentistry.cu.edu.eg

Dina Mohamed Kamal, Lecturer at cairo university

CONTACT

01122551800; dina.kamal@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd candidate

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: May 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)