Effect of BG Versus RI on the Depth of WSL

NCT07770724 | Not Yet Recruiting

• 1 other identifier: IIDC/IRC/2024 Ayesha Islam
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this in vitro study is to assess the mean lesion depth improvement and hardness of artificial white spot lesions by comparing the effects of bioactive glass toothpaste and resin infiltration (ICON).

Conditions

White Spot Lesions

Keywords

white spot lesions; orthodontic brackets; resin infiltration; Fluoride toothpaste

Outcome Measures

Primary Outcomes (2)

• Scanning Electron Microscopy

  Changes in baseline lesion depth were assessed using scanning electron microscopy. Scanning electron microscopy is used to assess lesion depth before and after treatment with remineralizing agents. Lesion depth is measured in microns. Comparison is made by calculating the average depth of treated samples against untreated demineralized control samples.

  4th week

• Vickers Microhardness Test

  Changes from baseline microhardness tests are used to measure changes in surface hardness before and after remineralization. Sound or artificially demineralized enamel (acid-etched or caries-like lesions) is tested first to set a control value. Agents like fluoride varnishes, CPP-ACP (Casein Phosphopeptide-Amorphous Calcium Phosphate), or bioactive glass are applied over cycles. The percentage surface hardness measures how much demineralized enamel is hardened after remineralization treatment relative to original healthy baseline.

  4th week

Study Arms (3)

Bioactive glass

ACTIVE COMPARATOR

toothpaste for white spot lesions

Other: Bioactive Glass (NovaMin)

Resin Infiltration(ICON)

ACTIVE COMPARATOR

Infiltration on the tooth surface to treat white spot lesions

Other: Resin Infiltration (ICON)

Fluoride toothpaste

PLACEBO COMPARATOR

Fluoride content treats the white spot lesion

Other: Fluoride Toothpaste

Interventions

Bioactive Glass (NovaMin) OTHER

A carbonated beverage (Coca Cola, Pakistan ltd) will be used for artificial white spot lesion formation. The pH of the beverage will be 4-4.5 at 37ºC. The teeth will be immersed in demineralization solution for 4 weeks before treatment. The solution will be changed every 48 hrs. to keep the pH constant. After demineralization specimens will be washed with distilled deionized water (DDW). The tooth will have a white spot lesion only on the buccal surface. A sufficient amount of 5% bioactive glass (Biomin F T/P) was applied on the tooth surface for three minutes using a tooth brush. The toothpaste remained on the surface for an additional 30 minutes.

Bioactive glass

Resin Infiltration (ICON) OTHER

A carbonated beverage (Coca Cola, Pakistan ltd) was used for artificial white spot lesion formation. The pH of the beverage was 4-4.5 at 37ºC. The teeth were be immersed in demineralization solution for 4 weeks before treatment. The solution was changed every 48 hrs. to keep the pH constant. After demineralization specimens were washed with distilled deionized water (DDW). The tooth would have a white spot lesion only on the buccal surface. Resin infiltration (ICON) infiltration will be applied according to manufacture as following: * Application of Icon Etch (15% HCL gel) for 2 minutes. * Water rinsing and air drying for 30 sec. * Application of Icon-dry (ethanol) for 30 sec. * Air drying * Application of Icon Infiltrant for 3 minutes. * Light curing for 40 seconds.

Resin Infiltration(ICON)

Fluoride Toothpaste OTHER

A carbonated beverage (Coca Cola, Pakistan ltd) was used for artificial white spot lesion formation. The pH of the beverage will be 4-4.5 at 37ºC. The teeth were immersed in demineralization solution for 4 weeks before treatment. The solution was changed every 48 hrs. to keep the pH constant. After demineralization specimens was washed with distilled deionized water (DDW). The tooth would have a white spot lesion only on the buccal surface. The teeth were cleaned and dried first. 5% Sodium fluoride (Enamelist) varnish was applied on tooth surface with disposable tooth brush. The varnish remained undisturbed on teeth for 4 hours.

Fluoride toothpaste

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Upper and lower premolars will be collected from patients undergoing extractions.
• The teeth should be healthy with no carious lesions.
• The crown and root morphology of teeth should be normal.
• The extracted premolar teeth of patients should have no history of previous dental treatment.

You may not qualify if:

• Fractured premolars due to any cause.
• Loss of enamel due to parafunctional habits.
• Presence of enamel anomalies (amelogenesis imperfecta, hypoplasia etc.).
• Presence of stains, demineralization, decay, fluorosis and restorations

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Islamic International Dental Hospital

Islamabad, Capital, 44000, Pakistan

Location

Related Publications (6)

• Eckstein A, Helms HJ, Knosel M. Camouflage effects following resin infiltration of postorthodontic white-spot lesions in vivo: One-year follow-up. Angle Orthod. 2015 May;85(3):374-80. doi: 10.2319/050914-334.1. Epub 2014 Aug 15.

  PMID: 25126675 BACKGROUND

• Shan D, He Y, Gao M, Liu H, Zhu Y, Liao L, Hadaegh F, Long H, Lai W. A comparison of resin infiltration and microabrasion for postorthodontic white spot lesion. Am J Orthod Dentofacial Orthop. 2021 Oct;160(4):516-522. doi: 10.1016/j.ajodo.2020.04.039. Epub 2021 Jul 31.

  PMID: 34344556 BACKGROUND

• Meyer-Lueckel H, Paris S. Infiltration of natural caries lesions with experimental resins differing in penetration coefficients and ethanol addition. Caries Res. 2010;44(4):408-14. doi: 10.1159/000318223. Epub 2010 Aug 17.

  PMID: 20714153 BACKGROUND

• Baeshen HA, Lingstrom P, Birkhed D. Effect of fluoridated chewing sticks (Miswaks) on white spot lesions in postorthodontic patients. Am J Orthod Dentofacial Orthop. 2011 Sep;140(3):291-7. doi: 10.1016/j.ajodo.2010.04.034.

  PMID: 21889073 BACKGROUND

• Hu H, Feng C, Jiang Z, Wang L, Shrestha S, Su X, Shu Y, Ge L, Lai W, Hua F, Long H. Effectiveness of remineralising agents in prevention and treatment of orthodontically induced white spot lesions: a protocol for a systematic review incorporating network meta-analysis. Syst Rev. 2019 Dec 29;8(1):339. doi: 10.1186/s13643-019-1253-8.

  PMID: 31884975 BACKGROUND

• Kannan A, Padmanabhan S. Comparative evaluation of Icon(R) resin infiltration and Clinpro XT varnish on colour and fluorescence changes of white spot lesions: a randomized controlled trial. Prog Orthod. 2019 Jun 17;20(1):23. doi: 10.1186/s40510-019-0276-y.

  PMID: 31204437 BACKGROUND

MeSH Terms

Interventions

NovaMin

Study Officials

• Ulfat Bashir, MDS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

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

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)