White Spot Lesions Treatment in Orthodontic

NCT06051981 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: FPGRP/2023/780
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to investigate the effectiveness of a new treatment for demineralized white spot lesions (WSLs) after fixed appliance therapy. The trial will consist of four parallel groups: control, Fluoride Varnish (FV), Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP), and Resin Infiltration (RI) groups. Patients will be recruited from Riyadh Elm University's electronic record system and contacted by phone. They will be given an appointment to visit the dental clinic. A total of 22 patients with WSLs will be selected for the study. Two examiners will perform dental examinations using a dental mirror and a ball-ended probe to code the WSL against the ICDAS system. The level of agreement between the two examiners will be assessed using reliability analysis, with an agreement level of above 80% considered. Buccal WSLs will be defined as those that extend from the center of the buccal to either the mesial or distal surface. WSLs coded 3 or higher will be excluded from further examination and treated accordingly.

Conditions

White Spot Lesion

Keywords

Fixed orthodontic Appliances; White Spot Lesion; Fluoride Varnish; Casein Phosphopeptide-Amorphous Calcium Phosphate; Resin Infiltration; Laser Fluorescence

Outcome Measures

Primary Outcomes (1)

• Change in mineral contents of enamel

  The maximum light fluorescence value for each tooth with a white spot lesion will be determined using a DIAGNODent flat tip, following manufacturer's instructions. The DIAGNOdent scale will be used to measure the mineral content of enamel, with values ranging from 0 to 20.

  Baseline pre-treatment (T1), immediately post-treatment (T2), and three months post-treatment (T3)

Study Arms (4)

Fluoride Varnish (control)

EXPERIMENTAL

The study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. In group I, FV EnamelastTM will be applied to all teeth using compressed air and cotton rolls, leaving them to dry for one minute. Patients will be advised to avoid eating, drinking, or brushing for 3-4 hours after application.

Drug: 5% sodium fluoride

Intensive Fluoride Varnish

EXPERIMENTAL

The study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. Patients in group II Intensive FV will be applied three times a week for a week (every two days).

Drug: Intensive 5% sodium fluoride

Casein Phosphopeptide-Amorphous Calcium Phosphate

EXPERIMENTAL

The study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. Group III (CPP-ACP) uses Tooth Mousse® for 12 weeks, will be applied after daily brushing with traditional toothpaste, left intact for 180 seconds, and rinsed with distilled water.

Drug: Casein Phosphopeptide-Amorphous Calcium Phosphate

Resin Infiltration

EXPERIMENTAL

The study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. Group IV uses ICON® resin infiltration, applying a 15% hydrochloric acid solution, rinsing with water, drying, and applying ICON-Dry. Excess resin is removed, and a light curing process is performed. The roughened enamel surface is polished using composite resin polish discs and cups.

Drug: Resin infiltration

Interventions

Intensive 5% sodium fluoride DRUG

Intensive FV will be applied three times a week for a week (every two days).

Also known as: EnamelastTM

Intensive Fluoride Varnish

5% sodium fluoride DRUG

a flavored xylitol-sweetened, 5% sodium fluoride in a resin carrier delivered in a 1.2 ml syringe or in a 0.4 ml unit, Ultradent, USA) will be applied on all teeth according to the manufacturer's instructions.

Also known as: FV EnamelastTM

Fluoride Varnish (control)

Casein Phosphopeptide-Amorphous Calcium Phosphate DRUG

for 12 weeks. A thin layer from Tooth Mousse™ will be applied to the teeth after daily brushing with traditional toothpaste and left intact for 180 seconds before rinsing with distilled water

Also known as: (CPP-ACP), Tooth Mousse® (MI Paste®) (GC Corporation, Tokyo, Japan)

Casein Phosphopeptide-Amorphous Calcium Phosphate

Resin infiltration DRUG

resin infiltration will be applied as specified by the manufacturer.

Also known as: ICON® (DMG, Hamburg, Germany)

Resin Infiltration

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Post orthodontic patients with one WSLs on buccal surface of tooth with ICDAS Code 1 or 2.
• Agreeing to participate in the study by singing the study informed consent.
• For younger patients parents agree to provide consent for child participation in the study.

You may not qualify if:

• Developmental defects of dental hard tissue
• Patients who have systemic disease or under medications that usually cause an increased risk of oral caries.
• Patients who are allergic to Fluoride varnish, CPP-ACP and resin infiltration.

Sponsors & Collaborators

• Riyadh Elm University: lead

Related Publications (13)

• Boersma JG, van der Veen MH, Lagerweij MD, Bokhout B, Prahl-Andersen B. Caries prevalence measured with QLF after treatment with fixed orthodontic appliances: influencing factors. Caries Res. 2005 Jan-Feb;39(1):41-7. doi: 10.1159/000081655.

  PMID: 15591733 BACKGROUND

• Ferreira JM, Silva MF, Oliveira AF, Sampaio FC. Evaluation of different methods for monitoring incipient carious lesions in smooth surfaces under fluoride varnish therapy. Int J Paediatr Dent. 2008 Jul;18(4):300-5. doi: 10.1111/j.1365-263X.2007.00879.x.

  PMID: 18554336 BACKGROUND

• Lussi A, Megert B, Longbottom C, Reich E, Francescut P. Clinical performance of a laser fluorescence device for detection of occlusal caries lesions. Eur J Oral Sci. 2001 Feb;109(1):14-9. doi: 10.1034/j.1600-0722.2001.109001014.x.

  PMID: 11330928 BACKGROUND

• Makhija SK, Bader JD, Shugars DA, Litaker MS, Nagarkar S, Gordan VV, Rindal DB, Pihlstrom DJ, Mungia R, Meyerowitz C, Gilbert GH; National Dental Practice-Based Research Network (PBRN) Collaborative Group. Influence of 2 caries-detecting devices on clinical decision making and lesion depth for suspicious occlusal lesions: A randomized trial from The National Dental Practice-Based Research Network. J Am Dent Assoc. 2018 Apr;149(4):299-307.e1. doi: 10.1016/j.adaj.2017.11.001. Epub 2018 Feb 21.

  PMID: 29475554 BACKGROUND

• Melrose CA, Appleton J, Lovius BB. A scanning electron microscopic study of early enamel caries formed in vivo beneath orthodontic bands. Br J Orthod. 1996 Feb;23(1):43-7. doi: 10.1179/bjo.23.1.43.

  PMID: 8652497 BACKGROUND

• Migliorati M, Isaia L, Cassaro A, Rivetti A, Silvestrini-Biavati F, Gastaldo L, Piccardo I, Dalessandri D, Silvestrini-Biavati A. Efficacy of professional hygiene and prophylaxis on preventing plaque increase in orthodontic patients with multibracket appliances: a systematic review. Eur J Orthod. 2015 Jun;37(3):297-307. doi: 10.1093/ejo/cju044. Epub 2014 Sep 22.

  PMID: 25246605 BACKGROUND

• Aljehani A, Yousif MA, Angmar-Mansson B, Shi XQ. Longitudinal quantification of incipient carious lesions in postorthodontic patients using a fluorescence method. Eur J Oral Sci. 2006 Oct;114(5):430-4. doi: 10.1111/j.1600-0722.2006.00395.x.

  PMID: 17026510 RESULT

• 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 RESULT

• Kau CH, Wang J, Palombini A, Abou-Kheir N, Christou T. Effect of fluoride dentifrices on white spot lesions during orthodontic treatment: A randomized trial. Angle Orthod. 2019 May;89(3):365-371. doi: 10.2319/051818-371.1. Epub 2019 Feb 5.

  PMID: 30719933 RESULT

• Llena C, Leyda AM, Forner L. CPP-ACP and CPP-ACFP versus fluoride varnish in remineralisation of early caries lesions. A prospective study. Eur J Paediatr Dent. 2015 Sep;16(3):181-6.

  PMID: 26418918 RESULT

• Meyer-Lueckel H, Paris S. Progression of artificial enamel caries lesions after infiltration with experimental light curing resins. Caries Res. 2008;42(2):117-24. doi: 10.1159/000118631. Epub 2008 Feb 28.

  PMID: 18305389 RESULT

• Nascimento PL, Fernandes MT, Figueiredo FE, Faria-E-Silva AL. Fluoride-Releasing Materials to Prevent White Spot Lesions around Orthodontic Brackets: A Systematic Review. Braz Dent J. 2016 Jan-Feb;27(1):101-7. doi: 10.1590/0103-6440201600482.

  PMID: 27007355 RESULT

• Sonesson M, Brechter A, Lindman R, Abdulraheem S, Twetman S. Fluoride varnish for white spot lesion prevention during orthodontic treatment: results of a randomized controlled trial 1 year after debonding. Eur J Orthod. 2021 Aug 3;43(4):473-477. doi: 10.1093/ejo/cjaa055.

  PMID: 33009565 RESULT

Related Links

• CPP-ACP and CPP-ACFP versus fluoride varnish in remineralisation of early caries lesions. A prospective study

MeSH Terms

Interventions

Sodium Fluoride; casein phosphopeptide-amorphous calcium phosphate nanocomplex

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Samira Algasn, BDS

  Riyadh Elm University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samira Algasn, BDS

CONTACT

‭966500929996‬; samira.m.algasn2021@student.riyadh.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A web based research randomizer software will be used to generate a random sequence number to allocate the participants to different groups. The allocation will be kept concealed from patients and examiners using sequentially numbered identical containers containing experimental materials (remineralizing agents) to ensure the double blindness of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Student

Model Details: Once the FV has been applied, the examiners at Riyadh Elm University will do a visual inspection and take LF measurements (T2) on all the areas that were marked as WSL on the initial photos. The LF measurement will be carried out by the same inspectors who carried out the visual inspection. At the end of treatment for groups II, III, IV, a visual examination and LF measurements (T2) will be conducted by the same examiners. At the next inspection (after 3 months (T3)), LF measurements will be carried out on all areas that were marked as WSL on the original photos, whether they are still existing WSL areas or they will be changed to WSL free areas.

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: October 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share