The Effect of Different Remineralizing Agents on White Spot Lesions and Dental Plaque During Orthodontic Retention

NCT04788550 | Unknown

• 1 other identifier: DGD_190005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Dental caries is a decay process that breaks down the tooth. The earliest clinical signs of active dental caries is seen as 'white spot lesions' (WSLs). WSLs causes porosity below the tooth surface as a result of demineralization that gives the lesion a milky white appearance. Many WSLs persevere even a decade after orthodontic appliance removal and remain a cosmetic problem. After removal of fixed appliances, a considerable improvement of WSLs can be seen during the first 6-24 months, but the degree of improvement varies between individuals. Two common bacteria in dental plaque causes caries: Streptococcus mutans (SM) and Lactobacillus acidophilus (LA) in the plaque contributes to the initiation and progression of caries, respectively. A major strategy suggested to deal with existing WSL after debond is to facilitate remineralisation using remineralising agents that contain fluoride. This can be from daily use of fluoridated toothpastes or having additional dose of fluoride application. Certain agents also contain casein phosphopeptide-stabilize amorphous calcium phosphate (CPP-ACP) that is believed to have an antibacterial and buffering effect on plaque and interfere the growth and adherence of bacteria.

Conditions

Orthodontic Appliance Complication

Keywords

White Spot Lesion; Bacterial count( Streptococcus & Lactobacillus count); Salivary profile(salivary flow rate, buffering capacity, pH)

Outcome Measures

Primary Outcomes (4)

• ICDAS score of the white spot lesion.

  Changes in WSL measured based on ICDAS score : * 0 No evidence of caries * 1 Initial caries * 2 Distinct visual change in enamel * 3 Localised enamel breakdown due to caries with no visible dentine * 4 Underlying dark shadow from dentine * 5 Distinct cavity with visible dentine * 6 Extensive distinct cavity with visible dentine

  18 months

• Optical changes (refractive index) of the white spot lesion.

  Changes in WSL measured in lesion depths (LD in μm).

  18 months

• Patient perception of the WSL

  Patient will be given a set of questionnaires at every follow up visit to assess the 1. Compliance to the remineralizing agent application 2. Perception on the WSL The perception will be based on the Likert scale

  18 months

• Dental plaque total bacterial count, Streptococcus count, Lactobacillus count.

  Plaque samples will be collected with sterile swabs from the enamel surface of each tooth with the identified WSL to measure the bacterial count. The colony forming units of each plates is enumerated and the cfu/mL will be calculated

  18 months

Secondary Outcomes (3)

• Salivary profile (salivary flow rate)

  18 months

• Salivary profile (buffering capacity)

  18 months

• Salivary profile (pH)

  18 months

Study Arms (3)

Toothpaste group

ACTIVE COMPARATOR

Control group using fluoridated toothpaste

Combination Product: Fluoridated toothpaste

Fluoride Varnish group

EXPERIMENTAL

Fluoride varnish (5% sodium fluoride) application on 3 months interval

Combination Product: fluoride varnish (5% sodium fluoride)

CPP-ACP plus crème group

EXPERIMENTAL

CPP-ACP plus crème application 2 times daily

Combination Product: CPP-ACP plus crème group

Interventions

Fluoridated toothpaste COMBINATION_PRODUCT

Group 1 will act as control group. Participants will be advised to brush twice daily using fluoridated toothpaste during the follow up periods. No other fluorides supplements will be allowed to use.

Also known as: Colgate® Maximum cavity protection great regular flavour

Toothpaste group

fluoride varnish (5% sodium fluoride) COMBINATION_PRODUCT

Approximately 0.5-1.0ml fluoride varnish will be applied on the tooth surface (labially) with the paint-on method fom canines to canines. No other fluorides supplements will be allowed to use.

Also known as: Colgate Duraphat 22,600 ppmF, 22,600 ppm Sodium Fluoride varnish

Fluoride Varnish group

CPP-ACP plus crème group COMBINATION_PRODUCT

Pea size CPP-ACP plus crème on the tooth surfaces using a clean fingers twice daily after brushing their teeth with fluoridated toothpaste. No other fluorides supplements will be allowed to use.

Also known as: GC Tooth Mousse Plus®

CPP-ACP plus crème group

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects on multibracket fixed appliance treatment
• Subjects with 2 or more bracketed surfaces with labial subsurface WSLs from
• upper right permanent canine (13) to upper left permanent canine (23) with an ICDAS II score of 1 and 2 will be selected.
• Indicated for thermoform or vacuum formed retainers on the upper arch.

You may not qualify if:

• Systemic diseases or any physical anomalies.
• Subjects with intention to move out from Klang Valley area for the next 1.5 years.
• Periodontal diseases (pocket depth of more than 3mm).
• Smoker.
• Severe fluorosis or any enamel abnormalities.
• Antimicrobial agents or antibiotic therapy within the past 3 months.
• Orthognathic surgery cases, cleft lip and palate.
• Single arched lower fixed orthodontic treatment.
• Milk protein and benzoate preservatives (a common preservatives) allergies.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Postgraduate Orthodontic Clinic, Faculty Of Dentistry, University Of Malaya

Kuala Lumpur, WP Kuala Lumpur, 50603, Malaysia

RECRUITING

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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

Central Study Contacts

Najwa Zakaria

CONTACT

0176476058; najwazakaria87@yahoo.com

Wan Nurazreena Wan Hassan

CONTACT

0379674802; wannurazreena@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Paediatric Dentistry and Orthodontics, Faculty of Dentistry

Model Details: Group 1 The participants in group one will act as control group as they will be advised in using fluoridated toothpaste to brush twice daily during the follow up periods Group 2 The participants in this group will received fluoride varnish (5% sodium fluoride) treatment Group 3 The participants will be advised to use pea size CPP-ACP plus crème (900ppm fluoride)

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 9, 2021
• Study Start: March 17, 2021
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)