Prospective Randomized Controlled Trial for Prevention of Demineralization During Fixed Orthodontic Treatment

NCT04342858 | Unknown Phase 2 DMC

• 1 other identifier: Version no.3; 27th Nov'17
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment with fixed orthodontic appliances is often associated with pain, which poses great challenges in the efficient brushing of the teeth thus making the teeth more vulnerable to plaque formation. Treatment duration with fixed orthodontic appliances usually extends to 18 months or even longer in some cases. This prolonged vulnerability to plaque formation frequently leads to demineralization of teeth. There is also an increase in the number of plaque retentive sites due to the fixed appliances, leading to a rapid change in the bacterial composition of the dental plaque, particularly in the number of acidogenic bacteria. The resulting enamel decalcification is also known as white spot lesions (WSLs), which is an early sign of demineralization of enamel. Enamel WSLs (EWSLs) can be observed even as early as four weeks from the start of fixed orthodontic treatment. The occurrence of EWSLs adjacent to the orthodontic brackets ranges from 15 to 85%. The incidence of EWSLs development is higher in orthodontic patients as compared to the development of similar lesions in non-orthodontic patients. These EWSLs are not aesthetically pleasing and is certainly unacceptable when it develops during fixed orthodontic treatment that is usually performed in patients who often seek such treatment to improve their aesthetics. Additionally, even if the outcome of fixed orthodontic treatment is superior from well-aligned teeth, aesthetics can be greatly compromised with EWSLs. Therefore, the prevention of such lesions is an important concern for orthodontists. Though professionally applied topical fluoride varnish helps in remineralization of EWSLs, an adequate supply of calcium and phosphate ions is essential for remineralization. Therefore, EWSLs on maxillary teeth could be prevented and remineralized by the use of advanced novel topical fluoride varnish with added calcium and phosphate-based delivery system.

Conditions

Demineralization, Tooth; Caries,Dental; White Spot Lesion

Keywords

orthodontics; demineralizatiion; fluoride; Diagnodent

Outcome Measures

Primary Outcomes (3)

• Change in Enamel White Spot Lesions index surface scores: Clinical evaluation (Subjective criteria)

  Changes in EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated clinically). The Gorelick's index is graded as: 0 (no lesion), 1(moderate lesion), 2 (severe lesion) and 3 (cavitation) with lower score representing good outcome and higher score representing poor outcome.

  24 months

• Change in Enamel White Spot Lesions index surface scores: Photographic evaluation (Subjective criteria)

  Changes in EWSLs surface scores (using Gorelick's index, 1982) among three study groups (evaluated photographically). The Gorelick's index is graded as: 0 (no lesion), 1(moderate lesion), 2 (severe lesion) and 3 (cavitation) with lower score representing good outcome and higher score representing poor outcome

  24 months

• Change in Laser fluoroscence values (Objective criteria)

  Changes in mean DIAGNOdent scores among three study groups. The DIAGNOdent values (or laser fluorescence values) are visible on the device as digital readings from 0 to 99 with higher readings representing poor outcomes and lower readings representing good outcomes.

  24 months

Secondary Outcomes (9)

• Enamel White Spot Lesions index surface scores: Clinical evaluation (Subjective criteria)

  6 months

• Enamel White Spot Lesions index surface scores: Clinical evaluation (Subjective criteria)

  12 months

• Enamel White Spot Lesions index surface scores: Clinical evaluation (Subjective criteria)

  18 months

• Enamel White Spot Lesions index surface scores: Photographic evaluation (Subjective criteria)

  6 months

• Enamel White Spot Lesions index surface scores: Photographic evaluation (Subjective criteria)

  12 months

Study Arms (3)

Standard of care

OTHER

Control will receive standard oral hygiene instructions (OHI every three months)

Other: Oral health education

Standard of care + Fluoride varnish

ACTIVE COMPARATOR

Intervention 1 will receive standard OHI and application of topical fluoride varnish containing 5% NaF (Duraphat varnish®, Colgate-Palmolive (UK) Ltd., Guildford, Surrey, UK) every three months

Drug: Fluoride Varnish

Standard of care + Fluoride varnish with Tricalcium phosphate

EXPERIMENTAL

Intervention 2 will receive standard OHI and application of topical fluoride varnish containing 5% NaF + TCP (Clinpro white varnishTM, 3M ESPE, St Paul, MN, USA) every three months

Drug: Fluoride Varnish with tricalcium phosphate

Interventions

Fluoride Varnish DRUG

Duraphat varnish®, Colgate-Palmolive (UK) Ltd., Guildford, Surrey, UK

Also known as: 5% Sodium fluoride varnish

Standard of care + Fluoride varnish

Fluoride Varnish with tricalcium phosphate DRUG

Clinpro white varnishTM, 3M ESPE, St Paul, MN, USA

Also known as: 5% Sodium fluoride varnish containing tri-calcium phosphate

Standard of care + Fluoride varnish with Tricalcium phosphate

Oral health education OTHER

Standard oral hygiene instructions every 3 months

Also known as: Oral hygiene instructions

Standard of care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects about to undergo multi-bracketed fixed orthodontic treatment will be invited to participate in this study.

You may not qualify if:

• History of fixed orthodontic treatment
• Presence of any developmental defects of enamel (DDE) on labial surfaces of teeth
• Presence of any dental anomalies or direct/indirect labial restorations on teeth
• History of long-term antibiotic usage
• Presence of untreated cavitated lesions
• Plaque level greater than 25%
• Patients requiring complicated orthognathic surgeries

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, 999077, Hong Kong

Location

MeSH Terms

Conditions

Tooth Demineralization; Dental Caries

Interventions

tricalcium phosphate; Health Education, Dental

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Dentistry; Environment and Public Health

Study Officials

• Cynthia KY Yiu, MDS, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A dental assistant will allocate the participants in the study to their respective groups. The examiner will not be informed about the study participant's group allocation information. The orthodontist performing the fixed orthodontic treatment will not know about the study participant's group allocation information as the topical fluoride varnish application in this study will be performed by another operator.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized controlled trial with three parallel groups. In the proposed study, individual participants, and not parts of the mouth, will serve as the unit of randomization. This approach unlike a split-mouth design will eliminate the problems of cross-contamination.

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 13, 2020
• Study Start: September 15, 2017
• Primary Completion: March 30, 2021
• Study Completion: July 30, 2021
• Last Updated: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)