White Spot Lesions Prevention During Orthodontic Fixed Appliance Treatment: a Randomized Clinical Trial

August 5, 2021 updated by: Rawof Rasheed Jawad, University of Baghdad

Effect of Calcium Fluoride Nanoparticles in Prevention of Demineralization During Orthodontic Fixed Appliance Treatment: a Randomized Clinical Trial

The aim of this study is to evaluate the effectiveness of calcium fluoride nanoparticles containing orthodontic primer in preventing or decreasing the incidence WSLs over a period of 6 months in patients with fixed orthodontic appliances.

This study proposed to be double blinded, split mouth, randomized clinical trial, with equal randomization (1:1 allocation ratio).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The sample was selected and recruited from patients attending two centres (Orthodontic Department at Karbala Governmental Specialized Dental Center and Almina Dental Private Clinics/Karbala), but the bonding and follow up sessions were done in Almina Dental Private Clinics/Karbala. Patient recruitment was done according to specified inclusion and exclusion criteria.

Intervention procedure planned to be by bonding fixed orthodontic appliances to all patients. The four quadrants of the mouth will be divided into two groups (Group 1 and 2), with one group, the upper right and lower left quadrants bonded with nCaF2 resin, while the upper left and lower right quadrants bonded with control resin. For the other group, the reverse will be carried out. Then, by the use of a computer random number generator, the two groups will be randomly allocated, and each number in the random table will be given a study number in order to create the final Allocation Table for the participants in the study (which contained the study number and allocation group). the primary planned to be measured by DIAGNOdent Pen 2190 device to measure enamel demineralization objectively, while the secondary objective planned to be quantitative detection of Streptococcus mutans bacteria by using real-time PCR

Study Type

Interventional

Enrollment (Anticipated)

31

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Iraq
      • Karbala, Iraq, 56001
        • Recruiting
        • Almina dental clinics
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients have

    1. Fully erupted permanent teeth (regardless the third molar),
    2. Indication to have orthodontic treatment without extraction
    3. Fair or good oral hygiene before or after oral hygiene instruction

Exclusion Criteria:

  • Patients will be excluded if they had

    1. Previous orthodontic treatment or extractions
    2. Missing teeth
    3. Active enamel caries determined by clinical examination
    4. Patients with enamel hypoplasia, dental fluorosis or tetracycline pigmentation
    5. Labial restorations
    6. Severe periodontal diseases determined according to PDI index by Sigurd P. Ramfjord (Ramfjord, 1967)
    7. Craniofacial syndromes such as clefts
    8. Xerostomia determined from clinical history of the patient
    9. Severely rotated teeth (limiting the appearance of buccal surfaces)
    10. Heavy smokers determined by accounting the number of cigarettes per day and time to the first cigarette of the day (Heatherton et al., 1989) .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: orthodontic primer containing calcium fluoride nanoparticles
Fixed appliance for ten maxillary teeth and the contralateral mandibular teeth will be bonded using orthodontic primer containing calcium fluoride nanoparticles
Drug: nCaF2 primer
Calcium fluoride nanoparticles was added to conventional orthodontic primers to develop bioactive primer. This primer was examined previously for its biological and physical properties
Other Names:
  • Orthodontic primer containing calcium fluoride nanoparticles
Placebo Comparator: Control primer
Fixed appliance for ten maxillary teeth (contralateral to experimental ten side)and the contralateral mandibular teeth will be bonded using conventional primer (TransbondTM XT orthodontic primers (3M-Unitek, Monrovia, USA)
Drug: Control primer
Conventional orthodontic primer
Other Names:
  • TransbondTM XT orthodontic primer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DIAGNOdent Pen scores change
Time Frame: Six months

assessing changes in the amount of enamel demineralization (DIAGNOdent Pen scores) between four time points:-

  1. baseline (before brackets bonding)
  2. after one month of brackets bonding
  3. after three months of brackets bonding
  4. after six months of brackets bonding
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Streptococcus mutans load change
Time Frame: Six months

Quantitative detection of streptococcus mutans load changes (using real time PCR) between four time points:-

  1. baseline (before brackets bonding)
  2. after one month of brackets bonding
  3. after three months of brackets bonding
  4. after six months of brackets bonding
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Investigators

  • Study Director: Yassir A. Yassir, PhD, Baghdad University- College of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2021

Primary Completion (Anticipated)

December 16, 2021

Study Completion (Anticipated)

February 15, 2022

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

August 5, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • calcium fluoride nanoparticles

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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