NCT04994314

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

July 27, 2021

Last Update Submit

August 5, 2021

Conditions

White Spot Lesion of Tooth

Keywords

white spot lesionsorthodontic primercalcium fluoride nanoparticles

Outcome Measures

Primary Outcomes (1)

  • DIAGNOdent Pen scores change

    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 Outcomes (1)

  • Streptococcus mutans load change

    Six months

Study Arms (2)

orthodontic primer containing calcium fluoride nanoparticles

ACTIVE COMPARATOR

Fixed appliance for ten maxillary teeth and the contralateral mandibular teeth will be bonded using orthodontic primer containing calcium fluoride nanoparticles

Drug: nCaF2 primer

Control primer

PLACEBO COMPARATOR

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

Interventions

nCaF2 primerDRUG

Calcium fluoride nanoparticles was added to conventional orthodontic primers to develop bioactive primer. This primer was examined previously for its biological and physical properties

Also known as: Orthodontic primer containing calcium fluoride nanoparticles
orthodontic primer containing calcium fluoride nanoparticles
Control primerDRUG

Conventional orthodontic primer

Also known as: TransbondTM XT orthodontic primer
Control primer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Almina dental clinics

Karbala, 56001, Iraq

RECRUITING

Related Publications (1)

  • Al Tuma RR, Yassir YA. Effect of calcium fluoride nanoparticles in prevention of demineralization during orthodontic fixed appliance treatment: a randomized clinical trial. Eur J Orthod. 2023 Mar 31;45(2):122-132. doi: 10.1093/ejo/cjac055.

    PMID: 36049047DERIVED

Study Officials

  • Yassir A. Yassir, PhD

    Baghdad University- College of Dentistry

    STUDY DIRECTOR

Central Study Contacts

Rawof R. Al Tuma, MSc

CONTACT

+9647901762894raooftoma@yahoo.com

Yassir A. Yassir, PhD

CONTACT

+9647703919599yassirkyassir@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
This study proposed to be double blinded (the patients, investigators and the outcome assessors)
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study planned to be split mouth study with equal randomization (1:1 allocation ratio)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 6, 2021

Study Start

February 15, 2021

Primary Completion

December 16, 2021

Study Completion

February 15, 2022

Last Updated

August 6, 2021

Record last verified: 2021-08

Locations

IR(1)