White Spot Lesion of ToothPhase 3NCT04994314
White Spot Lesions Prevention During Orthodontic Fixed Appliance Treatment: a Randomized Clinical Trial
A Phase 3 study testing nCaF2 primer in people with White Spot Lesion of Tooth, run by University of Baghdad at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- White Spot Lesion of Tooth
- What is being tested?
- nCaF2 primer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteIraq
- Study dates
- 15 Feb 2021to 15 Feb 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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) .
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
Almina dental clinics
Karbala, 56001
Rawof R. Al Tuma, Msc, +9647901762894, raooftoma@yahoo.com
Hawraa Y. Yossif, Assisstant, +9647714147888, hawraayosif@yahoo.com
About this study
Official title: 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).
Read the 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
- Conditions
- White Spot Lesion of Tooth
- Being tested
- nCaF2 primer, Control primer
- Keywords
- white spot lesions, orthodontic primer, calcium fluoride nanoparticles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nCaF2 primerDrug
Also called Orthodontic primer containing calcium fluoride nanoparticles
Calcium fluoride nanoparticles was added to conventional orthodontic primers to develop bioactive primer. This primer was examined previously for its biological and physical properties
Control primerDrug
Also called TransbondTM XT orthodontic primer
Conventional orthodontic primer
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Drug: Control primer |
What is being measured
The primary outcome is the main question the study is designed to answer.
DIAGNOdent Pen scores change
assessing changes in the amount of enamel demineralization (DIAGNOdent Pen scores) between four time points:-
- baseline (before brackets bonding)
- after one month of brackets bonding
- after three months of brackets bonding
- after six months of brackets bonding
Measured: Six months
Secondary outcomes (1)
Streptococcus mutans load change
Quantitative detection of streptococcus mutans load changes (using real time PCR) between four time points:-
- baseline (before brackets bonding)
- after one month of brackets bonding
- after three months of brackets bonding
- after six months of brackets bonding
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start15 Feb 2021
- Primary completion16 Dec 2021 (estimated)
- Study completion15 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for White Spot Lesion of ToothStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study planned to be split mouth study with equal randomization (1:1 allocation ratio)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rawof Rasheed Jawad, University of Baghdad
- Investigators
- Yassir A. Yassir, PhD, Study director, Baghdad University- College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994314
- Sponsor's protocol ID
- calcium fluoride nanoparticles
- Status last verified
- Aug 2021
- First submitted
- 27 Jul 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36049047
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Calcium Fluoride Nanoparticles in Prevention of Demineralization During Orthodontic Fixed Appliance Treatment: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04994314
- Acronym / sponsor ID
- calcium fluoride nanoparticles
- Conditions
- White Spot Lesion of Tooth
- Keywords
- white spot lesions, orthodontic primer, calcium fluoride nanoparticles
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 16 Dec 2021 (estimated)
- Study completion
- 15 Feb 2022 (estimated)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study planned to be split mouth study with equal randomization (1:1 allocation ratio)
| Arm | Type | Receives |
|---|---|---|
| orthodontic primer containing calcium fluoride nanoparticles | Active comparator | Drug: nCaF2 primerFixed appliance for ten maxillary teeth and the contralateral mandibular teeth will be bonded using orthodontic primer containing calcium fluoride nanoparticles |
| Control primer | Placebo comparator | Drug: Control primerFixed 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients have
Key exclusion criteria (11 listed)
- Patients will be excluded if they had
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nCaF2 primerAlso: Orthodontic primer containing calcium fluoride nanoparticlesCalcium fluoride nanoparticles was added to conventional orthodontic primers to develop bioactive primer. This primer was examined previously for its biological and physical properties | Drug | orthodontic primer containing calcium fluoride nanoparticles |
| Control primerAlso: TransbondTM XT orthodontic primerConventional orthodontic primer | Drug | Control primer |
Primary outcome
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
1 secondary outcome
Streptococcus mutans load change
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Derived from this study: PubMed 36049047Al 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yassir A. Yassir, PhD study director
Baghdad University- College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nCaF2 primer in people with White Spot Lesion of Tooth, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rawof R. Al Tuma, MSc (+9647901762894, raooftoma@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DIAGNOdent Pen scores change (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04994314, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.