Prevention of White Spot Lesions in Patients Undergoing Orthodontic TreatmentNCT07325643

Effect of Hydroxyapatite Toothpaste and Mouthwash in Preventing White Spot Lesions During Orthodontic Treatment

A study testing Hydroxyapatite Toothpaste and Hydroxyapatite Mouthwash in people with Prevention of White Spot Lesions in Patients Undergoing Orthodontic Treatment, run by Heba Tahseen Almasri at 1 site in Iraq.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This study aims to evaluate the effect of hydroxyapatite-containing toothpaste and mouthwash in preventing white spot lesions in patients undergoing orthodontic treatment. Participants: 75 patients will be divided into three groups: Group A: Participants will brush their teeth three times a day using hydroxyapatite… Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Prevention of White Spot Lesions in Patients Undergoing Orthodontic Treatment
What is being tested?: Hydroxyapatite Toothpaste and Hydroxyapatite Mouthwash
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 75 participants
Where: 1 siteIraq
Study dates: 20 Nov 2025to 20 Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

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
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

1. History of previous orthodontic treatment. 2. Bleaching or topical fluoridation within the last six months. 3. Severely rotated any of the study teeth (limiting the appearance of facial surfaces).
4. Visible signs of caries, fluorosis, hypocalcification, or other developmental defects. 5. Restoration on the labial surface of the study teeth. 6. Systemic or endocrine conditions (e.g., cardiac pacemakers, diabetes mellitus).
7. Craniofacial anomalies and clefts.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Heba Tahseen Almasri, BSc, MSc (candidate) contact

009647810440125

heba53104@gmail.com

Iraq1 site, 1 recruiting

University of Baghdad - College of Dentistry / Orthodontic Clinic
Baghdad
Heba Tahseen Almasri, BSc, MSc (candidate), 009647810440125, heba53104@gmail.com
Recruiting

Other trials in Iraq

About this study

Official title: Effectiveness of a Hydroxyapatite-Containing Toothpaste Versus Mouthwash in Preventing White-Spot Lesions During Fixed-Appliance Orthodontic Treatment: A Randomized Clinical Trial

This study aims to evaluate the effect of hydroxyapatite-containing toothpaste and mouthwash in preventing white spot lesions in patients undergoing orthodontic treatment.

Participants: 75 patients will be divided into three groups:

Group A: Participants will brush their teeth three times a day using hydroxyapatite toothpaste and rinse twice a day with a placebo mouthwash.
Group B: Participants will brush their teeth three times a day using fluoride toothpaste and rinse twice a day with hydroxyapatite mouthwash.
Group C (Control Group): Participants will brush their teeth three times a day using fluoride toothpaste and rinse twice a day with a placebo mouthwash.

Patients will be followed during their orthodontic treatment to assess the development of white spot lesions.

The study is safe and involves no surgical procedures or risky medications, and will be conducted under the supervision of Principal Investigator Heba Masri after obtaining ethical approval.

Read the detailed description

This randomized, three-group study aims to evaluate the effectiveness of hydroxyapatite in preventing white spot lesions during orthodontic treatment in patients who initially do not have these lesions.

Study Design:

Total Participants: 75 patients (25 per group)
Duration: Throughout orthodontic treatment
Groups:
Group A: Brush teeth three times daily with hydroxyapatite toothpaste and rinse twice daily with placebo mouthwash.
Group B: Brush teeth three times daily with fluoride toothpaste and rinse twice daily with hydroxyapatite mouthwash.
Group C (Control): Brush teeth three times daily with fluoride toothpaste and rinse twice daily with placebo mouthwash.

Outcome Assessments:

All assessments of white-spot lesions will be performed using Diagnodent Pen, Gorlick index (GI), digital photographs, Gingival Bleeding Index (GBI), Plaque Index (PI), and salivary pH measurements.

Ethical Considerations:

All participants will sign informed consent prior to joining the study.
The study was approved by the Ethics Committee, College of Dentistry, University of Baghdad.
This study involves low-risk interventions (toothpaste and mouthwash) and does not use U.S. FDA-regulated drugs or devices.

Study Objective:

To determine whether hydroxyapatite-containing toothpaste and/or mouthwash is more effective than conventional products in preventing white spot lesions during orthodontic treatment.

Conditions: Prevention of White Spot Lesions in Patients Undergoing Orthodontic Treatment
Being tested: Hydroxyapatite Toothpaste, Hydroxyapatite Mouthwash, Fluoride Toothpaste + Placebo Mouthwash

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hydroxyapatite ToothpasteDietary supplement
Participants will brush their teeth three times daily with hydroxyapatite-containing toothpaste to evaluate its effect on preventing white spot lesions during orthodontic treatment.
Hydroxyapatite MouthwashDietary supplement
Participants will rinse their mouth twice daily with hydroxyapatite-containing mouthwash to assess its preventive effect on white spot lesions in orthodontic patients.
Fluoride Toothpaste + Placebo MouthwashOther
Participants will brush their teeth three times daily with fluoride toothpaste and rinse twice daily with placebo mouthwash, serving as the control group for comparison with hydroxyapatite interventions.

Study groups in NCT07325643
Study group	Role	What they receive
HAp toothpaste + placebo mouth wash	Experimental	HAp toothpaste + placebo mouthwash * Arm Description: Participants will brush their teeth three times daily with hydroxyapatite toothpaste and rinse twice daily with a placebo mouthwash. Receives: Dietary Supplement: Hydroxyapatite Toothpaste
HAp mouthwash + fl toothpaste	Experimental	Fluoride toothpaste + HAp mouthwash * Arm Description: Participants will brush their teeth three times daily with fluoride toothpaste and rinse twice daily with HAp mouthwash. Receives: Dietary Supplement: Hydroxyapatite Mouthwash
Fluoride toothpaste + placebo mouthwash	Placebo comparator	Fluoride toothpaste + placebo mouthwash * Arm Description: Participants will brush their teeth three times daily with fluoride toothpaste and rinse twice daily with a placebo mouthwash. Receives: Other: Fluoride Toothpaste + Placebo Mouthwash

What is being measured

The primary outcome is the main question the study is designed to answer.

Severity of White Spot Lesions assessed by Gorelick Index
Severity of white spot lesions on labial tooth surfaces assessed using the Gorelick index during orthodontic treatment.
Time Frame:
Baseline to 6 months
Unit of Measure:
Score
Measured: Baseline, 1,3 months, and 6 months
Enamel Demineralization assessed by DIAGNOdent
Enamel demineralization level measured using DIAGNOdent laser fluorescence device during orthodontic treatment.
Unit of Measure:
DIAGNOdent score (laser fluorescence units)
Measured: Baseline, 1,3 months, and 6 months

Secondary outcomes (3)

Plaque Index
Plaque accumulation assessed using a standardized plaque index during orthodontic treatment.
Measured: Baseline, 1, 3 months, 6 months
Gingival Bleeding Index
Gingival bleeding assessed using a standardized bleeding index during orthodontic treatment.
Measured: Baseline, 1,3to and 6 months
Salivary pH
Salivary pH measured using pH indicator strips during orthodontic treatment. pH value
Measured: Baseline, 1,3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 202520 Dec 2026

First posted8 Jan 2026
Study start20 Nov 2025
Primary completion20 Nov 2026 (estimated)
Study completion20 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Prevention of White Spot Lesions in Patients Undergoing Orthodontic TreatmentStudies of the same condition, open and under way.
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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 75 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07325643
Sponsor's protocol ID: WLS-HA-Ortho-2025
Status last verified: Dec 2025
First submitted: 9 Dec 2025
Last updated: 8 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data (IPD) will not be shared outside the study team due to privacy concerns and the sensitive nature of patient information

Publications

Farook, F.F., 2023. The efficacy of manual toothbrushes in patients with fixed orthodontic appliances: a randomized clinical trial. BMC Oral Health, 23(1), p.35 Gorelick, L., Geiger, A.M. & Gwinnett, A.J., 1982. Incidence of white spot formation after bonding and banding. Am J Orthod, 81(2), pp.93-98 Banks, P. & Richmond, S., 1994. Enamel sealants: a clinical evaluation of their value during fixed appliance therapy. Eur J Orthod, 16(1), pp.19-25 Silness, J. & Löe, H., 1964. Periodontal disease in pregnancy. II. Correlation between oral hygiene and periodontal condition. Acta Odontol Scand, 22(1), pp.121-135 Löe, H. & Silness, J., 1963. Periodontal disease in pregnancy. I. Prevalence and severity. Acta Odontol Scand, 21(6), pp.533-551 Du, M., Cheng, N., Tai, B., Jiang, H., Li, J. & Bian, Z., 2011. Randomized controlled trial on fluoride varnish application for treatment of white spot lesion after fixed orthodontic treatment. Clin Oral Investig, 16(2), pp.463-468. https://doi.org/10.1007/s00784-011-0520-4 Gohar, R.A.A.E.G., Ibrahim, S.H. & Safwat, O.M., 2023. Evaluation of the remineralizing effect of biomimetic self-assembling peptides in post-orthodontic white spot lesions compared to fluoride-based delivery systems: randomized controlled trial. Clin Oral Investig, 27(2), pp.613-624. doi:10.1007/s00784-022-04757-7 Campus, G., Cocco, F., Wierichs, R.J., Wolf, T.G., Salerno, C., Arghittu, A., Dettori, M. & Cagetti, M.G., 2024. Effects of Hydroxyapatite-Containing Toothpastes on Some Caries-Related Variables: A Randomised Clinical Trial. Int Dent J, 74(6), pp.754-761. https://doi.org/10.1016/j.identj.2024.01.028 Alkarad, L., Alkhouli, M. & Dashash, M., 2023. Remineralization of teeth with casein phosphopeptide-amorphous calcium phosphate: analysis of salivary pH and the rate of salivary flow. BDJ Open, 9(1), p.16. doi:10.1038/s41405-023-00141-z
Paszyńska, E., Górska, R., Kaczmarek, U., et al., 2023. Caries-preventing effect of a hydroxyapatite-toothpaste in adults: A randomized, double-blind, clinical trial. Frontiers in Public Health, 11, p.1199728. https://doi.org/10.3389/fpubh.2023.1199728 BMC Oral Health, 2022. Effects of hydroxyapatite toothpaste on tooth whitening and enamel remineralization: Clinical evaluation. BMC Oral Health, 22, p.345. https://doi.org/10.1186/s12903-022-02266-3 Saliasi, I., Llodra, J.C., Bravo, M., Tramini, P., Dussart, C., Viennot, S. & Carrouel, F., 2018. Effect of a Toothpaste/Mouthwash Containing Carica papaya Leaf Extract on Interdental Gingival Bleeding: A Randomized Controlled Trial. Int J Environ Res Public Health, 15(12), p.2660. https://doi.org/10.3390/ijerph15122660 Araujo, M.W.B., Charles, C.A., Weinstein, R.B., Parikh-Das, A.M., Zhang, J., & Gunsolley, J.C., 2015. Meta-analysis of the effect of an essential oil-containing mouthrinse on gingivitis and plaque. J Am Dent Assoc, 146(8), pp.610-622. https://doi.org/10.1016/j.adaj.2015.05.007 Hoffman, D.A., Clark, A.E., Rody Jr., W.J., McGorray, S.P. & Wheeler, T.T., 2015. A prospective randomized clinical trial into the capacity of a toothpaste containing NovaMin to prevent white spot lesions and gingivitis during orthodontic treatment. Progress in Orthodontics, 16:25
Kouskoura, T., Ochsner, T., Verna, C., Pandis, N. & Kanavakis, G., 2022. The effect of orthodontic treatment on facial attractiveness: a systematic review and meta-analysis. European Journal of Orthodontics, 44(6), pp.636-649. doi:10.1093/ejo/cjat064 Kozak, U., Lasota, A. & Chałas, R., 2021. Changes in distribution of dental biofilm after insertion of fixed orthodontic appliances. Journal of Clinical Medicine, 10(23), p.5638. doi:10.3390/jcm10235638 Lopes, P.C. et al., 2024. White Spot Lesions: Diagnosis and Treatment - A Systematic Review. BMC Oral Health, 24(1), pp.1-10. doi:10.1186/s12903-023-03720-6 Choi, A.L., Sun, G., Zhang, Y. & Grandjean, P., 2012. Developmental fluoride neurotoxicity: a systematic review and meta-analysis. Environmental Health Perspectives, 120(10), pp.1362-1368. doi:10.1289/ehp.1104912 Amaechi, B.T., AbdulAzees, P.A., Alshareif, D.O., Shehata, M.A., Lima, P.P.C.S., Abdollahi, A., Samadi Kalkhorani, P. & Evans, V., 2019. Comparative efficacy of a hydroxyapatite and a fluoride toothpaste for prevention and remineralization of dental caries in children. BDJ Open, 5:18

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of a Hydroxyapatite-Containing Toothpaste Versus Mouthwash in Preventing White-Spot Lesions During Fixed-Appliance Orthodontic Treatment: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT07325643
Acronym / sponsor ID: WLS-HA-Ortho-2025
Conditions: Prevention of White Spot Lesions in Patients Undergoing Orthodontic Treatment
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 75 participants (estimated)
Lead sponsor: Heba Tahseen AlmasriUniversity, hospital or other
Study start: 20 Nov 2025 (actual)
Primary completion: 20 Nov 2026 (estimated)
Study completion: 20 Dec 2026 (estimated)
First posted: 8 Jan 2026 (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.

This study aims to evaluate the effect of hydroxyapatite-containing toothpaste and mouthwash in preventing white spot lesions in patients undergoing orthodontic treatment.

Participants: 75 patients will be divided into three groups:

Group A: Participants will brush their teeth three times a day using hydroxyapatite toothpaste and rinse twice a day with a placebo mouthwash.
Group B: Participants will brush their teeth three times a day using fluoride toothpaste and rinse twice a day with hydroxyapatite mouthwash.
Group C (Control Group): Participants will brush their teeth three times a day using fluoride toothpaste and rinse twice a day with a placebo mouthwash.

Patients will be followed during their orthodontic treatment to assess the development of white spot lesions.

The study is safe and involves no surgical procedures or risky medications, and will be conducted under the supervision of Principal Investigator Heba Masri after obtaining ethical approval.

Detailed description

Study Design:

Total Participants: 75 patients (25 per group)
Duration: Throughout orthodontic treatment
Groups:
Group A: Brush teeth three times daily with hydroxyapatite toothpaste and rinse twice daily with placebo mouthwash.
Group B: Brush teeth three times daily with fluoride toothpaste and rinse twice daily with hydroxyapatite mouthwash.
Group C (Control): Brush teeth three times daily with fluoride toothpaste and rinse twice daily with placebo mouthwash.

Outcome Assessments:

All assessments of white-spot lesions will be performed using Diagnodent Pen, Gorlick index (GI), digital photographs, Gingival Bleeding Index (GBI), Plaque Index (PI), and salivary pH measurements.

Ethical Considerations:

All participants will sign informed consent prior to joining the study.
The study was approved by the Ethics Committee, College of Dentistry, University of Baghdad.
This study involves low-risk interventions (toothpaste and mouthwash) and does not use U.S. FDA-regulated drugs or devices.

Study Objective:

To determine whether hydroxyapatite-containing toothpaste and/or mouthwash is more effective than conventional products in preventing white spot lesions during orthodontic treatment.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
HAp toothpaste + placebo mouth wash	Experimental	Dietary Supplement: Hydroxyapatite ToothpasteHAp toothpaste + placebo mouthwash * Arm Description: Participants will brush their teeth three times daily with hydroxyapatite toothpaste and rinse twice daily with a placebo mouthwash.
HAp mouthwash + fl toothpaste	Experimental	Dietary Supplement: Hydroxyapatite MouthwashFluoride toothpaste + HAp mouthwash * Arm Description: Participants will brush their teeth three times daily with fluoride toothpaste and rinse twice daily with HAp mouthwash.
Fluoride toothpaste + placebo mouthwash	Placebo comparator	Other: Fluoride Toothpaste + Placebo MouthwashFluoride toothpaste + placebo mouthwash * Arm Description: Participants will brush their teeth three times daily with fluoride toothpaste and rinse twice daily with a placebo mouthwash.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (3 listed)

1. History of previous orthodontic treatment. 2. Bleaching or topical fluoridation within the last six months. 3. Severely rotated any of the study teeth (limiting the appearance of facial surfaces).
4. Visible signs of caries, fluorosis, hypocalcification, or other developmental defects. 5. Restoration on the labial surface of the study teeth. 6. Systemic or endocrine conditions (e.g., cardiac pacemakers, diabetes mellitus).
7. Craniofacial anomalies and clefts.

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
Hydroxyapatite ToothpasteParticipants will brush their teeth three times daily with hydroxyapatite-containing toothpaste to evaluate its effect on preventing white spot lesions during orthodontic treatment.	Dietary supplement	HAp toothpaste + placebo mouth wash
Hydroxyapatite MouthwashParticipants will rinse their mouth twice daily with hydroxyapatite-containing mouthwash to assess its preventive effect on white spot lesions in orthodontic patients.	Dietary supplement	HAp mouthwash + fl toothpaste
Fluoride Toothpaste + Placebo MouthwashParticipants will brush their teeth three times daily with fluoride toothpaste and rinse twice daily with placebo mouthwash, serving as the control group for comparison with hydroxyapatite interventions.	Other	Fluoride toothpaste + placebo mouthwash

Primary outcome

Severity of White Spot Lesions assessed by Gorelick Index
Time frame: Baseline, 1,3 months, and 6 months
Severity of white spot lesions on labial tooth surfaces assessed using the Gorelick index during orthodontic treatment. Time Frame: Baseline to 6 months Unit of Measure: Score
Enamel Demineralization assessed by DIAGNOdent
Time frame: Baseline, 1,3 months, and 6 months
Enamel demineralization level measured using DIAGNOdent laser fluorescence device during orthodontic treatment. Unit of Measure: DIAGNOdent score (laser fluorescence units)

3 secondary outcomes

Plaque Index
Time frame: Baseline, 1, 3 months, 6 months
Gingival Bleeding Index
Time frame: Baseline, 1,3to and 6 months
Salivary pH
Time frame: Baseline, 1,3 and 6 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
BackgroundFarook, F.F., 2023. The efficacy of manual toothbrushes in patients with fixed orthodontic appliances: a randomized clinical trial. BMC Oral Health, 23(1), p.35 Gorelick, L., Geiger, A.M. & Gwinnett, A.J., 1982. Incidence of white spot formation after bonding and banding. Am J Orthod, 81(2), pp.93-98 Banks, P. & Richmond, S., 1994. Enamel sealants: a clinical evaluation of their value during fixed appliance therapy. Eur J Orthod, 16(1), pp.19-25 Silness, J. & Löe, H., 1964. Periodontal disease in pregnancy. II. Correlation between oral hygiene and periodontal condition. Acta Odontol Scand, 22(1), pp.121-135 Löe, H. & Silness, J., 1963. Periodontal disease in pregnancy. I. Prevalence and severity. Acta Odontol Scand, 21(6), pp.533-551 Du, M., Cheng, N., Tai, B., Jiang, H., Li, J. & Bian, Z., 2011. Randomized controlled trial on fluoride varnish application for treatment of white spot lesion after fixed orthodontic treatment. Clin Oral Investig, 16(2), pp.463-468. https://doi.org/10.1007/s00784-011-0520-4 Gohar, R.A.A.E.G., Ibrahim, S.H. & Safwat, O.M., 2023. Evaluation of the remineralizing effect of biomimetic self-assembling peptides in post-orthodontic white spot lesions compared to fluoride-based delivery systems: randomized controlled trial. Clin Oral Investig, 27(2), pp.613-624. doi:10.1007/s00784-022-04757-7 Campus, G., Cocco, F., Wierichs, R.J., Wolf, T.G., Salerno, C., Arghittu, A., Dettori, M. & Cagetti, M.G., 2024. Effects of Hydroxyapatite-Containing Toothpastes on Some Caries-Related Variables: A Randomised Clinical Trial. Int Dent J, 74(6), pp.754-761. https://doi.org/10.1016/j.identj.2024.01.028 Alkarad, L., Alkhouli, M. & Dashash, M., 2023. Remineralization of teeth with casein phosphopeptide-amorphous calcium phosphate: analysis of salivary pH and the rate of salivary flow. BDJ Open, 9(1), p.16. doi:10.1038/s41405-023-00141-z
BackgroundPaszyńska, E., Górska, R., Kaczmarek, U., et al., 2023. Caries-preventing effect of a hydroxyapatite-toothpaste in adults: A randomized, double-blind, clinical trial. Frontiers in Public Health, 11, p.1199728. https://doi.org/10.3389/fpubh.2023.1199728 BMC Oral Health, 2022. Effects of hydroxyapatite toothpaste on tooth whitening and enamel remineralization: Clinical evaluation. BMC Oral Health, 22, p.345. https://doi.org/10.1186/s12903-022-02266-3 Saliasi, I., Llodra, J.C., Bravo, M., Tramini, P., Dussart, C., Viennot, S. & Carrouel, F., 2018. Effect of a Toothpaste/Mouthwash Containing Carica papaya Leaf Extract on Interdental Gingival Bleeding: A Randomized Controlled Trial. Int J Environ Res Public Health, 15(12), p.2660. https://doi.org/10.3390/ijerph15122660 Araujo, M.W.B., Charles, C.A., Weinstein, R.B., Parikh-Das, A.M., Zhang, J., & Gunsolley, J.C., 2015. Meta-analysis of the effect of an essential oil-containing mouthrinse on gingivitis and plaque. J Am Dent Assoc, 146(8), pp.610-622. https://doi.org/10.1016/j.adaj.2015.05.007 Hoffman, D.A., Clark, A.E., Rody Jr., W.J., McGorray, S.P. & Wheeler, T.T., 2015. A prospective randomized clinical trial into the capacity of a toothpaste containing NovaMin to prevent white spot lesions and gingivitis during orthodontic treatment. Progress in Orthodontics, 16:25
BackgroundKouskoura, T., Ochsner, T., Verna, C., Pandis, N. & Kanavakis, G., 2022. The effect of orthodontic treatment on facial attractiveness: a systematic review and meta-analysis. European Journal of Orthodontics, 44(6), pp.636-649. doi:10.1093/ejo/cjat064 Kozak, U., Lasota, A. & Chałas, R., 2021. Changes in distribution of dental biofilm after insertion of fixed orthodontic appliances. Journal of Clinical Medicine, 10(23), p.5638. doi:10.3390/jcm10235638 Lopes, P.C. et al., 2024. White Spot Lesions: Diagnosis and Treatment - A Systematic Review. BMC Oral Health, 24(1), pp.1-10. doi:10.1186/s12903-023-03720-6 Choi, A.L., Sun, G., Zhang, Y. & Grandjean, P., 2012. Developmental fluoride neurotoxicity: a systematic review and meta-analysis. Environmental Health Perspectives, 120(10), pp.1362-1368. doi:10.1289/ehp.1104912 Amaechi, B.T., AbdulAzees, P.A., Alshareif, D.O., Shehata, M.A., Lima, P.P.C.S., Abdollahi, A., Samadi Kalkhorani, P. & Evans, V., 2019. Comparative efficacy of a hydroxyapatite and a fluoride toothpaste for prevention and remineralization of dental caries in children. BDJ Open, 5:18
Systematic review on white spot lesions: diagnosis and treatmentLink provided by the sponsor.
Study on remineralization of teeth with CPP-ACP and salivary pH analysisLink provided by the sponsor.
Randomized clinical trial on hydroxyapatite-containing toothpastes and caries-related variablesLink provided by the sponsor.
Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared outside the study team due to privacy concerns and the sensitive nature of patient information

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.

Heba Tahseen Almasri, BSc, MSc (candidate) contact

009647810440125

heba53104@gmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 0 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 8 Jan 2026. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Heba Tahseen Almasri, BSc, MSc (candidate) (009647810440125, heba53104@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severity of White Spot Lesions assessed by Gorelick Index (time frame: Baseline, 1,3 months, and 6 months). The study lists 2 primary outcomes in all. 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 NCT07325643, which also lists 3 linked publications.

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 8 Jan 2026.