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

NCT07325643 | Recruiting

• 1 other identifier: WLS-HA-Ortho-2025
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Prevention of White Spot Lesions in Patients Undergoing Orthodontic Treatment

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  Baseline, 1,3 months, and 6 months

Secondary Outcomes (3)

• Plaque Index

  Baseline, 1, 3 months, 6 months

• Gingival Bleeding Index

  Baseline, 1,3to and 6 months

• Salivary pH

  Baseline, 1,3 and 6 months

Study Arms (3)

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.

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.

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.

Other: Fluoride Toothpaste + Placebo Mouthwash

Interventions

Hydroxyapatite Toothpaste DIETARY_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.

HAp toothpaste + placebo mouth wash

Hydroxyapatite Mouthwash DIETARY_SUPPLEMENT

Participants will rinse their mouth twice daily with hydroxyapatite-containing mouthwash to assess its preventive effect on white spot lesions in orthodontic patients.

HAp mouthwash + fl toothpaste

Fluoride Toothpaste + Placebo Mouthwash OTHER

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.

Fluoride toothpaste + placebo mouthwash

Eligibility Criteria

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

You may qualify if:

• Complete permanent dentition up to the first premolar, with no intended extractions in orthodontic treatment plan.
• Good overall health.
• Good oral hygiene: full-mouth plaque score \< 20%.
• No bleeding upon probing after 30 seconds.
• Discontinuous band of plaque at the gingival margin.
• Normal stimulated salivary flow rate.
• Normal buffer capacity (final pH between 6.0 and 7.0) -

You may not qualify if:

• \. 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).
• \. 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).
• \. Craniofacial anomalies and clefts.

Sponsors & Collaborators

• Heba Tahseen Almasri: lead

Study Sites (1)

University of Baghdad - College of Dentistry / Orthodontic Clinic

Baghdad, Iraq

RECRUITING

Related Publications (3)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

Related Links

• Systematic review on white spot lesions: diagnosis and treatment
• Study on remineralization of teeth with CPP-ACP and salivary pH analysis
• Randomized clinical trial on hydroxyapatite-containing toothpastes and caries-related variables

Central Study Contacts

Heba Tahseen Almasri, BSc, MSc (candidate)

CONTACT

009647810440125; heba53104@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 8, 2026
• Study Start: November 20, 2025
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)