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

Official title

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

Overview

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

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.

Interventions

• Dietary supplement Hydroxyapatite Toothpaste
  Participants 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 Hydroxyapatite Mouthwash
  Participants will rinse their mouth twice daily with hydroxyapatite-containing mouthwash to assess its preventive effect on white spot lesions in orthodontic patients.
• Other Fluoride Toothpaste + Placebo Mouthwash
  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.

Primary outcome measures

• Severity of White Spot Lesions assessed by Gorelick Index [Time frame: Baseline, 1,3 months, and 6 months]
• Enamel Demineralization assessed by DIAGNOdent [Time frame: Baseline, 1,3 months, and 6 months]

Secondary outcome measures (3)

• 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]

Eligibility criteria

Inclusion Criteria: All included participants will be drawn from those who will receive comprehensive orthodontic treatment and fulfill the following inclusion criteria:

• 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) -

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

Iraq · 1 center

• University of Baghdad - College of Dentistry / Orthodontic Clinic — Baghdad

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
• 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, 2
• 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 Clini

Identifiers

NCT: NCT07325643 · WLS-HA-Ortho-2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗