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NCT Number: NCT07325643

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Baghdad - College of Dentistry / Orthodontic Clinic

Baghdad, Iraq

Location status: Recruiting

Location contact

Heba Tahseen Almasri, BSc, MSc (candidate)

CONTACT

[email protected]

009647810440125

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).
  • 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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. Plaque Index

    Time frame: Baseline, 1, 3 months, 6 months

    Plaque accumulation assessed using a standardized plaque index during orthodontic treatment.

  2. Gingival Bleeding Index

    Time frame: Baseline, 1,3to and 6 months

    Gingival bleeding assessed using a standardized bleeding index during orthodontic treatment.

  3. Salivary pH

    Time frame: Baseline, 1,3 and 6 months

    Salivary pH measured using pH indicator strips during orthodontic treatment. pH value

Study contacts

Contact information is provided by the study sponsor or research team.

Heba Tahseen Almasri, BSc, MSc (candidate)

CONTACT

[email protected]

009647810440125

Sponsors and collaborators

Lead sponsor

Heba Tahseen Almasri

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.