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

Heba Tahseen Almasri

Status: Enrolling

Conditions: Prevention of White Spot Lesions in Patients Undergoing Orthodontic Treatment

Treatments: Other: Fluoride Toothpaste + Placebo Mouthwash; Dietary Supplement: Hydroxyapatite Mouthwash; Dietary Supplement: Hydroxyapatite Toothpaste

Study type: Interventional

Funder types: Other

Identifiers

NCT07325643

WLS-HA-Ortho-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

1. Complete permanent dentition up to the first premolar, with no intended extractions in orthodontic treatment plan.
2. Good overall health.
3. Good oral hygiene: full-mouth plaque score < 20%.
4. No bleeding upon probing after 30 seconds.
5. Discontinuous band of plaque at the gingival margin.
6. Normal stimulated salivary flow rate.
7. 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups, including a placebo group

HAp toothpaste + placebo mouth wash

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Hydroxyapatite Toothpaste

HAp mouthwash + fl toothpaste

Experimental group

Description:

Fluoride toothpaste + HAp mouthwash * Arm Description: Participants will brush their teeth three times daily with fluoride toothpaste and rinse twice daily with HAp mouthwash.

Treatment:

Dietary Supplement: Hydroxyapatite Mouthwash

Fluoride toothpaste + placebo mouthwash

Placebo Comparator group

Description:

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.

Treatment:

Other: Fluoride Toothpaste + Placebo Mouthwash