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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-20

Study Completion Date

2026-12-20

Brief Summary

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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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Detailed Description

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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

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Prevention of White Spot Lesions in Patients Undergoing Orthodontic Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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HAp toothpaste + placebo mouth wash

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.

Group Type EXPERIMENTAL

Hydroxyapatite Toothpaste

Intervention Type 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 mouthwash + fl toothpaste

Fluoride toothpaste + HAp mouthwash

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

Group Type EXPERIMENTAL

Hydroxyapatite Mouthwash

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Fluoride Toothpaste + Placebo Mouthwash

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes