Hydroxyapatite toothpaste and mouthwash to prevent white spot lesions during orthodontic treatment

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

This test will see if using hydroxyapatite toothpaste or mouthwash can prevent white spot lesions in people wearing braces.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sex: All
• Sponsor: University of Baghdad (other)
• Locations: 1 site (Baghdad)
• Trial ID: NCT07325643 on ClinicalTrials.gov

What this trial studies

This randomized three-group study will enroll 75 orthodontic patients without existing white spot lesions and follow them throughout their fixed-appliance treatment. Participants will be assigned to hydroxyapatite toothpaste with placebo rinse, fluoride toothpaste with hydroxyapatite rinse, or fluoride toothpaste with placebo rinse. Outcomes include Diagnodent Pen readings, Gorlick index, digital photos, gingival bleeding and plaque indices, and salivary pH measured over the course of treatment. The interventions are low-risk topical products and the study is conducted at the University of Baghdad College of Dentistry under ethical approval.

Who should consider this trial

Good fit: Ideal candidates are patients beginning comprehensive fixed-appliance orthodontic treatment with full permanent dentition, good oral hygiene, normal salivary flow and buffer capacity, and no existing white spot lesions.

Not a fit: Patients who already have white spot lesions, poor oral hygiene, recent bleaching or topical fluoridation, significant dental restorations on the study teeth, or certain systemic conditions are unlikely to benefit from this prevention-focused intervention.

Why it matters

Potential benefit: If successful, hydroxyapatite products could reduce the new development of white spot lesions around orthodontic brackets and help preserve tooth enamel and appearance.

How similar studies have performed: Previous research has shown hydroxyapatite can help remineralize enamel and reduce sensitivity, but evidence specifically for preventing white spot lesions during orthodontic treatment is limited and mixed.

Eligibility 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.

Where this trial is running

Baghdad

• University of Baghdad - College of Dentistry / Orthodontic Clinic — Baghdad, Iraq (RECRUITING)

Study contacts

• Study coordinator: Heba Tahseen Almasri, BSc, MSc (candidate)

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