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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Baghdad - College of Dentistry / Orthodontic Clinic
  Baghdad, Iraq Recruiting

Study contacts

• Study coordinator: Heba Tahseen Almasri, BSc, MSc (candidate)
• Email: heba53104@gmail.com
• Phone: 009647810440125

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.