RecruitingNot Applicable

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

Iraq75 participantsStarted 2025-11-20

Plain-language summary

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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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) -

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Severity of White Spot Lesions assessed by Gorelick Index

Timeframe: Baseline, 1,3 months, and 6 months

Enamel Demineralization assessed by DIAGNOdent

Timeframe: Baseline, 1,3 months, and 6 months

Trial details

NCT IDNCT07325643

SponsorHeba Tahseen Almasri

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-20

Contact for this trial

Heba Tahseen Almasri, BSc, MSc (candidate)

009647810440125 heba53104@gmail.com

View on ClinicalTrials.gov More Prevention of White Spot Lesions in Patients Undergoing Orthodontic Treatment trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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) -