University of Baghdad - College of Dentistry / Orthodontic Clinic
Baghdad, Iraq
Location status: Recruiting
NCT Number: NCT07325643
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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Interventional
Not applicable
Baghdad, Iraq
Location status: Recruiting
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:
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:
Study Objective:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All included participants will be drawn from those who will receive comprehensive orthodontic treatment and fulfill the following inclusion criteria:
Exclusion criteria
Participants will brush their teeth three times daily with hydroxyapatite-containing toothpaste to evaluate its effect on preventing white spot lesions during orthodontic treatment.
Participants will rinse their mouth twice daily with hydroxyapatite-containing mouthwash to assess its preventive effect on white spot lesions in orthodontic patients.
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.
Time frame: Baseline, 1,3 months, and 6 months
Severity of white spot lesions on labial tooth surfaces assessed using the Gorelick index during orthodontic treatment.
Time Frame:
Baseline to 6 months
Unit of Measure:
Score
Time frame: Baseline, 1,3 months, and 6 months
Enamel demineralization level measured using DIAGNOdent laser fluorescence device during orthodontic treatment.
Unit of Measure:
DIAGNOdent score (laser fluorescence units)
Time frame: Baseline, 1, 3 months, 6 months
Plaque accumulation assessed using a standardized plaque index during orthodontic treatment.
Time frame: Baseline, 1,3to and 6 months
Gingival bleeding assessed using a standardized bleeding index during orthodontic treatment.
Time frame: Baseline, 1,3 and 6 months
Salivary pH measured using pH indicator strips during orthodontic treatment. pH value
Contact information is provided by the study sponsor or research team.
Heba Tahseen Almasri
Other
Effectiveness of a Hydroxyapatite-Containing Toothpaste Versus Mouthwash in Preventing White-Spot Lesions During Fixed-Appliance Orthodontic Treatment: A Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.