Prevention of White Spot Lesions in Patients Undergoing Orthodontic Treatment
Conditions
Brief 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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTHydroxyapatite 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.
DIETARY_SUPPLEMENTHydroxyapatite Mouthwash
Participants will rinse their mouth twice daily with hydroxyapatite-containing mouthwash to assess its preventive effect on white spot lesions in orthodontic patients.
OTHERFluoride 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.
Sponsors
Heba Tahseen Almasri
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of White Spot Lesions assessed by Gorelick Index | 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 |
| Enamel Demineralization assessed by DIAGNOdent | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salivary pH | Baseline, 1,3 and 6 months | Salivary pH measured using pH indicator strips during orthodontic treatment. pH value |
| Plaque Index | Baseline, 1, 3 months, 6 months | Plaque accumulation assessed using a standardized plaque index during orthodontic treatment. |
| Gingival Bleeding Index | Baseline, 1,3to and 6 months | Gingival bleeding assessed using a standardized bleeding index during orthodontic treatment. |
Countries
Iraq
Contacts
Primary ContactHeba Tahseen Almasri, BSc, MSc (candidate)
Outcome results
None listed