Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT04390256
Eligibility Criteria:
Inclusion Criteria:
* 1\. Criteria related to patient:
* Age's eligible for trial was 18- 30 years.
* Patient able to read and sign the informed consent form.
* Cooperative patient who are willing to participate and able to continue the schedule time of wok keep good oral hygiene throughout the study.
* Healthy volunteers.
* Patient with moderate and high caries index. 2. Criteria related to tooth:
* Patient with at least 2 white lesions (WSL) detected clinically on the buccal surface of permanent anterior teeth, one on each side. WSL selected either due to caries or orthodontic treatment (just following deboning).
* Teeth with score1, 2, 3 according to ICDAS II.
* Absence of preoperative pain, no mobility \& tenderness on percussion.
* Radiographically, the pre-operative inclusion criteria were absence of internal or external resorption, no periapical radiolucencies and no widening of periodontal ligament space..
Exclusion Criteria:
* 1\. Criteria related to patient:
* Patient with Rampant uncontrolled caries.
* Patient with compromised medical history.
* Pregnant or breast feeding females.
* Heavy smoker.
* Patient who currently received extensive fluoride regiments for treatment of WSL.
* Patients who planned to move within 3 months of enrollment.
* Patient with evidence of xerostomia. 2. Criteria related to tooth:
* Teeth with score 4, 5 according to ICDAS II.
* Teeth with periapical pathology, internal or external resorption or exhibiting any symptoms of pulp pathology.
* Teeth with questionable vitality or have root canal therapy.
* Teeth have been pulp capped.
* Teeth with periodontal pocket and bleeding on probing.
* Cracked teeth.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT04390256
Study Brief:
Protocol Section:
NCT04390256