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:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT04112706
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients between the age of 18 and 50 years who were capable of providing informed consent. Subjects older than 50 were not included in the study because of more secondary dentine present less chances of developing sensitivity.
* Subject who had anterior tooth discoloration (equivalent to or darker than Vita shade A3).
* Subjects who were available for a potential recall period of one year.
* Subjects who had no severe systemic disorders. Subjects who needed antibiotics for prevention of spontaneous bacterial endocarditis (SBE) or artificial joints were included.
Exclusion Criteria:
* Subjects who had any known allergies to any materials used in this protocol.
* Patients with milk protein allergies since one of the materials used is derived from milk protein.
* Pregnant women were excluded from the study due to lack of available data for the safety of the bleaching gel for pregnant women.
* Subjects involved in other clinical trials utilizing a similar protocol.
* Subject who had used any dentist-supplied or over the counter vital tooth bleaching product in the previous six months.
* The subjects who have used any desensitizing agents including toothpaste in the past six months.
* Subjects who took COX-2 NSAIDs on daily basis or were under medical treatment at that time for major psychiatric illness that may have altered the perception of pain/discomfort and/or inhibit the subject from completing the study.
* Subjects who had any periodontal surgery or scaling performed in the past six months.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04112706
Study Brief:
Protocol Section:
NCT04112706