A Comparative Clinical Study Assessing Dentin Thickness and Discoloration in Deep Carious Lesions… (NCT07358442) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Comparative Clinical Study Assessing Dentin Thickness and Discoloration in Deep Carious Lesions Treated With Biodentine Alone Versus Diode Laser Pre-treatment Followed by Biodentine
Egypt48 participantsStarted 2025-07-30
Plain-language summary
This interventional clinical study aims to compare dentin thickness preservation and tooth discoloration in deep carious lesions treated with Biodentine alone versus diode laser pre-treatment followed by Biodentine. Participants with deep carious lesions will be allocated to one of two treatment protocols, and clinical and radiographic assessments will be performed to evaluate outcomes. The findings of this study may provide evidence on whether diode laser pre-treatment offers additional clinical benefits when used prior to Biodentine application in the management of deep caries.
Who can participate
Age range
18 Years – 45 Years
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
. Patients aged \[ 18-45 years\] requiring treatment for a single deep carious lesion and willing to provide informed consent and comply with follow-up appointments. Candidates with good general health.
. tooth-related criteria included reversible pulpitis or asymptomatic restorable vital permanent posterior molar. (based on clinical and radiographic examination, pulp vitality tests).
. Radiographic evidence of deep caries approaching the pulp (e.g., inner half of dentin).
. No signs of irreversible pulpitis or periapical pathology.
Exclusion criteria
. Patients undergoing orthodontic treatment or with significant periodontal disease affecting the study tooth or who cannot tolerate CBCT scanning.
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.
. patients who are medically compromised (systemic diseases affecting bone metabolism or healing (e.g., uncontrolled diabetes)).
. pregnant ladies, patients with allergy to any component of Biodentine or other materials used, and patients who are not cooperative.
. Tooth-related criteria involved teeth that have irreversible pulpitis or necrotic pulp (based on symptoms and vitality tests; spontaneous pain, or sustained pain after vitality tests (electrical or cold tests), teeth with pain on percussion ).
. Teeth with periapical radiolucency and have been already restored before (previous endodontic treatment)
. Extensive tooth destruction requiring full coronal coverage.