Microbiological Evaluation and Clinical 24-month Follow-up of Adhesive Systems on Carious Dentin (NCT05676671) | Clinical Trial Compass
CompletedNot Applicable
Microbiological Evaluation and Clinical 24-month Follow-up of Adhesive Systems on Carious Dentin
Brazil104 participantsStarted 2010-02
Plain-language summary
The objectives were to evaluate the antibacterial effect of self-etching adhesives on carious dentin and the clinical results of restorations in a randomized controlled clinical trial. 104 carious deciduous molars (n=92) were randomly allocated to receive one of the self-etching adhesives: Clearfil SE Bond - control (CB - n =53) or Clearfil SE Protect containing MDPB (CP - n=51) after caries removal selective. Clinical, radiographic, photographic and plaster model assessments (n=53 deciduous molars, CB=29, CP=24) of resin restorations were performed at baseline and at 6, 12, and 24 months. Dentin samples (n=51 deciduous teeth; CB=24 and CP=27) were collected immediately after excavation of carious dentin and 3 months later, and cultured for mutans streptococci - (MS), lactobacilli (LB) and total microorganisms (TM). Data were statistically analyzed (p\<0.05).
Who can participate
Age range
6 Years – 9 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:
* deciduous molars with one or two surfaces with caries lesions;
* children without systemic problems and who were not using any medication;
* absence of spontaneous pain, edema or fistula, and dental mobility;
* radiographically, caries lesions in the inner half of the dentin thickness, absence of pulp contact with the lesion, absence of internal or external root resorption, and other changes suggestive of degenerative pulp conditions, such as radiolucencies in the furcation or periapical regions or widening of periodontal spaces.
Exclusion Criteria:
* Caries lesions with involvement of the pulp or periodontal tissues;
* Children with systemic problems.
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.
What they're measuring
1
Clinical evaluation of restorations using the USPHS criteria