Comparison of Two GIC's in the Restoration of Posterior Class II Lesions in the Primary Dentition (NCT05965297) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of Two GIC's in the Restoration of Posterior Class II Lesions in the Primary Dentition
Brazil, Portugal140 participantsStarted 2023-08
Plain-language summary
This study will investigate the clinical performance of a novel restorative glass ionomer (DeltaFil, DMG) in comparison to an established restorative glass ionomer (Riva Self Cure HV, SDI) in the restoration of Class II cavities in primary molars.
Who can participate
Age range
4 Years – 8 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:
* At least 1 and up to 3 primary molars with either International Caries Detection and Assessment System (ICDAS) lesions stage 2-5 or preexisting restorations requiring placement/replacement of Class II restorations
* Defects limited to occlusal-proximal surface, with cavity sizes smaller than 3 mm mesio-distally and 3 mm in the occluso-cervical and bucco-lingual directions measured with a World Health Organization (WHO)-graded periodontal probe
* Teeth should have both adjoining and their antagonist teeth present. After restoration the restored tooth should enable appropriate proximal contacts on both mesial and distal surfaces after setting of the class II restoration and be in occlusion with the antagonist tooth
* Good access
* Good general health (ASA I, II)
* Good oral hygiene (OHI-S \< 1.9)
* Guardians have given informed consent
* Child is cooperative and assented
Exclusion Criteria:
* Known allergy/ sensitivity to GIC or other materials used in this study
* Space maintainers or orthodontic appliances
* Tooth has a caries lesion or restoration other than those included in the study
* Tooth has pathological mobility
* Tooth has preexisting developmental defects
* Tooth with pulp exposure or indication for endodontic treatment
* Pain, fistula or abscess related to the selected tooth
* Obvious signs of parafunctional habits (e.g. bruxism)
* Participation in another study
* Incapable to participate in the recall visits at the university hospital
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.