Periodontal Biocompatibility of Pediatric Crowns (NCT07611292) | Clinical Trial Compass
CompletedNot Applicable
Periodontal Biocompatibility of Pediatric Crowns
Turkey (Türkiye)21 participantsStarted 2024-06-30
Plain-language summary
Different full-coverage crown materials are widely used in pediatric dentistry for the restoration of primary teeth with extensive substance loss. Since these restorations remain in close contact with gingival tissues for prolonged periods, they may influence periodontal health depending on their surface characteristics, marginal adaptation, and biological properties. The aim of this study was to evaluate the effects of stainless steel crowns (SSC), prefabricated zirconia crowns (PZC), and fiber-glass crowns (FGC) on periodontal health in children using both clinical periodontal parameters and gingival crevicular fluid (GCF) biomarkers, including IL-1β and MMP-8, within a split-mouth study design.
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:
* Children who were aged between 6 and 9 years
* Children had a score of 3 or 4 on the Frankl Behavioral Scale
* Children had an indication for full coronal restoration in the primary second molars in all the three quadrants
* Presence of extensive or chronic carious lesions involving the pulp with radiographic scores ranging between 2 and 3
* Presence of localized hypoplastic defects
* Normal or non-resorbed interproximal bone levels, defined radiographically as a distance of no more than 2 mm between the interdental bone crest and the cementoenamel junction
* Those where the root resorption level was blunt or the apex was rounded, and those where 1/4 of the root has been resorbed
Exclusion Criteria:
* Children had any systemic disease
* History of allergy to local anesthetic agents, nickel, or resin-based restorative materials
* Extremely poor oral hygiene
* Periodontal disease
* Malocclusion
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
assessment of probing pocket depth (PPD)
Timeframe: From beginning to the end of treatment at 6 months
2
assessment of matrix metalloproteinase-8 (MMP-8) level in gingival crevicular fluid (GCF)
Timeframe: in the sixth month (after sample collection was complete)
3
Assessment of bleeding on probing (BOP)
Timeframe: From beginning to the end of treatment at 6 months
4
Assessment of plaque index (PI)
Timeframe: From beginning to the end of treatment at 6 months
5
Assessment of Gingival index (GI)
Timeframe: From beginning to the end of treatment at 6 months
6
Assessment of interleukin-1 beta (IL-1β) level in gingival crevicular fluid (GCF)
Timeframe: in the sixth month (after sample collection was complete)
Trial details
NCT IDNCT07611292
SponsorRecep Tayyip Erdogan University Training and Research Hospital