Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-24 @ 5:01 PM
NCT ID:
NCT03160950
Brief Summary:
A single arm non-blinded study is planned to evaluate the durability of the crowns fabricated using a novel composite based material, LuxaCrown (DMG, Germany). The durability of these crowns will be assessed for anatomical form, marginal adaptation, color match, marginal discoloration, surface roughness, secondary caries, pulpal compatibility, plaque index and modified papillary bleeding index with intensive follow up for 2 years (at 1 week, 3rd, 6th, 12th, 18th and 24th month), and then a yearly follow-up for additional 3 years (at 36th, 48th and 60th month).
A total of 50 patients will be selected and one tooth per subject will be included. For the purpose of study only the healthy adult patients with age range of 25 - 60 years who would be requiring Single crown restoration in the permanent anterior / posterior teeth, either due to caries, pulpal involvement or trauma, will be selected. Teeth that require endodontic treatment shall be included in the study only after successful endodontic therapy has been completed by an experienced endodontist. For broken teeth, only the teeth with \> 1/2 crown structure remaining or in case of teeth with \<1/2 crown structure fractured that can be restored with conventional post and core will be selected. In general, patients with bruxism, or with severe periodontal disease, mobility grade 2 or 3 shall be excluded from the study.
Study:
NCT03160950
Study Brief:
Protocol Section:
NCT03160950