Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580483
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Assessment of Two Filling Materials for Teeth-tissue Supported Overdenture
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Assessment of Two Filling Materials As Restorative Options for Tooth-tissue Supported Overdenture a Split-mouth Randomized Trial
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Methods 28 patients with bilateral remaining first premolar in the maxillary or mandibular arch were enrolled in the study Dome shaped preparations of the abutments were performed The amalgam and composite restorations were randomly assigned to either the right or left remaining premolar then conventional steps of overdenture fabrication and insertion were accomplished Patients were followed up for 3 years
Detailed Description:
For all cases root planning and supra- and subgingival scaling were carried out utilizing an ultrasonic scaler For all cases all teeth were cleaned shaped and obturated during the patients first visit Local anaesthesia was achieved by local infiltration After anaesthesia an endodontic access cavity was established Canals were prepared using the crowndown technique The ideal working length was determined using an electronic apex locator and periapical radiographs The canals were cleaned and shaped The final instrumentation size was determined as three sizes larger than the first file binding at the working length Master apical files ranged from 25 to 50 depending on both root anatomy and initial diameter of the root canalIrrigation was always performed with 525 NaOCl solution Obturation using gutta-percha The master gutta-percha cone was coated with AH Plus obturation was carried out utilizing the lateral compaction technique Afterwards selective etching of enamel for 30 seconds then rinsing and dryness were done followed by application of universal bonding agent with agitation action which was then light cured for 20 seconds It was then followed by core buildup with light cured Nano-filled composite body As for the amalgam high-copper non-gamma 2 spherical and lathe cut amalgam was used For all patients fabrication of new dentures was employed
Data were statistically described in terms of mean standard deviation SD 95 CI median and range Data were tested for the normal assumption using Kolmogorov Smirnov test Comparison between the study groups was done using Student t test for independent samples Two-sided p values less than 005 was considered statistically significant IBM SPSS Survival analysis was done using Kaplan Maier statistics
Data were statistically described in terms of mean standard deviation SD 95 CI median and range Data were tested for the normal assumption using Kolmogorov Smirnov test Comparison between the study groups was done using Student t test for independent samples Two-sided p values less than 005 was considered statistically significant IBM SPSS Survival analysis was done using Kaplan Maier statistics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None