Assessment of Two Filling Materials for Teeth-tissue Supported Overdenture
Comparative Assessment of Two Filling Materials As Restorative Options for Tooth-tissue Supported Overdenture: a Split-mouth Randomized Trial
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2024
CompletedFirst Submitted
Initial submission to the registry
August 29, 2024
CompletedFirst Posted
Study publicly available on registry
August 30, 2024
CompletedAugust 30, 2024
August 1, 2024
3 years
August 29, 2024
August 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Wear depth
For each patient, a scan of the abutments was performed using intra-oral scanner in the day of overdenture insertion and another scan was performed after 36m follow up periods and then both scans are compared
36 months
Survival of the restoration
Restoration survival was assessed according to the criteria approved by the FDI World Dental Federation (FDI) Scientific Committee in 2007 and the General Assembly in 2008 as criteria specifically developed for use in clinical trials.
36 months
Study Arms (2)
A tooth (on one side) supporting complete overdenture
EXPERIMENTALThe tooth is prepared to receive a restoration
A tooth (on the other side) supporting complete overdenture
ACTIVE COMPARATORThe tooth is prepared to receive another restoration
Interventions
An abutment tooth is restored on a side by amalgam plug
An abutment tooth is restored on a side by nano-composite
Eligibility Criteria
You may qualify if:
- Presented with partially edentulous maxillary and mandibular arches particularly with bilaterally remaining any of these teeth ; #33 #34 #35 #43 #44 #45 #13 # 14#15 #23 # 24 #25
- Good periodontal support and grade I mobility.
- They were medically free.
You may not qualify if:
- Medically compromised
- Grade II and grade III mobility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Delta University for Science & Technology
Al Mansurah, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wafaa I Ibrahim
Assoc. Prof.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2024
First Posted
August 30, 2024
Study Start
March 20, 2021
Primary Completion
March 20, 2024
Study Completion
June 15, 2024
Last Updated
August 30, 2024
Record last verified: 2024-08