3D -Printed Single Implant Overdentures
3D Printing/Additive Manufacturing of Single- Implant Overdentures. A Randomized Controlled Clinical Trial.
1 other identifier
interventional
28
1 country
1
Brief Summary
A randomized clinical trial (RCT) was designed. The participants were randomly allocated into either of the two groups intervention or control group each of 14 participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.
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 Jan 2021
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
First Submitted
Initial submission to the registry
April 21, 2020
CompletedFirst Posted
Study publicly available on registry
April 29, 2020
CompletedStudy Start
First participant enrolled
January 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2022
CompletedNovember 9, 2022
November 1, 2022
1.4 years
April 21, 2020
November 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Implant survival
The implants were considered surviving if they were clinically stable, functioning without any mobility
1 year
Secondary Outcomes (2)
Survival rate of overdentures
1 year
maximum biting force (MBF)
1 year
Study Arms (2)
control
EXPERIMENTALParticipants in control group (Group-A) received conventional manufactured implant overdenture
intervention
EXPERIMENTALparticipants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.
Interventions
Eligibility Criteria
You may qualify if:
- the participant should be completely edentulous ranging in age from 35 to 75 years
- Angle's class I skeletal relationship
- normal facial symmetry
- adequate inter-arch space not less than 12mm
- should be a cooperative patient -
You may not qualify if:
- temporomandibular disorders
- uncontrolled diabetes
- bleeding disorders or anticoagulant therapy
- flabby tissues or sharp mandibular residual ridge
- neuromuscular disorders
- Angle's class II and III skeletal relationship.
- Patients who were heavy smokers
- chemotherapy or radiotherapy or with severe psychiatric disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Msa Uni
Giza, 12451, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dina Elawady, PHD
Lecturer
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of Prosthodontics (principal investigator)
Study Record Dates
First Submitted
April 21, 2020
First Posted
April 29, 2020
Study Start
January 20, 2021
Primary Completion
June 20, 2022
Study Completion
August 21, 2022
Last Updated
November 9, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share