Marginal Bone Changes of CAD/CAM Implant Supported Screw-retained and Screw-mented Metal Frameworks
1 other identifier
interventional
20
1 country
1
Brief Summary
compare CAD/CAM implant supported screw-retained metal frameworks based on actual versus screw-mented ones based on virtual implant position regarding marginal bone changes.
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 2022
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
January 20, 2021
CompletedFirst Posted
Study publicly available on registry
January 25, 2021
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedMarch 25, 2022
March 1, 2022
1.2 years
January 20, 2021
March 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
marginal bone changes.
Using long cone paralleling technique , RINN XCP and Digora (digital periapical radiographs for standardization. the bone loss is measured in mm
6 months
Secondary Outcomes (1)
Patient satisfaction
6 months
Study Arms (2)
screwmented metal frameworks based on virtual implant position.
EXPERIMENTALthis group will receive a CAD CAM restoration based on virtually planned implant position.
screw-retained metal frameworks based on actual implant position.
ACTIVE COMPARATORthis group will receive screw retained CAD CAM restoration based on actual implant position using conventional open tray impression.
Interventions
Intervention group: in which the edentulous area will be restored with 3-implant, screwmented CAD/CAM frameworks constructed based on planned implant positions
Eligibility Criteria
You may qualify if:
- Kennedy class I, II Or IV cases.
- Opposing completely dentulous, fully or partially restored dentition.
- Good oral hygiene.
- The patient should have bone for implants, minimum bone height 10 mm and minimum bone diameter should be 6 mm.
- Adequate inter arch space for restoration 15mm or more.
- Adult patients age ≥18 years
You may not qualify if:
- any medical disorder that could complicate surgical phase or affect osteointegration. Radiation chemotherapy.
- smokers more than 10/daily.
- Uncooperative patients.
- Patients with Para-functional habits
- Patients with severe periodontal diseases.
- Patients with limited mouth opening.
- Presence of intraoral pathological lesions.
- Diabetic (HbA1c \>7.5%).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry
Cairo, Manial, 11555, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Azza Hussein, PhD
Professor of Prosthodontics
- STUDY DIRECTOR
Mohamed ElKhashab, PhD
Lecturer of prosthodontics
- STUDY DIRECTOR
Iman Radi, PhD
Professor of Prosthodontics
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecturer
Study Record Dates
First Submitted
January 20, 2021
First Posted
January 25, 2021
Study Start
March 1, 2022
Primary Completion
May 1, 2023
Study Completion
June 1, 2023
Last Updated
March 25, 2022
Record last verified: 2022-03