Patient SatisfactionNCT04722744
Marginal Bone Changes of CAD/CAM Implant Supported Screw-retained and Screw-mented Metal Frameworks
A study testing screwmented metal frameworks in people with Patient Satisfaction and Bone Loss, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction, Bone Loss
- What is being tested?
- screwmented metal frameworks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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%).
Trial locations and contacts
1 site in 1 country.
Iman Radi, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Cairo, Manial, 11555
Amr Magdy, Masters, amr.magdy@dentistry.cu.edu.eg
Iman AW Radi, PhD, iman.abdelwahab@dentistry.cu.edu.eg
About this study
Official title: Marginal Bone Changes of CAD/CAM Implant Supported Screw-retained Metal Frameworks Based on Actual Versus Screwmented Ones Based on Virtual Implant Position: A Randomized Clinical Stud
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.
Read the detailed description
patients with at least three missing teeth will be recruited and randomly assigned into two parallel groups. both groups will receive three implants based on planned implant positions and then one group will receive screw retained CAD CAM restoration with conventional impression technique while the second group will receive screw-mented CAD CAM restoration based on planned implant positions.
- Conditions
- Patient Satisfaction, Bone Loss
- Being tested
- screwmented metal frameworks
- Medical subject headings
- Patient Satisfaction, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screwmented metal frameworksProcedure or surgery
Intervention group: in which the edentulous area will be restored with 3-implant, screwmented CAD/CAM frameworks constructed based on planned implant positions
| Study group | Role | What they receive |
|---|---|---|
| screwmented metal frameworks based on virtual implant position. | Experimental | this group will receive a CAD CAM restoration based on virtually planned implant position. Receives: Procedure: screwmented metal frameworks |
| screw-retained metal frameworks based on actual implant position. | Active comparator | this group will receive screw retained CAD CAM restoration based on actual implant position using conventional open tray impression. Receives: Procedure: screwmented metal frameworks |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal bone changes.
Using long cone paralleling technique , RINN XCP and Digora (digital periapical radiographs for standardization. the bone loss is measured in mm
Measured: 6 months
Secondary outcomes (1)
Patient satisfaction
Patient satisfaction questionnaire using Visual Analogue Scale (VAS) scale, from 0-100, where 0 is the worst meaning that patient is not satisfied and 100 is the highest satisfaction meaning the patient is totally satisfied
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Mar 2022
- Primary completionMay 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Magdy Ibrahim, Cairo University
- Investigators
- Azza Hussein, PhD, Study chair, Professor of ProsthodonticsMohamed ElKhashab, PhD, Study director, Lecturer of prosthodonticsIman Radi, PhD, Study director, Professor of Prosthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722744
- Sponsor's protocol ID
- 101120
- Status last verified
- Mar 2022
- First submitted
- 20 Jan 2021
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marginal Bone Changes of CAD/CAM Implant Supported Screw-retained Metal Frameworks Based on Actual Versus Screwmented Ones Based on Virtual Implant Position: A Randomized Clinical Stud
- ClinicalTrials.gov ID
- NCT04722744
- Acronym / sponsor ID
- 101120
- Conditions
- Patient Satisfaction, Bone Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
patients with at least three missing teeth will be recruited and randomly assigned into two parallel groups. both groups will receive three implants based on planned implant positions and then one group will receive screw retained CAD CAM restoration with conventional impression technique while the second group will receive screw-mented CAD CAM restoration based on planned implant positions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| screwmented metal frameworks based on virtual implant position. | Experimental | Procedure: screwmented metal frameworksthis group will receive a CAD CAM restoration based on virtually planned implant position. |
| screw-retained metal frameworks based on actual implant position. | Active comparator | Procedure: screwmented metal frameworksthis group will receive screw retained CAD CAM restoration based on actual implant position using conventional open tray impression. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| screwmented metal frameworksIntervention group: in which the edentulous area will be restored with 3-implant, screwmented CAD/CAM frameworks constructed based on planned implant positions | Procedure or surgery | screw-retained metal frameworks based on actual implant position., screwmented metal frameworks based on virtual implant position. |
Primary outcome
marginal bone changes.
Time frame: 6 months
Using long cone paralleling technique , RINN XCP and Digora (digital periapical radiographs for standardization. the bone loss is measured in mm
1 secondary outcome
Patient satisfaction
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iman Radi, PhD contact
Azza Hussein, PhD study chair
Professor of Prosthodontics
Mohamed ElKhashab, PhD study director
Lecturer of prosthodontics
Iman Radi, PhD study director
Professor of Prosthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing screwmented metal frameworks in people with Patient Satisfaction and Bone Loss, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr Magdy, Masters (00201285247060, amr.magdy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
marginal bone changes. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.