EdentulousNCT04372901
Passive Fit of CAD/CAM Screw-retained Metal Frameworks Versus Screwmented Ones
A study testing Digitally constructed frameworks before implant placement and Digitally constructed frameworks after implant placement in people with Edentulous and Jaw, run by Cairo University at 1 site in Egypt.
Trial summary
CAD/CAM (computer aided design/ computer aided manufacturing) constructed screw retained implant supported frameworks give solutions for the problems arising from the lost wax technique by improving accuracy, adaptation and passive fit of the final restoration. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Edentulous, Jaw
- What is being tested?
- Digitally constructed frameworks before implant placement and Digitally constructed frameworks after implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- May 2021to Apr 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- - . any medical disorder that could complicate surgical phase or affect osteointegration. Radiation chemotherapy.
- ii. smokers more than 10/daily.
- iii. Uncooperative patients.
- iv. Patients with Para-functional habits
- v. Patients with severe periodontal diseases.
- vi. Patients with limited mouth opening.
- vii. Presence of intraoral pathological lesions.
- viii. Diabetic (HbA1c >7.5%)
Trial locations and contacts
1 site in 1 country.
mohamed Elsayyed, BDS contact
About this study
Official title: Passive Fit of CAD/CAM Implant Supported Screw-retained Metal Frameworks Based on Actual Versus Screwmented Ones Based on Virtual Implant Position: A Randomized Clinical Trial
CAD/CAM (computer aided design/ computer aided manufacturing) constructed screw retained implant supported frameworks give solutions for the problems arising from the lost wax technique by improving accuracy, adaptation and passive fit of the final restoration. However, concerns about the passive fit of a pre-implant insertion CAD/CAM constructed framework still exists due to the expected errors in imaging, registration, surgical guide construction, adaptation and hence transferring the planned position intra-orally.
Read the detailed description
- PICO Format: Population: mandibular free end saddle requiring 2 implants. Intervention: Digitally fabricated screw-mented retained metal frameworks constructed before implant placement Control: Digitally fabricated screw retained metal frameworks constructed after implant placement
Outcome:
Outcome Measuring device Measuring unit Passive fit One screw test Binary 13 Screw resistance Binary Radiographic ( digital periapical radiography) Binary III. Methods A) Participants, interventions \& outcomes 9. Study settings: i. The study will be conducted at Department of Oral Implantology, faculty of oral and dental medicine, Cairo University, Egypt. ii. Participants will be selected from the outpatient clinic of implantology department, faculty of oral and dental medicine, Cairo University, Egypt. 10. Eligibility criteria: A-Inclusion criteria: i- Mandibular Kenndy Class I. ii- Opposing completely dentulous, fully or partially restored dentition. iii- Good oral hygiene. iv- The patient should have bone for implants, minimum bone height 10 mm and minimum bone diameter should be 6 mm. v- Adequate inter arch space for restoration 15mm or more. vi- Adult patients age ≥18 years B- Exclusion criteria: i. any medical disorder that could complicate surgical phase or affect osteointegration. Radiation chemotherapy. ii. smokers more than 10/daily. iii. Uncooperative patients. iv. Patients with Para-functional habits v. Patients with severe periodontal diseases. vi. Patients with limited mouth opening. vii. Presence of intraoral pathological lesions. viii. Diabetic (HbA1c >7.5%).
- Conditions
- Edentulous, Jaw
- Being tested
- Digitally constructed frameworks before implant placement, Digitally constructed frameworks after implant placement
- Keywords
- Passive, Fit, Screwmented, CAD/CAM, Frameworks
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitally constructed frameworks before implant placementProcedure 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.
Digitally constructed frameworks after implant placementProcedure or surgery
Control group: edentulous area will be restored with 3-implant conventional screw retained CAD/CAM frameworks constructed after implant placement.
| Study group | Role | What they receive |
|---|---|---|
| digitally constructed frameworks before implant placement | Experimental | Intervention group in which the edentulous area will be restored with 3-implant screwmented CAD/CAM frameworks constructed based on planned implant positions. Receives: Procedure: Digitally constructed frameworks before implant placement |
| digitally constructed frameworks after implant placement | Active comparator | Control group: edentulous area will be restored with 3-implant conventional screw retained CAD/CAM frameworks constructed after implant placement Receives: Procedure: Digitally constructed frameworks after implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive fit
Evaluation of Passive fit between CAD/CAM Implant Supported Screw-retained Metal Frameworks Based on Actual Versus Screwmented Ones Based on Virtual Implant Position using one screw test .
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study startMay 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EdentulousStudies 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
- Model description
- Trial design to be conducted is RCT, split mouth , two arms, and Equivalence frame with 1:1 allocation ratio.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed El-Sayed Mohamed Kamel, Cairo University
- Investigators
- Mohamed El-Sayyed, BDS, Principal investigator, Teaching assistant MIUMohamed ElKhashab, Phd, Study director, Lecturer of prosthodontics, Faculty of Dentistry, Cairo UniverustyIman Radi, Phd, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372901
- Sponsor's protocol ID
- 123987
- Status last verified
- Apr 2021
- First submitted
- 24 Apr 2020
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The author of "study will publish it in an internationally acknowledged journal.
Publications
de Franca DG, Morais MH, das Neves FD, Barbosa GA. Influence of CAD/CAM on the fit accuracy of implant-supported zirconia and cobalt-chromium fixed dental prostheses. J Prosthet Dent. 2015 Jan;113(1):22-8. doi: 10.1016/j.prosdent.2014.07.010. Epub 2014 Sep 30.
PubMed 25277028
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Fit of CAD/CAM Implant Supported Screw-retained Metal Frameworks Based on Actual Versus Screwmented Ones Based on Virtual Implant Position: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04372901
- Acronym / sponsor ID
- 123987
- Conditions
- Edentulous, Jaw
- Keywords
- Passive, Fit, Screwmented, CAD/CAM, Frameworks
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 4 May 2020 (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.
CAD/CAM (computer aided design/ computer aided manufacturing) constructed screw retained implant supported frameworks give solutions for the problems arising from the lost wax technique by improving accuracy, adaptation and passive fit of the final restoration. However, concerns about the passive fit of a pre-implant insertion CAD/CAM constructed framework still exists due to the expected errors in imaging, registration, surgical guide construction, adaptation and hence transferring the planned position intra-orally.
Detailed description
- PICO Format: Population: mandibular free end saddle requiring 2 implants. Intervention: Digitally fabricated screw-mented retained metal frameworks constructed before implant placement Control: Digitally fabricated screw retained metal frameworks constructed after implant placement
Outcome:
Outcome Measuring device Measuring unit Passive fit One screw test Binary 13 Screw resistance Binary Radiographic ( digital periapical radiography) Binary III. Methods A) Participants, interventions \& outcomes 9. Study settings: i. The study will be conducted at Department of Oral Implantology, faculty of oral and dental medicine, Cairo University, Egypt. ii. Participants will be selected from the outpatient clinic of implantology department, faculty of oral and dental medicine, Cairo University, Egypt. 10. Eligibility criteria: A-Inclusion criteria: i- Mandibular Kenndy Class I. ii- Opposing completely dentulous, fully or partially restored dentition. iii- Good oral hygiene. iv- The patient should have bone for implants, minimum bone height 10 mm and minimum bone diameter should be 6 mm. v- Adequate inter arch space for restoration 15mm or more. vi- Adult patients age ≥18 years B- Exclusion criteria: i. any medical disorder that could complicate surgical phase or affect osteointegration. Radiation chemotherapy. ii. smokers more than 10/daily. iii. Uncooperative patients. iv. Patients with Para-functional habits v. Patients with severe periodontal diseases. vi. Patients with limited mouth opening. vii. Presence of intraoral pathological lesions. viii. Diabetic (HbA1c >7.5%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Trial design to be conducted is RCT, split mouth , two arms, and Equivalence frame with 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| digitally constructed frameworks before implant placement | Experimental | Procedure: Digitally constructed frameworks before implant placementIntervention group in which the edentulous area will be restored with 3-implant screwmented CAD/CAM frameworks constructed based on planned implant positions. |
| digitally constructed frameworks after implant placement | Active comparator | Procedure: Digitally constructed frameworks after implant placementControl group: edentulous area will be restored with 3-implant conventional screw retained CAD/CAM frameworks constructed after implant placement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- - . any medical disorder that could complicate surgical phase or affect osteointegration. Radiation chemotherapy.
- ii. smokers more than 10/daily.
- iii. Uncooperative patients.
- iv. Patients with Para-functional habits
- v. 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 |
|---|---|---|
| Digitally constructed frameworks before implant placementIntervention 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 | digitally constructed frameworks before implant placement |
| Digitally constructed frameworks after implant placementControl group: edentulous area will be restored with 3-implant conventional screw retained CAD/CAM frameworks constructed after implant placement. | Procedure or surgery | digitally constructed frameworks after implant placement |
Primary outcome
Passive fit
Time frame: 10 weeks
Evaluation of Passive fit between CAD/CAM Implant Supported Screw-retained Metal Frameworks Based on Actual Versus Screwmented Ones Based on Virtual Implant Position using one screw test .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Background: PubMed 25277028de Franca DG, Morais MH, das Neves FD, Barbosa GA. Influence of CAD/CAM on the fit accuracy of implant-supported zirconia and cobalt-chromium fixed dental prostheses. J Prosthet Dent. 2015 Jan;113(1):22-8. doi: 10.1016/j.prosdent.2014.07.010. Epub 2014 Sep 30.
- Individual participant dataSharing planned: No. The author of "study will publish it in an internationally acknowledged journal.
Related trials for Edentulous
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
Active, not recruiting
Clinical Evaluation of a New Printable Denture Base Material
Edentulous Mouth
Recruiting
Comparison of Conventional and Face Scan in Recording the Vertical Dimension of Completely Edentulous Patients
Edentulous Complete Denture Wearers
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
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.
mohamed Elsayyed, BDS contact
Mohamed El-Sayyed, BDS principal investigator
Teaching assistant MIU
Mohamed ElKhashab, Phd study director
Lecturer of prosthodontics, Faculty of Dentistry, Cairo Univerusty
Iman Radi, Phd study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digitally constructed frameworks before implant placement and Digitally constructed frameworks after implant placement in people with Edentulous and Jaw, 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 0 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 14 Apr 2021. 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 Iman Radi, PhD (01001539613, iman.abdelwahab@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Passive fit (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04372901, which also lists 1 linked publication.
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 14 Apr 2021.