Bone ResorptionNCT04548258
Bone Changes Assessment in Screw-Retained Maxillary Complete Denture With Electric Welded Framework Versus Cast One
A study testing electric intraoral weilding and casting in people with Bone Resorption, run by Cairo University at 1 site in Egypt.
Trial summary
comparing bony changes around implants that will be joined by ametal framework either with electric weiling or with the conventional casting metal Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption
- What is being tested?
- electric intraoral weilding and casting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2020to Nov 2021
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range from 30 to 65 years old.
- Absence of any medical disorder that could complicate the Surgical phase or affect osseointegration.
- The patients must be completely edentulous.
- The patient must have enough bone height for implants minimum length of 10mm and a minimum diameter of 5 mm.
- Patients with good oral hygiene.
- Complete denture wearer.
- Adequate inter arch space for screw retained prosthesis.
- Absence of any intra-oral pathological condition.
Who cannot join
- Patients with recent extraction(less than three months).
- Patients with inflamed ridge or candida infection.
- Patients with flappyridge.
- Parafunctional habits.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University ,Faculty of Dentistry
Cairo, 11553
faculty of dentistry cairo dentistry
cairo university faculty of dentistry
About this study
Official title: Bone Changes Assessment in Screw-Retained Maxillary Implant Supported Complete Denture With Electric Welded Metal Framework Versus Cast One (Randomized Control,Split Mouth Trial)
comparing bony changes around implants that will be joined by ametal framework either with electric weiling or with the conventional casting metal
Read the detailed description
joining multiple implants together in the edentulous arches is considered agood solution, using the conventional casting technique has many disadvantages due to lab errors and time and cost consuming on ,the other hand the study aims to owercome these disadvantages using electric welding metal framework.
- Conditions
- Bone Resorption
- Being tested
- electric intraoral weilding, casting
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electric intraoral weildingDevice
weilding metal framework to the implants in completely edentulous maxilla using electric weilding device intraorally
castingDevice
casting metal framework
| Study group | Role | What they receive |
|---|---|---|
| electric welded metal framework | Experimental | using electric welding device to intraorally join metal framework where the study aim to save time and cost and eliminate lab errors Receives: Device: electric intraoral weilding |
| conventional cast metal technique | Experimental | using the conventional casting technique to join metal framework and compare it with the electric welding technique Receives: Device: casting |
What is being measured
The primary outcome is the main question the study is designed to answer.
bony changes assessment
assessment of bone height changes around implants using digital periapical paralling imaging technique and the unit will be meagured in mm.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study startOct 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone ResorptionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Magdy Abd Elhakm Mohmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548258
- Sponsor's protocol ID
- 6420
- Status last verified
- Oct 2020
- First submitted
- 28 Aug 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Changes Assessment in Screw-Retained Maxillary Implant Supported Complete Denture With Electric Welded Metal Framework Versus Cast One (Randomized Control,Split Mouth Trial)
- ClinicalTrials.gov ID
- NCT04548258
- Acronym / sponsor ID
- 6420
- Conditions
- Bone Resorption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 14 Sep 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.
comparing bony changes around implants that will be joined by ametal framework either with electric weiling or with the conventional casting metal
Detailed description
joining multiple implants together in the edentulous arches is considered agood solution, using the conventional casting technique has many disadvantages due to lab errors and time and cost consuming on ,the other hand the study aims to owercome these disadvantages using electric welding metal framework.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electric welded metal framework | Experimental | Device: electric intraoral weildingusing electric welding device to intraorally join metal framework where the study aim to save time and cost and eliminate lab errors |
| conventional cast metal technique | Experimental | Device: castingusing the conventional casting technique to join metal framework and compare it with the electric welding technique |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age range from 30 to 65 years old.
- Absence of any medical disorder that could complicate the Surgical phase or affect osseointegration.
- The patients must be completely edentulous.
- The patient must have enough bone height for implants minimum length of 10mm and a minimum diameter of 5 mm.
- Patients with good oral hygiene.
Key exclusion criteria (4 listed)
- Patients with recent extraction(less than three months).
- Patients with inflamed ridge or candida infection.
- Patients with flappyridge.
- Parafunctional habits.
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 |
|---|---|---|
| electric intraoral weildingweilding metal framework to the implants in completely edentulous maxilla using electric weilding device intraorally | Device | electric welded metal framework |
| castingcasting metal framework | Device | conventional cast metal technique |
Primary outcome
bony changes assessment
Time frame: 12 months
assessment of bone height changes around implants using digital periapical paralling imaging technique and the unit will be meagured in mm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electric intraoral weilding and casting in people with Bone Resorption, 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 8 inclusion and 4 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 6 Oct 2020. 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 faculty of dentistry cairo university (0235676105 ext. +2, dentmail@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bony changes assessment (time frame: 12 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 6 Oct 2020.