Implant ComplicationNCT05297253
Prosthetic and Biological Complications of Implant Supported Prostheses
An observational study of Implant Complication, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
complications of implant retained prostheses Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Implant Complication
- What is being tested?
- telescopic overdenture
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2022to 30 Dec 2022
- Phase
- Observational
- 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
Study population: completely edentulous patients
Who may be able to join
- completely edentulous patients
Who cannot join
- medically free adequate bone quality and quantity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prosthetic and Biological Complications of Implant Retained Fixed Versus Removable Telescopic Overdentures
complications of implant retained prostheses
Read the detailed description
counting and analyzing the prosthetic and biological complications of the fixed and removable implant retained prostheses in the completely edentulous patients
- Conditions
- Implant Complication
- Being tested
- telescopic overdenture
- Keywords
- dental implant prosthesis, completely edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telescopic overdentureDevice
Also called fixed implant prosthses
fixed implant retained prostheses
| Study group | Role | What they receive |
|---|---|---|
| telescopic overdenture group | patients receiving implant retained telescopic overdentures | |
| fixed group | patients receiving fixed implant prostheses Receives: Device: telescopic overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
biological complications
biological complications of implant retained prostheses
Measured: one month
Secondary outcomes (1)
prosthetic complications
prosthetic complications of implant retained prostheses
Measured: three months after delivery of the prostheses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start20 Mar 2022
- Primary completion19 Oct 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant ComplicationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Gamal Helal, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297253
- Sponsor's protocol ID
- 20199
- Status last verified
- May 2024
- First submitted
- 17 Mar 2022
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic and Biological Complications of Implant Retained Fixed Versus Removable Telescopic Overdentures
- ClinicalTrials.gov ID
- NCT05297253
- Acronym / sponsor ID
- 20199
- Conditions
- Implant Complication
- Keywords
- dental implant prosthesis, completely edentulous
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 28 Mar 2022 (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.
complications of implant retained prostheses
Detailed description
counting and analyzing the prosthetic and biological complications of the fixed and removable implant retained prostheses in the completely edentulous patients
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telescopic overdenture group | – | –patients receiving implant retained telescopic overdentures |
| fixed group | – | Device: telescopic overdenturepatients receiving fixed implant prostheses |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- completely edentulous patients
Key inclusion criteria (1 listed)
- completely edentulous patients
Key exclusion criteria (1 listed)
- medically free adequate bone quality and quantity
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 |
|---|---|---|
| telescopic overdentureAlso: fixed implant prosthsesfixed implant retained prostheses | Device | fixed group |
Primary outcome
biological complications
Time frame: one month
biological complications of implant retained prostheses
1 secondary outcome
prosthetic complications
Time frame: three months after delivery of the prostheses
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implant Complication, run by National Research Centre, Egypt 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biological complications (time frame: one month). 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 30 May 2024.