Alveolar Bone LossNCT06012643
Subperiosteal Implants Constructed With Digital Technology
An observational study of Alveolar Bone Loss, run by Mansoura University at 1 site in Egypt.
Trial summary
Atrophied jaw is a condition where there is insufficient bone quantity to place root form implants. Several treatment plans are available for treating atrophied jaws, including subperiosteal implants. Subperiosteal implants were introduced in the last century. Read more about this study
- Who is it for?
- Ages 15 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- The purpose of this systematic review of case reports and case series was to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology.
- How many people
- 23 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 30 Oct 2023
- 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 15 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: An electronic and manual search was conducted in the PubMed, Scopus, and Google Scholar databases. Publications of case reports and series written in English without data restrictions in the last 5 years.
Who may be able to join
- population with partial or fully edentulous arches, in particular Cawood and Howell class (IV-VI);
Who cannot join
- Articles were excluded if complex reconstructive surgery including bone grafts, barrier membranes, jaw osteotomies, sinus lift, alveolar ridge distraction, and zygomatic implants was recommended for treatment
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mohammed El Sawy
Multiple Locations, 12345
Mohammed E Sawy, PhD, +201061314522, Dr_sawy@windowslive.com
Salah A. Hegazy, PhD, +01227690809, salahhegazy2003@yahoo.com
About this study
Official title: Subperiosteal Implants as a Treatment for Severely Atrophied Jaw in Completely and Partially Edentulous Population: A Systematic Review of Case Reports and Case Series.
Atrophied jaw is a condition where there is insufficient bone quantity to place root form implants. Several treatment plans are available for treating atrophied jaws, including subperiosteal implants. Subperiosteal implants were introduced in the last century. Poor clinical results led those implants to be progressively abandoned. Recently, several Authors suggested a revival of subperiosteal implants as an alternative to regenerative procedures.
Read the detailed description
An electronic and manual search was conducted in the PubMed, Scopus, and Google Scholar databases. Publications of case reports and series written in English without data restrictions that reported on subperiosteal implants management of patients with severely atrophied jaws in completely and partially edentulous population.
The purpose of this systematic review of case reports and case series was to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology.
- Conditions
- Alveolar Bone Loss
- Being tested
- The purpose of this systematic review of case reports and case series was to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology.
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The purpose of this systematic review of case reports and case series was to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology.Other
An electronic and manual search was conducted in the PubMed, Scopus, and Google Scholar databases. Publications of case reports and series written in English without data restrictions
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology.
The outcome was implant success or rejection.
Measured: 5 year retrospective
Secondary outcomes (1)
Biological complications
such as (dehiscence or exposure of the framework)
Measured: 5 year retrospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Jun 2023
- Primary completion20 Oct 2023
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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
- Retrospective
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsawy, Mansoura University
- Investigators
- Mohammed ELSawy, PhD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012643
- Sponsor's protocol ID
- A0107023RP
- Status last verified
- Oct 2023
- First submitted
- 13 Aug 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: just by contacting the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subperiosteal Implants as a Treatment for Severely Atrophied Jaw in Completely and Partially Edentulous Population: A Systematic Review of Case Reports and Case Series.
- ClinicalTrials.gov ID
- NCT06012643
- Acronym / sponsor ID
- A0107023RP
- Conditions
- Alveolar Bone Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 25 Aug 2023 (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.
Atrophied jaw is a condition where there is insufficient bone quantity to place root form implants. Several treatment plans are available for treating atrophied jaws, including subperiosteal implants. Subperiosteal implants were introduced in the last century. Poor clinical results led those implants to be progressively abandoned. Recently, several Authors suggested a revival of subperiosteal implants as an alternative to regenerative procedures.
Detailed description
An electronic and manual search was conducted in the PubMed, Scopus, and Google Scholar databases. Publications of case reports and series written in English without data restrictions that reported on subperiosteal implants management of patients with severely atrophied jaws in completely and partially edentulous population.
The purpose of this systematic review of case reports and case series was to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- An electronic and manual search was conducted in the PubMed, Scopus, and Google Scholar databases. Publications of case reports and series written in English without data restrictions in the last 5 years.
Key inclusion criteria (1 listed)
- population with partial or fully edentulous arches, in particular Cawood and Howell class (IV-VI);
Key exclusion criteria (1 listed)
- Articles were excluded if complex reconstructive surgery including bone grafts, barrier membranes, jaw osteotomies, sinus lift, alveolar ridge distraction, and zygomatic implants was recommended for treatment
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 |
|---|---|---|
| The purpose of this systematic review of case reports and case series was to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology.An electronic and manual search was conducted in the PubMed, Scopus, and Google Scholar databases. Publications of case reports and series written in English without data restrictions | Other | – |
Primary outcome
to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology.
Time frame: 5 year retrospective
The outcome was implant success or rejection.
1 secondary outcome
Biological complications
Time frame: 5 year retrospective
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No. just by contacting the corresponding author
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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.
Mohammed ELSawy, PhD principal investigator
Mansoura University
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 Alveolar Bone Loss, run by Mansoura 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 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. 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 Mohammed ELSawy, PhD (00201061314522, Dr_sawy@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology. (time frame: 5 year retrospective). 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 23 Oct 2023.