Mandibular FlexureNCT05617274
Digital Assessment of Mandibular Flexure in Full Arch Fixed Restorations
An observational study of Mandibular Flexure and Full Arch Fixed Prosthesis, run by Future University in Egypt at 1 site in Egypt.
Trial summary
Nine patients (five males and four females) were included in this study who had long-term (10-15 years) of long-span rigid mandibular fixed prostheses that may have led to radiographic changes around the supporting teeth. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mandibular Flexure, Full Arch Fixed Prosthesis
- What is being tested?
- Sectioning of the full arch mandibular fixed prosthesis
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2021to 26 Oct 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: All had the entire mandibular natural dentition (6-8 abutments) splinted with a single-unit metal-ceramic (long-span fixed prosthesis). All of them suffered from different negative consequences of their one-piece fixed restorations. The retrospective collection of the patient's data was tabulated and analyzed. Nine patients were included in this study. Five males and four females, with an age range of 50-76 years were enrolled in this study.
Who may be able to join
- full-arch mandibular single fixed prostheses that served for many years (average 12 years) opposed by natural dentition.
- Patients were free from any systemic or debilitating diseases such as bone diseases, diabetes melilites, or blood dyscrasias.
Who cannot join
- patients with healthy fixed full-arch prosthesis
- patients with segmented prosthesis
- patients with systematic debilitating diseases.
- Patients with temporomandibular joint dysfunction, maxillofacial surgeries, or mandibular trauma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Digital Study of Mandibular Flexure in Patients With Long-span Fixed Restorations Supported by Natural Teeth.
Nine patients (five males and four females) were included in this study who had long-term (10-15 years) of long-span rigid mandibular fixed prostheses that may have led to radiographic changes around the supporting teeth. The treatment plans included the removal of the long-span fixed rigid prostheses followed by restoring the patients with segmented implant-supported prostheses. In order to digitally measure the mandibular flexure, reference markers were adhered to the prostheses, and intraoral scans were obtained before and after splitting the preexisting prostheses at the minimum and maximum mouth opening. The distances between the markers were measured, and mandibular flexure was calculated by subtracting the distance between the markers during the maximum mouth opening from the minimum mouth opening. An independent sample T-test was used to compare mandibular flexure before and after splitting the long-span fixed prostheses.
- Conditions
- Mandibular Flexure, Full Arch Fixed Prosthesis
- Being tested
- Sectioning of the full arch mandibular fixed prosthesis
- Keywords
- Mandibular flexure, Prosthesis Failure, Full arch restorations
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sectioning of the full arch mandibular fixed prosthesisProcedure or surgery
The one unit full arch fixed prosthesis is sectioned at the midline into two pieces
| Study group | Role | What they receive |
|---|---|---|
| Mandibular flexure before sectioning of full arch fixed prosthesis | Not described | |
| Mandibular flexure after sectioning of full arch fixed prosthesis | Not described Receives: Procedure: Sectioning of the full arch mandibular fixed prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in mandibular flexure
change in mandibular flexure before and after splitting of the fixed full arch prosthesis
Measured: immediately after the splitting of the full arch fixed prosthesis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start20 Jan 2021
- Primary completion26 Oct 2022
- Study completion26 Oct 2022
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 Mandibular FlexureStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Medhat Sameh Abdelaziz, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617274
- Sponsor's protocol ID
- FUE.REC(26)/10-2022
- Status last verified
- Nov 2022
- First submitted
- 4 Nov 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol, raw data,statistics
Publications
El Charkawi H, Nassar HI, Abdelaziz MS. Retrospective digital study of mandibular flexure in patients with long-span fixed restorations supported by natural teeth. BMC Res Notes. 2023 Sep 11;16(1):203. doi: 10.1186/s13104-023-06486-w.
PubMed 37697386
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Digital Study of Mandibular Flexure in Patients With Long-span Fixed Restorations Supported by Natural Teeth.
- ClinicalTrials.gov ID
- NCT05617274
- Acronym / sponsor ID
- FUE.REC(26)/10-2022
- Conditions
- Mandibular Flexure, Full Arch Fixed Prosthesis
- Keywords
- Mandibular flexure, Prosthesis Failure, Full arch restorations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 15 Nov 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.
Nine patients (five males and four females) were included in this study who had long-term (10-15 years) of long-span rigid mandibular fixed prostheses that may have led to radiographic changes around the supporting teeth. The treatment plans included the removal of the long-span fixed rigid prostheses followed by restoring the patients with segmented implant-supported prostheses. In order to digitally measure the mandibular flexure, reference markers were adhered to the prostheses, and intraoral scans were obtained before and after splitting the preexisting prostheses at the minimum and maximum mouth opening. The distances between the markers were measured, and mandibular flexure was calculated by subtracting the distance between the markers during the maximum mouth opening from the minimum mouth opening. An independent sample T-test was used to compare mandibular flexure before and after splitting the long-span fixed prostheses.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mandibular flexure before sectioning of full arch fixed prosthesis | – | – |
| Mandibular flexure after sectioning of full arch fixed prosthesis | – | Procedure: Sectioning of the full arch mandibular fixed prosthesis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All had the entire mandibular natural dentition (6-8 abutments) splinted with a single-unit metal-ceramic (long-span fixed prosthesis). All of them suffered from different negative consequences of their one-piece fixed restorations. The retrospective collection of the patient's data was tabulated and analyzed. Nine patients were included in this study. Five males and four females, with an age range of 50-76 years were enrolled in this study.
Key inclusion criteria (2 listed)
- full-arch mandibular single fixed prostheses that served for many years (average 12 years) opposed by natural dentition.
- Patients were free from any systemic or debilitating diseases such as bone diseases, diabetes melilites, or blood dyscrasias.
Key exclusion criteria (4 listed)
- patients with healthy fixed full-arch prosthesis
- patients with segmented prosthesis
- patients with systematic debilitating diseases.
- Patients with temporomandibular joint dysfunction, maxillofacial surgeries, or mandibular trauma.
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 |
|---|---|---|
| Sectioning of the full arch mandibular fixed prosthesisThe one unit full arch fixed prosthesis is sectioned at the midline into two pieces | Procedure or surgery | Mandibular flexure after sectioning of full arch fixed prosthesis |
Primary outcome
change in mandibular flexure
Time frame: immediately after the splitting of the full arch fixed prosthesis.
change in mandibular flexure before and after splitting of the fixed full arch prosthesis
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 15 Nov 2022.
- Derived from this study: PubMed 37697386El Charkawi H, Nassar HI, Abdelaziz MS. Retrospective digital study of mandibular flexure in patients with long-span fixed restorations supported by natural teeth. BMC Res Notes. 2023 Sep 11;16(1):203. doi: 10.1186/s13104-023-06486-w.
- Individual participant dataSharing planned: Yes. study protocol, raw data,statistics
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 Mandibular Flexure and Full Arch Fixed Prosthesis, run by Future University in 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 2 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: finished, as of the sponsor's last update on 15 Nov 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?
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?
change in mandibular flexure (time frame: immediately after the splitting of the full arch fixed prosthesis.). 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 NCT05617274, 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 15 Nov 2022.