Maxillary Defect ReconstructionNCT07756983
Manual Dexterity of Patients With Bilateral Complete Maxillectomy Rehabilitated by Different Approaches (A Cross-over Study)
A study testing Dowel Pin in people with Maxillary Defect Reconstruction, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
10 participants received 2 piece obturators connected with magnet attachment, after 3 months the magnets were replaced by dowel pins and given to the participants for a further 3 months. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Maxillary Defect Reconstruction
- What is being tested?
- Dowel Pin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 May 2026
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- participants with complete bilateral maxillectomy,
- fully dentate mandible
Who cannot join
- participants who had undergone radiotherapy or chemotherapy within 12-13 months were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
10 participants received 2 piece obturators connected with magnet attachment, after 3 months the magnets were replaced by dowel pins and given to the participants for a further 3 months. Patient satisfaction was assessed at the end of the 3 months' follow-up by the form of a 3-level questionnaire (not satisfied, satisfied, or very satisfied). Participants were asked about how much they are satisfied by their prostheses regarding manual dexterity, retention, and stability. The McNemer test was used for all the 3 parameters (a=.05). Patients received Standardized Chewing Test Units (SCT) to measure their chewing efficiency. It is available in three different colored consistencies: soft and hard.
- Conditions
- Maxillary Defect Reconstruction
- Being tested
- Dowel Pin
- Keywords
- Total Maxillecomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dowel PinOther
Dowel Pin as a connector in two piece obturator for patients with total maxillectomy
| Study group | Role | What they receive |
|---|---|---|
| Magnet group | Experimental | Not described Receives: Other: Dowel Pin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patient satisfaction was assessed at the end of the 3 months' follow-up by the form of a 3-level questionnaire (not satisfied, satisfied, or very satisfied). Participants were asked about how much they are satisfied by their prostheses regarding manual dexterity, retention, and stability.
Measured: 3 Months
Secondary outcomes (1)
Chewing efficiency
Patients will receive Standardized Chewing Test Units (SCT) from BREDENT to measure their chewing efficiency. The SCT are standard-sized, spherical, prefabricated jelly testing units. It is available in three different colored consistencies. The patients will be tested with the soft and hard consistencies. The patient's ability to cut the rounded unit into pieces is used to measure their chewing efficiency; the more pieces they can cut, the more efficient they are. Patients will be allowed to chew for 10 chewing cycles, chewing cycles will be measured with electromyography
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Jan 2026
- Primary completion1 Feb 2026
- Study completion1 May 2026
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 Maxillary Defect ReconstructionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Nader Elsherbini, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756983
- Sponsor's protocol ID
- REC-D 472-5
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharaf MY. Patient satisfaction regarding conventional one-piece versus two-piece magnet-retained obturator for patients with complete edentulism: A preliminary crossover clinical trial. The Open Dentistry Journal. 2022 Jun 16;16(1).
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Dexterity of Patients With Bilateral Complete Maxillectomy Rehabilitated by Different Approaches (A Cross-over Study)
- ClinicalTrials.gov ID
- NCT07756983
- Acronym / sponsor ID
- REC-D 472-5
- Conditions
- Maxillary Defect Reconstruction
- Keywords
- Total Maxillecomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 11 Aug 2026 (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.
10 participants received 2 piece obturators connected with magnet attachment, after 3 months the magnets were replaced by dowel pins and given to the participants for a further 3 months. Patient satisfaction was assessed at the end of the 3 months' follow-up by the form of a 3-level questionnaire (not satisfied, satisfied, or very satisfied). Participants were asked about how much they are satisfied by their prostheses regarding manual dexterity, retention, and stability. The McNemer test was used for all the 3 parameters (a=.05). Patients received Standardized Chewing Test Units (SCT) to measure their chewing efficiency. It is available in three different colored consistencies: soft and hard.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnet group | Experimental | Other: Dowel Pin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- participants with complete bilateral maxillectomy,
- fully dentate mandible
Key exclusion criteria (1 listed)
- participants who had undergone radiotherapy or chemotherapy within 12-13 months were excluded from the study.
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 |
|---|---|---|
| Dowel PinDowel Pin as a connector in two piece obturator for patients with total maxillectomy | Other | Magnet group |
Primary outcome
Patient satisfaction
Time frame: 3 Months
Patient satisfaction was assessed at the end of the 3 months' follow-up by the form of a 3-level questionnaire (not satisfied, satisfied, or very satisfied). Participants were asked about how much they are satisfied by their prostheses regarding manual dexterity, retention, and stability.
1 secondary outcome
Chewing efficiency
Time frame: 3 Months
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 11 Aug 2026.
- Results publicationSharaf MY. Patient satisfaction regarding conventional one-piece versus two-piece magnet-retained obturator for patients with complete edentulism: A preliminary crossover clinical trial. The Open Dentistry Journal. 2022 Jun 16;16(1).
- Individual participant dataSharing planned: No
Related trials for Maxillary Defect Reconstruction
Not yet recruitingObservational study
Tongue and Occlusal Pressure Performance and Dietary Habits in Maxillectomy Patients With Obturator Prostheses
Maxillary Obturators, Maxillary Defect Reconstruction
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?
A study testing Dowel Pin in people with Maxillary Defect Reconstruction, run by October University for Modern Sciences and Arts 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 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 11 Aug 2026. 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?
Patient satisfaction (time frame: 3 Months). 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 NCT07756983, 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 11 Aug 2026.