Bone ResorptionNCT05910333
Four Locator Attachment Mandibular Overdentures
An observational study of Bone Resorption, run by Mohamed Elsawy at 1 site in Egypt.
Trial summary
. There is little information on the degree of crestal bone loss around 4 inter-foraminal implant-retained mandibular overdentures (OVDs) and the amount of bone remodelling on the anterior maxilla and posterior mandibule on long-term function, particularly with different distributions. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Bone Resorption
- What is being tested?
- observation
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Mar 2023to 27 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 55 to 80 years
- All sexes
- Adult, Older adult
Study population: 10 patients in each group. total number of patients 20.
Who may be able to join
- Patients with 4 implants in the inter-foraminal region.
- Patients treated by staff and students in the Master's program in Prosthodontics Department according to the following criteria:
- Edentulous maxilla and mandible for at least 1 year.
- Problems with retention and stability of the mandibular denture.
- Mandibular bone height between 15 and 25 mm.
Who cannot join
- Patients with relative contraindications, such as
- A history of para functional habits.
- Smokers more than 10 cigarettes per day.
- alcoholism.
- Patients with a history of radiation therapy in the head and neck region . • Patients within intravenous administrated bisphosphonates., chemotherapy, and mental disorders that could jeopardies their co-operation.
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: Ten Years Retrospective Study of 4 LOCATOR Attachment of Mandibular Implant Retained Overdenture With 2 Different Distributions.
. There is little information on the degree of crestal bone loss around 4 inter-foraminal implant-retained mandibular overdentures (OVDs) and the amount of bone remodelling on the anterior maxilla and posterior mandibule on long-term function, particularly with different distributions.
Read the detailed description
Numerous studies confirm the successful use of implants to retain prostheses in the edentulous atrophic mandible. It has been recommended by some authors that clinicians should use 3 or 4 implants in situations that require increased retention, such as high muscle attachment or prominent mylohyoid ridge. LOCATOR attachment as a retentive component has several advantages over other systems, Such as: dual retention through both external and internal mating surfaces, a self-aligning feature which is helpful in guiding patients when placing their denture. There is little information on the degree of crestal bone loss around 4 inter-foraminal implant-retained mandibular overdentures (OVDs) and the amount of bone remodelling on the anterior maxilla and posterior mandibule on long-term function, particularly with different distributions.
- Conditions
- Bone Resorption
- Being tested
- observation
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
To compare the effect of the mandibular implant retained OVD using quadrilateral distribution (QD) versus linear distribution (LD) on posterior mandibular ridge resorption (PMandRR), anterior maxillary ridge resorption (AMaxRR), and changes to the crestal bone level around implants after 10 years of function.
| Study group | Role | What they receive |
|---|---|---|
| Quadrilateral distribution group | Patients with quadrilateral distribution of implants Receives: Other: observation | |
| Linear distribution group | Patients with lineardistribution of implants Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posterior mandibular ridge resorption (PMandRR)
The amount of PMandRR will be assessed using posterior area index on a panoramic x-ray which use specific landmarkds.
Measured: 10 years retrospective study
Secondary outcomes (1)
Anterior maxillary ridge resorption (AMaxRR)
The amount of PMandRR will be assessed using anterior area index on a panoramic x-ray, which use specific landmarks.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start28 Mar 2023
- Primary completion21 Oct 2023 (estimated)
- Study completion27 Oct 2023 (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.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Elsawy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Elsawy, Mansoura University
- Investigators
- Mohammed E Sawy, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910333
- Sponsor's protocol ID
- A0103023RP
- Status last verified
- Oct 2023
- First submitted
- 9 Jun 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
- Ten Years Retrospective Study of 4 LOCATOR Attachment of Mandibular Implant Retained Overdenture With 2 Different Distributions.
- ClinicalTrials.gov ID
- NCT05910333
- Acronym / sponsor ID
- A0103023RP
- Conditions
- Bone Resorption
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mohamed ElsawyUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 21 Oct 2023 (estimated)
- Study completion
- 27 Oct 2023 (estimated)
- First posted
- 18 Jun 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.
. There is little information on the degree of crestal bone loss around 4 inter-foraminal implant-retained mandibular overdentures (OVDs) and the amount of bone remodelling on the anterior maxilla and posterior mandibule on long-term function, particularly with different distributions.
Detailed description
Numerous studies confirm the successful use of implants to retain prostheses in the edentulous atrophic mandible. It has been recommended by some authors that clinicians should use 3 or 4 implants in situations that require increased retention, such as high muscle attachment or prominent mylohyoid ridge. LOCATOR attachment as a retentive component has several advantages over other systems, Such as: dual retention through both external and internal mating surfaces, a self-aligning feature which is helpful in guiding patients when placing their denture. There is little information on the degree of crestal bone loss around 4 inter-foraminal implant-retained mandibular overdentures (OVDs) and the amount of bone remodelling on the anterior maxilla and posterior mandibule on long-term function, particularly with different distributions.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadrilateral distribution group | – | Other: observationPatients with quadrilateral distribution of implants |
| Linear distribution group | – | Other: observationPatients with lineardistribution of implants |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 10 patients in each group. total number of patients 20.
Key inclusion criteria (5 listed)
- Patients with 4 implants in the inter-foraminal region.
- Patients treated by staff and students in the Master's program in Prosthodontics Department according to the following criteria:
- Edentulous maxilla and mandible for at least 1 year.
- Problems with retention and stability of the mandibular denture.
- Mandibular bone height between 15 and 25 mm.
Key exclusion criteria (5 listed)
- Patients with relative contraindications, such as
- A history of para functional habits.
- Smokers more than 10 cigarettes per day.
- alcoholism.
- Patients with a history of radiation therapy in the head and neck region . • Patients within intravenous administrated bisphosphonates., chemotherapy, and mental disorders that could jeopardies their co-operation.
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 |
|---|---|---|
| observationTo compare the effect of the mandibular implant retained OVD using quadrilateral distribution (QD) versus linear distribution (LD) on posterior mandibular ridge resorption (PMandRR), anterior maxillary ridge resorption (AMaxRR), and changes to the crestal bone level around implants after 10 years of function. | Other | Linear distribution group, Quadrilateral distribution group |
Primary outcome
Posterior mandibular ridge resorption (PMandRR)
Time frame: 10 years retrospective study
The amount of PMandRR will be assessed using posterior area index on a panoramic x-ray which use specific landmarkds.
1 secondary outcome
Anterior maxillary ridge resorption (AMaxRR)
Time frame: 10 years
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 E Sawy study director
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 Bone Resorption, run by Mohamed Elsawy 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 5 inclusion and 5 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 E Sawy, PhD (+201061314522, Dr_sawy@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posterior mandibular ridge resorption (PMandRR) (time frame: 10 years retrospective study). 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.