Prosthesis UserNCT06109519
Comparative Clinical Study for Two Types of Locator Attachments for Mandibular Implant Supported Overdenture
A study testing implant supported overdenture in people with Prosthesis User, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aims to evaluate the clinical and radiographic outcomes for mandibular implant-supported overdenture using two different types of locator attachment after 3 years of using the two types of locator attachments Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis User
- What is being tested?
- implant supported overdenture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Feb 2020to 16 Sep 2023
- 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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. All selected patients have two implants placed in the mandibular interforaminal region.
- 2. All selected patients have a healthy mucosa and with no clinical complications.
- 3. All patients are cooperative and approve the proposed treatment protocol
Who cannot join
- 1. Patients who reject to participate in the study. 2.Patients who need implant placement as a result of previous implant failure
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University ,Faculty of dentistry
Al Mansurah, P.O.Box:35516
About this study
Official title: A Comparative Clinical Study for Two Types of Locator Attachments for Mandibular Implant-supported Overdenture; A 3-year Radiographic and Clinical Follow-up Study
This study aims to evaluate the clinical and radiographic outcomes for mandibular implant-supported overdenture using two different types of locator attachment after 3 years of using the two types of locator attachments
- Conditions
- Prosthesis User
- Being tested
- implant supported overdenture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant supported overdentureProcedure or surgery
patients would be delivered mandibular implant overdenture using conventional locator and Locator RTX attachments
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | patients who would be delivered a mandibular implant overdenture using conventional locator attachments. Receives: Procedure: implant supported overdenture |
| Group II (study) | Active comparator | patients who would be delivered mandibular implant overdenture using Locator RTX attachments Receives: Procedure: implant supported overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
crestal cone loss
Intraoral radiographs were performed using the long cone paralleling technique to evaluate crestal bone loss
Measured: three years
prosthetic complications
prosthetic complications were scored clinically
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start16 Feb 2020
- Primary completion7 Jun 2022
- Study completion16 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis UserStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All patients in this study will be divided into two equal groups Group I (control): patients who would be delivered mandibular implant overdenture using conventional locator attachments. Group II (study): patients who would be delivered mandibular implant overdenture using Locator RTX attachments
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109519
- Sponsor's protocol ID
- A0208023RP
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Clinical Study for Two Types of Locator Attachments for Mandibular Implant-supported Overdenture; A 3-year Radiographic and Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT06109519
- Acronym / sponsor ID
- A0208023RP
- Conditions
- Prosthesis User
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 16 Feb 2020 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 16 Sep 2023 (actual)
- First posted
- 31 Oct 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.
This study aims to evaluate the clinical and radiographic outcomes for mandibular implant-supported overdenture using two different types of locator attachment after 3 years of using the two types of locator attachments
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All patients in this study will be divided into two equal groups Group I (control): patients who would be delivered mandibular implant overdenture using conventional locator attachments. Group II (study): patients who would be delivered mandibular implant overdenture using Locator RTX attachments
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Procedure: implant supported overdenturepatients who would be delivered a mandibular implant overdenture using conventional locator attachments. |
| Group II (study) | Active comparator | Procedure: implant supported overdenturepatients who would be delivered mandibular implant overdenture using Locator RTX attachments |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. All selected patients have two implants placed in the mandibular interforaminal region.
- 2. All selected patients have a healthy mucosa and with no clinical complications.
- 3. All patients are cooperative and approve the proposed treatment protocol
Key exclusion criteria (1 listed)
- 1. Patients who reject to participate in the study. 2.Patients who need implant placement as a result of previous implant failure
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 |
|---|---|---|
| implant supported overdenturepatients would be delivered mandibular implant overdenture using conventional locator and Locator RTX attachments | Procedure or surgery | Group I, Group II (study) |
Primary outcome
crestal cone loss
Time frame: three years
Intraoral radiographs were performed using the long cone paralleling technique to evaluate crestal bone loss
prosthetic complications
Time frame: three years
prosthetic complications were scored clinically
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 31 Oct 2023.
- Individual participant dataSharing planned: No
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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?
A study testing implant supported overdenture in people with Prosthesis User, 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 3 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 31 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?
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?
crestal cone loss (time frame: three years). The study lists 2 primary outcomes in all. 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 31 Oct 2023.