Prosthesis UserNCT06109792
Patient Satisfaction and Oral Health-related Quality of Life (OHRQL) For Two Pick-up Techniques
A study testing implant supported mandibular overdenture in people with Prosthesis User, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aimed to evaluate patient satisfaction and OHRQL using two pick-up methods for locator retained mandibular overdenture 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 mandibular overdenture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2021to 16 Aug 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 will have two implants placed in the mandibular interforaminal region.
- 2. All selected patients have a healthy mucosa and have no clinical complications.
- 3. All patients are cooperative and approve of the proposed treatment protocol
Who cannot join
- 1. Patients who refuse 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: Patient Satisfaction and Oral Health-related Quality of Life (OHRQL) For Two Pick-up Techniques of the Locator Retentive Caps for Two Implant-supported Mandibular Overdentures: A Crossover Study
This study aimed to evaluate patient satisfaction and OHRQL using two pick-up methods for locator retained mandibular overdenture
- Conditions
- Prosthesis User
- Being tested
- implant supported mandibular overdenture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant supported mandibular overdentureProcedure or surgery
In this crossover study, the patients received overdentures with two successive different pick-up techniques for the locator retentive caps; each technique was evaluated for patient satisfaction with blue and pink retentive inserts.
| Study group | Role | What they receive |
|---|---|---|
| • Group I | Active comparator | Ten overdentures with locator retentive caps and blue inserts were picked up by the indirect method. Receives: Procedure: implant supported mandibular overdenture |
| • Group II | Active comparator | Ten overdentures with locator retentive caps and pink inserts were picked up by the indirect method. Receives: Procedure: implant supported mandibular overdenture |
| Group III | Active comparator | Ten overdentures with locator retentive caps and blue inserts were picked up by the direct method. Receives: Procedure: implant supported mandibular overdenture |
| Group IV | Active comparator | Ten overdentures with locator retentive caps and pink inserts were picked up by the direct method. Receives: Procedure: implant supported mandibular overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
patient satisfaction was recorded using score system on a scale from 0 to 100
Measured: One year
oral health related quality of life
Oral health related quality of life was evaluated by using scoring system
Measured: one year
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 start10 Apr 2021
- Primary completion20 Jun 2022
- Study completion16 Aug 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.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Group I: Ten overdentures with locator retentive caps and blue inserts were picked up by the indirect method. Group II: Ten overdentures with locator retentive caps and pink inserts were picked up by the indirect method. Group III: Ten overdentures with locator retentive caps and blue inserts were picked up by the direct method. Group IV: Ten overdentures with locator retentive caps and pink inserts were picked up by the direct method.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 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
- NCT06109792
- Sponsor's protocol ID
- A0108023RP
- 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
- Patient Satisfaction and Oral Health-related Quality of Life (OHRQL) For Two Pick-up Techniques of the Locator Retentive Caps for Two Implant-supported Mandibular Overdentures: A Crossover Study
- ClinicalTrials.gov ID
- NCT06109792
- Acronym / sponsor ID
- A0108023RP
- Conditions
- Prosthesis User
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 16 Aug 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 aimed to evaluate patient satisfaction and OHRQL using two pick-up methods for locator retained mandibular overdenture
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Group I: Ten overdentures with locator retentive caps and blue inserts were picked up by the indirect method. Group II: Ten overdentures with locator retentive caps and pink inserts were picked up by the indirect method. Group III: Ten overdentures with locator retentive caps and blue inserts were picked up by the direct method. Group IV: Ten overdentures with locator retentive caps and pink inserts were picked up by the direct method.
| Arm | Type | Receives |
|---|---|---|
| • Group I | Active comparator | Procedure: implant supported mandibular overdentureTen overdentures with locator retentive caps and blue inserts were picked up by the indirect method. |
| • Group II | Active comparator | Procedure: implant supported mandibular overdentureTen overdentures with locator retentive caps and pink inserts were picked up by the indirect method. |
| Group III | Active comparator | Procedure: implant supported mandibular overdentureTen overdentures with locator retentive caps and blue inserts were picked up by the direct method. |
| Group IV | Active comparator | Procedure: implant supported mandibular overdentureTen overdentures with locator retentive caps and pink inserts were picked up by the direct method. |
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 will have two implants placed in the mandibular interforaminal region.
- 2. All selected patients have a healthy mucosa and have no clinical complications.
- 3. All patients are cooperative and approve of the proposed treatment protocol
Key exclusion criteria (1 listed)
- 1. Patients who refuse 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 mandibular overdentureIn this crossover study, the patients received overdentures with two successive different pick-up techniques for the locator retentive caps; each technique was evaluated for patient satisfaction with blue and pink retentive inserts. | Procedure or surgery | Group III, Group IV, • Group I, • Group II |
Primary outcome
patient satisfaction
Time frame: One year
patient satisfaction was recorded using score system on a scale from 0 to 100
oral health related quality of life
Time frame: one year
Oral health related quality of life was evaluated by using scoring system
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 mandibular 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?
patient satisfaction (time frame: One year). 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.