Patient SatisfactionNCT05882617
Patient Satisfaction With Different Numbers of Implants
A study testing implants supported overdentures in people with Patient Satisfaction, run by Cairo University at 2 sites in Egypt.
Trial summary
the goal of this randomized controlled trial aimed to assess patient satisfaction for completely edentulous patients with implant overdenture retained by ball attachment over a single symphyseal , or four interforaminal implants when compared to two interforaminal ones Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- implants supported overdentures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesEgypt
- Study dates
- 12 Jan 2021to 10 Jan 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- completely edentulous patients with restorative space of 12-15 mm,
- keratinized gingiva of 5 mm
Who cannot join
- uncontrolled diabetes
- bruxers
- smokers
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Assessment of Patient Satisfaction in Completely Edentulous Patients Receiving Removable Implant Overdentures Retained by Different Numbers of Implants .A Randomized Clinical Trial
the goal of this randomized controlled trial aimed to assess patient satisfaction for completely edentulous patients with implant overdenture retained by ball attachment over a single symphyseal , or four interforaminal implants when compared to two interforaminal ones
Read the detailed description
48 edentulous patients were recruited and randomized to receive either 1,2 or 4 implants for a mandibular overdenture,3 months later implants were uncovered, and ball attachments were torqued, and all overdentures were picked up ,patient satisfaction questionnaires were recorded for all patients 2 weeks after pickup 3 months ,6 months, 9 months and 1year.
- Conditions
- Patient Satisfaction
- Being tested
- implants supported overdentures
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implants supported overdenturesOther
implant supported and retained with different number of implants retained by ball attachments
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | single impalnts supported overdenture Receives: Other: implants supported overdentures |
| active comparator | Active comparator | two implants supported overdenture Receives: Other: implants supported overdentures |
| others | Other | four implants supported overdenture Receives: Other: implants supported overdentures |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction for masticatory ability, mental life comfortability with dentures
A translated into Arabic form of patient satisfaction questionnaire to match the language and environmental background of the patients was answered by all subjects, Each response was given a score range from 0 to 4 where zero represents the best result . Questionnaire was divided into three categories questions, the first section was a direct questions to the patient answered by one of some choices, and each choice had a number which will be summed up and giving a score, The second section was a visual answered question; in which patient chose from best to worst on a given scale. The marked point will be translated into a number from zero (the best) to ten (the worst). The third section was a YES/ NO questions, answered shortly by the patient in the terms of yes or No.
A translated into Arabic form of patient satisfaction questionnaire to match the language and environmental background of the patients was answered by all subjects
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 May 2023
- Study start12 Jan 2021
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- three parallel arms one comparator and two interventions
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Mohamed awaad, Cairo University
- Investigators
- Doaa Elkady phd, Study director, lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882617
- Sponsor's protocol ID
- 33922
- Status last verified
- Jun 2023
- First submitted
- 20 May 2023
- Last updated
- 5 Jun 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 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patient Satisfaction in Completely Edentulous Patients Receiving Removable Implant Overdentures Retained by Different Numbers of Implants .A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05882617
- Acronym / sponsor ID
- 33922
- Conditions
- Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 31 May 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.
the goal of this randomized controlled trial aimed to assess patient satisfaction for completely edentulous patients with implant overdenture retained by ball attachment over a single symphyseal , or four interforaminal implants when compared to two interforaminal ones
Detailed description
48 edentulous patients were recruited and randomized to receive either 1,2 or 4 implants for a mandibular overdenture,3 months later implants were uncovered, and ball attachments were torqued, and all overdentures were picked up ,patient satisfaction questionnaires were recorded for all patients 2 weeks after pickup 3 months ,6 months, 9 months and 1year.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- three parallel arms one comparator and two interventions
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: implants supported overdenturessingle impalnts supported overdenture |
| active comparator | Active comparator | Other: implants supported overdenturestwo implants supported overdenture |
| others | Other | Other: implants supported overdenturesfour implants supported overdenture |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- completely edentulous patients with restorative space of 12-15 mm,
- keratinized gingiva of 5 mm
Key exclusion criteria (3 listed)
- uncontrolled diabetes
- bruxers
- smokers
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 |
|---|---|---|
| implants supported overdenturesimplant supported and retained with different number of implants retained by ball attachments | Other | active comparator, experimental, others |
Primary outcome
patient satisfaction for masticatory ability, mental life comfortability with dentures
Time frame: one year
A translated into Arabic form of patient satisfaction questionnaire to match the language and environmental background of the patients was answered by all subjects, Each response was given a score range from 0 to 4 where zero represents the best result . Questionnaire was divided into three categories questions, the first section was a direct questions to the patient answered by one of some choices, and each choice had a number which will be summed up and giving a score, The second section was a visual answered question; in which patient chose from best to worst on a given scale. The marked point will be translated into a number from zero (the best) to ten (the worst). The third section was a YES/ NO questions, answered shortly by the patient in the terms of yes or No. A translated into Arabic form of patient satisfaction questionnaire to match the language and environmental background of the patients was answered by all subjects
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 5 Jun 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.
Doaa Elkady phd study director
lecturer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implants supported overdentures in people with Patient Satisfaction, run by Cairo University at 2 sites 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 3 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 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 for masticatory ability, mental life comfortability with dentures (time frame: one year). 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 5 Jun 2023; AzTrials last refreshed its copy on 3 Nov 2026.