Patient Acceptance of Health CareNCT02951507
Evaluation of Patient Satisfaction and Biting Force of New Design of Extracoronal Attachment (O T Cap Unilateral Attachment) Versus Conventional Partial Denture for Treatment of Unilateral Mandibular Distal Extension Area
A study testing O T unilateral attachment and New design of extracoronal attachment system in people with Patient Acceptance of Health Care, run by Cairo University.
Trial summary
Comparison of new design of extra coronal castable precision attachment (OT unilateral attachment) and conventional partial denture in patient satisfaction and biting force. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Acceptance of Health Care
- What is being tested?
- O T unilateral attachment and New design of extracoronal attachment system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2017
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with unilateral mandibular distal extension area
- Normal crown/root ratio of last premolar
- co-operative patients
Who cannot join
- completely edentulous patient
- few remaining teeth
- patients exposed to radiotherapy and chemotherapy
- patients with maxillary or mandibular defect
About this study
Comparison of new design of extra coronal castable precision attachment (OT unilateral attachment) and conventional partial denture in patient satisfaction and biting force.
- Conditions
- Patient Acceptance of Health Care
- Being tested
- O T unilateral attachment, New design of extracoronal attachment system
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O T unilateral attachmentOther
O T unilateral attachment system
New design of extracoronal attachment systemOther
O T unilateral attachment
| Study group | Role | What they receive |
|---|---|---|
| Conventional partial denture | Active comparator | Intervention will be O T unilateral attachment Receives: Other: O T unilateral attachment |
| Conventional removal partial denture | Active comparator | Intervention will be new design of extra coronal attachment( O T unilateral attachment) Receives: Other: New design of extracoronal attachment system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
OHIP-14 questionnaire
Measured: 12 months
Secondary outcomes (1)
Biting force
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Acceptance of Health CareStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed mamdouh afify, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951507
- Sponsor's protocol ID
- CEBD-CU-2016-10-232
- Status last verified
- Oct 2016
- First submitted
- 29 Oct 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Satisfaction and Biting Force of New Design of Extracoronal Attachment (O T Cap Unilateral Attachment) Versus Conventional Partial Denture for Treatment of Unilateral Mandibular Distal Extension Area
- ClinicalTrials.gov ID
- NCT02951507
- Acronym / sponsor ID
- CEBD-CU-2016-10-232
- Conditions
- Patient Acceptance of Health Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (estimated)
- First posted
- 1 Nov 2016 (estimated)
- 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.
Comparison of new design of extra coronal castable precision attachment (OT unilateral attachment) and conventional partial denture in patient satisfaction and biting force.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional partial denture | Active comparator | Other: O T unilateral attachmentIntervention will be O T unilateral attachment |
| Conventional removal partial denture | Active comparator | Other: New design of extracoronal attachment systemIntervention will be new design of extra coronal attachment( O T unilateral attachment) |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients with unilateral mandibular distal extension area
- Normal crown/root ratio of last premolar
- co-operative patients
Key exclusion criteria (4 listed)
- completely edentulous patient
- few remaining teeth
- patients exposed to radiotherapy and chemotherapy
- patients with maxillary or mandibular defect
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 |
|---|---|---|
| O T unilateral attachmentO T unilateral attachment system | Other | Conventional partial denture |
| New design of extracoronal attachment systemO T unilateral attachment | Other | Conventional removal partial denture |
Primary outcome
Patient satisfaction
Time frame: 12 months
OHIP-14 questionnaire
1 secondary outcome
Biting force
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing O T unilateral attachment and New design of extracoronal attachment system in people with Patient Acceptance of Health Care, run by Cairo University.
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 4 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 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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: 12 months). 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 1 Nov 2016.