Patient SatisfactionNCT03221803
Patient Satisfaction and Bone Changes for OT Cap and OT Vertical Attachment
A study testing OT Vertical attachment and OT cap attachment in people with Patient Satisfaction and Bone Changes, run by Cairo University.
Trial summary
The purpose of this study aimed to answer a clinical question whether In a patient with bilateral distal extension area, would the metal framework partial denture with OT vertical attachment versus partial denture with OT CAP attachment result in better patient satisfaction? Read more about this study
- Who is it for?
- Ages 35 to 45 years
- Conditions the study is for
- Patient Satisfaction, Bone Changes
- What is being tested?
- OT Vertical attachment and OT cap attachment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to Mar 2019
- 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 35 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients age ranged between 35-45years old.
- All patients have Kennedy class I partially edentulous mandibular arch in which the last remaining teeth were the second premolars bilaterally.
- The abutment teeth had an apparently good periodontal condition with no signs of mobility or inflammation with firm and healthy mucosa.
- Edentulous ridge covered by health firm mucoperiosteum, without abnormal bony irregularity or severe lingual undercuts.
- Patients with normal relationship of maxilla and mandible (Angle class I ridge classification) and sufficient inter-arch space (6mm) the size of the attachment
- The opposing dentition is intact arch with no noticeable over eruption or tilting or restored with acceptable fixed restoration.
- All patients are free from neurological, muscular disorders and tempro-mandibular joint disorders.
- Only patients who can be easily motivated to achieve and maintain good oral
Who cannot join
- Patient with limited skills
- Un co-operative patients.
- patient with bad oral hygiene
Trial locations and contacts
No sites are listed yet.
Yusr Mady contact
About this study
Official title: Patient Satisfaction and Bone Changes in Bilateral Distal Extension Case Using OT Cap Versus OT Vertical Attachment "Randomized Clinical Trial"
The purpose of this study aimed to answer a clinical question whether In a patient with bilateral distal extension area, would the metal framework partial denture with OT vertical attachment versus partial denture with OT CAP attachment result in better patient satisfaction?
- Conditions
- Patient Satisfaction, Bone Changes
- Being tested
- OT Vertical attachment, OT cap attachment
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OT Vertical attachmentOther
Also called Castable twin cylinder attachment
new extra coronal castable attachment
OT cap attachmentOther
Also called extra coronal castable attachment
standard extra coronal attachment
| Study group | Role | What they receive |
|---|---|---|
| OT Vertical attachment | Experimental | The attachment consists of a male part that is in the form of a steady with a central hole. This part is attached to the abutments .the female component is a white standard retentive clip engaging the outer walls of a steady male. It is incorporated in the partial denture together with a castable balancing pin that fits into the central hole of the steady male and aids in centering the prosthesis during the final stage of insertion; thereby ensuring a longer life to the retentive clips. Receives: Other: OT Vertical attachment |
| OT Cap attachment | Active comparator | Beveled castable bar with micro-size sphere located in first molar region, and attached to the distal surface of the waxed crowns to be cast as one piece, Nylone caps of standard retention for micro size sphere this nylon caps fit onto their spheres and located in metal housing at fitting surface on the denture and Positioning rings to maintain the space for nylon cap during construction of the partial denture metal framework. Receives: Other: OT cap attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction assessed using questionnaire
Questionnaire for patient satisfaction
Measured: 9 months
Secondary outcomes (2)
bone height
radio graphically by digora
Measured: 9 months
bone density
radio graphically by digora
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start1 Jan 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionMar 2019 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ali Hassaan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221803
- Sponsor's protocol ID
- OT Cap_OT Vertical
- Status last verified
- Jul 2017
- First submitted
- 17 Jul 2017
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Bone Changes in Bilateral Distal Extension Case Using OT Cap Versus OT Vertical Attachment "Randomized Clinical Trial"
- ClinicalTrials.gov ID
- NCT03221803
- Acronym / sponsor ID
- OT Cap_OT Vertical
- Conditions
- Patient Satisfaction, Bone Changes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 19 Jul 2017 (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 purpose of this study aimed to answer a clinical question whether In a patient with bilateral distal extension area, would the metal framework partial denture with OT vertical attachment versus partial denture with OT CAP attachment result in better patient satisfaction?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OT Vertical attachment | Experimental | Other: OT Vertical attachmentThe attachment consists of a male part that is in the form of a steady with a central hole. This part is attached to the abutments .the female component is a white standard retentive clip engaging the outer walls of a steady male. It is incorporated in the partial denture together with a castable balancing pin that fits into the central hole of the steady male and aids in centering the prosthesis during the final stage of insertion; thereby ensuring a longer life to the retentive clips. |
| OT Cap attachment | Active comparator | Other: OT cap attachmentBeveled castable bar with micro-size sphere located in first molar region, and attached to the distal surface of the waxed crowns to be cast as one piece, Nylone caps of standard retention for micro size sphere this nylon caps fit onto their spheres and located in metal housing at fitting surface on the denture and Positioning rings to maintain the space for nylon cap during construction of the partial denture metal framework. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- patients age ranged between 35-45years old.
- All patients have Kennedy class I partially edentulous mandibular arch in which the last remaining teeth were the second premolars bilaterally.
- The abutment teeth had an apparently good periodontal condition with no signs of mobility or inflammation with firm and healthy mucosa.
- Edentulous ridge covered by health firm mucoperiosteum, without abnormal bony irregularity or severe lingual undercuts.
- Patients with normal relationship of maxilla and mandible (Angle class I ridge classification) and sufficient inter-arch space (6mm) the size of the attachment
Key exclusion criteria (3 listed)
- Patient with limited skills
- Un co-operative patients.
- patient with bad oral hygiene
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 |
|---|---|---|
| OT Vertical attachmentAlso: Castable twin cylinder attachmentnew extra coronal castable attachment | Other | OT Vertical attachment |
| OT cap attachmentAlso: extra coronal castable attachmentstandard extra coronal attachment | Other | OT Cap attachment |
Primary outcome
patient satisfaction assessed using questionnaire
Time frame: 9 months
Questionnaire for patient satisfaction
2 secondary outcomes
bone height
Time frame: 9 months
bone density
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
Yusr Mady contact
Questions about this trial
What is this clinical trial studying?
A study testing OT Vertical attachment and OT cap attachment in people with Patient Satisfaction and Bone Changes, 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 8 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: status not confirmed, as of the sponsor's last update on 19 Jul 2017. 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?
Contact Ahmed Hassaan, PHD (01021722944, ahmedhassan871983@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction assessed using questionnaire (time frame: 9 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 19 Jul 2017; AzTrials last refreshed its copy on 30 Oct 2026.