Bilateral Edentulous Mandible (Kennedy Class I)OTCapNCT02924142
Treatment Outcomes After Receiving Conventional Clasp or Precision Attachment Removable Partial Dentures.
A study testing OT Cap attachment in people with Bilateral Edentulous Mandible (Kennedy Class I), run by Cairo University at 1 site in Egypt.
Trial summary
PICOTS: P: Kennedy class І patients I : Mandibular removable partial denture with OT Cap attachment C: Mandibular removable partial denture with gingival approaching clasp assembly O: 1ry outcome: Oral Health Related Quality of Life 2ry outcome: Biting force T: 1 Year S : Randomized control trial Research question: In… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bilateral Edentulous Mandible (Kennedy Class I)
- What is being tested?
- OT Cap attachment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2016to Nov 2018
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with mandibular free end saddle cases.
- Patients less than 75 years old.
- Patients who approved to be included in the trial and signed the informed consent.
- Patients are not suffering from diabetes mellitus.
Who cannot join
- Patients are suffering from diabetes mellitus.
- Patients above 75 years old.
- Patients are receiving chemotherapy or radiotherapy.
- Patients with severe Temporomandibular Joint problems.
- Patients who refused the trial.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Oral and Dental Medicine, Cairo University
Cairo, 11553
Yousr M. Mady, Professor, (+02)01006453846, Yusrmady@yahoo.com
About this study
Official title: Treatment Outcomes Based on Patient's Oral Health Related Quality of Life (OHRQoL) After Receiving Conventional Clasp or Precision Attachment Removable Partial Dentures in Distal Extension Cases: A Randomized Controlled Clinical Trial
PICOTS:
P: Kennedy class І patients
I : Mandibular removable partial denture with OT Cap attachment
C: Mandibular removable partial denture with gingival approaching clasp assembly
O: 1ry outcome: Oral Health Related Quality of Life
2ry outcome: Biting force
T: 1 Year
S : Randomized control trial
Research question:
In Kennedy class І patients will the removable partial denture with OT Cap attachment compared to conventional removable partial denture with clasp assembly results in difference in Oral Health Related Quality of Life of Patients?
Read the detailed description
In bilateral edentulous mandible with missing molars, the clasp retained partial denture will be compared with precision attachment partial denture for better quality of life for patients.
- Being tested
- OT Cap attachment
- Keywords
- Kennedy classification for edentulous ridge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OT Cap attachmentDevice
The RHEIN 83 OT CAP attachment system is an extra-coronal castable attachment positioned on the distal of the abutment crowns as an extension allowing a lot of vertical space for optimal esthetics.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Mandibular removable partial denture with OT Cap attachment Receives: Device: OT Cap attachment |
| Comparator | No intervention | Mandibular removable partial denture with gingival approaching clasp assembly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Health Related Quality of Life
Questionnaire
Measured: 1 Year
Secondary outcomes (1)
Biting force
i-load Star Sensor
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Edentulous Mandible (Kennedy Class I)Studies 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Hassan, Cairo University
- Investigators
- Yousr M. Mady, Professor, Study director, Faculty of Oral and Dental Medicine, Cairo University, Cairo, EgyptAhmed M. Fayyad, A. Professor, Study director, Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924142
- Sponsor's protocol ID
- CEBD-CU-2016-09-212
- Acronym
- OTCap
- Status last verified
- Oct 2016
- First submitted
- 3 Oct 2016
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcomes Based on Patient's Oral Health Related Quality of Life (OHRQoL) After Receiving Conventional Clasp or Precision Attachment Removable Partial Dentures in Distal Extension Cases: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02924142
- Acronym / sponsor ID
- OTCap / CEBD-CU-2016-09-212
- Keywords
- Kennedy classification for edentulous ridge
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 5 Oct 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.
PICOTS:
P: Kennedy class І patients
I : Mandibular removable partial denture with OT Cap attachment
C: Mandibular removable partial denture with gingival approaching clasp assembly
O: 1ry outcome: Oral Health Related Quality of Life
2ry outcome: Biting force
T: 1 Year
S : Randomized control trial
Research question:
In Kennedy class І patients will the removable partial denture with OT Cap attachment compared to conventional removable partial denture with clasp assembly results in difference in Oral Health Related Quality of Life of Patients?
Detailed description
In bilateral edentulous mandible with missing molars, the clasp retained partial denture will be compared with precision attachment partial denture for better quality of life for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: OT Cap attachmentMandibular removable partial denture with OT Cap attachment |
| Comparator | No intervention | –Mandibular removable partial denture with gingival approaching clasp assembly |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with mandibular free end saddle cases.
- Patients less than 75 years old.
- Patients who approved to be included in the trial and signed the informed consent.
- Patients are not suffering from diabetes mellitus.
Key exclusion criteria (5 listed)
- Patients are suffering from diabetes mellitus.
- Patients above 75 years old.
- Patients are receiving chemotherapy or radiotherapy.
- Patients with severe Temporomandibular Joint problems.
- Patients who refused the trial.
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 Cap attachmentThe RHEIN 83 OT CAP attachment system is an extra-coronal castable attachment positioned on the distal of the abutment crowns as an extension allowing a lot of vertical space for optimal esthetics. | Device | Intervention |
Primary outcome
Oral Health Related Quality of Life
Time frame: 1 Year
Questionnaire
1 secondary outcome
Biting force
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Individual participant dataSharing planned: Undecided
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.
Yousr M. Mady, Professor study director
Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt
Ahmed M. Fayyad, A. Professor study director
Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OT Cap attachment in people with Bilateral Edentulous Mandible (Kennedy Class I), run by Cairo 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 4 inclusion and 5 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 5 Oct 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rania M. Hassan, MSC ((+02) 010 018 05207 ext. (+02) 24041357, rtmohamza2004@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Health Related Quality of Life (time frame: 1 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 Oct 2016.