Treatment Outcomes After Receiving Conventional Clasp or Precision Attachment Removable Partial Dentures.
OTCap
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
1 other identifier
interventional
32
1 country
1
Brief 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 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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2016
CompletedFirst Posted
Study publicly available on registry
October 5, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedOctober 5, 2016
October 1, 2016
1 year
October 3, 2016
October 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oral Health Related Quality of Life
Questionnaire
1 Year
Secondary Outcomes (1)
Biting force
1 Year
Study Arms (2)
Intervention
EXPERIMENTALMandibular removable partial denture with OT Cap attachment
Comparator
NO INTERVENTIONMandibular removable partial denture with gingival approaching clasp assembly
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Oral and Dental Medicine, Cairo University
Cairo, 11553, Egypt
Study Officials
- STUDY DIRECTOR
Yousr M. Mady, Professor
Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt
- STUDY DIRECTOR
Ahmed M. Fayyad, A. Professor
Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dentist
Study Record Dates
First Submitted
October 3, 2016
First Posted
October 5, 2016
Study Start
November 1, 2016
Primary Completion
November 1, 2017
Study Completion
November 1, 2018
Last Updated
October 5, 2016
Record last verified: 2016-10