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Treatment Outcomes After Receiving Conventional Clasp or Precision Attachment Removable Partial Dentures. (OTCap)

Primary Purpose

Bilateral Edentulous Mandible (Kennedy Class I)

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
OT Cap attachment
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bilateral Edentulous Mandible (Kennedy Class I) focused on measuring Kennedy classification for edentulous ridge

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients with mandibular free end saddle cases.
  2. Patients less than 75 years old.
  3. Patients who approved to be included in the trial and signed the informed consent.
  4. Patients are not suffering from diabetes mellitus.

Exclusion Criteria:

  1. Patients are suffering from diabetes mellitus.
  2. Patients above 75 years old.
  3. Patients are receiving chemotherapy or radiotherapy.
  4. Patients with severe Temporomandibular Joint problems.
  5. Patients who refused the trial.

Sites / Locations

  • Faculty of Oral and Dental Medicine, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Comparator

Arm Description

Mandibular removable partial denture with OT Cap attachment

Mandibular removable partial denture with gingival approaching clasp assembly

Outcomes

Primary Outcome Measures

Oral Health Related Quality of Life
Questionnaire

Secondary Outcome Measures

Biting force
i-load Star Sensor

Full Information

First Posted
October 3, 2016
Last Updated
October 3, 2016
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02924142
Brief Title
Treatment Outcomes After Receiving Conventional Clasp or Precision Attachment Removable Partial Dentures.
Acronym
OTCap
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Edentulous Mandible (Kennedy Class I)
Keywords
Kennedy classification for edentulous ridge

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Mandibular removable partial denture with OT Cap attachment
Arm Title
Comparator
Arm Type
No Intervention
Arm Description
Mandibular removable partial denture with gingival approaching clasp assembly
Intervention Type
Device
Intervention Name(s)
OT Cap attachment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oral Health Related Quality of Life
Description
Questionnaire
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Biting force
Description
i-load Star Sensor
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rania M. Hassan, MSC
Phone
(+02) 010 018 05207
Ext
(+02) 24041357
Email
rtmohamza2004@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yousr M. Mady, Professor
Organizational Affiliation
Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed M. Fayyad, A. Professor
Organizational Affiliation
Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Oral and Dental Medicine, Cairo University
City
Cairo
ZIP/Postal Code
11553
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yousr M. Mady, Professor
Phone
(+02)01006453846
Email
Yusrmady@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Treatment Outcomes After Receiving Conventional Clasp or Precision Attachment Removable Partial Dentures.

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