Polyetheretherketone vs Cobalt-chromium Telescopic Removable Partial Denture in Kennedy Class I Patients Regarding Oral Health Related Quality of Life
Primary Purpose
Partially Edentulous Mandible
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
peek telescopic partial denture
Sponsored by
About this trial
This is an interventional treatment trial for Partially Edentulous Mandible
Eligibility Criteria
Inclusion Criteria:
- - Kennedy Class I Partially edentulous patients.
- Patients with good oral hygiene.
- The distal abutment bilaterally should be a premolar.
- Abutment teeth should be in a good periodontal condition.
- Sufficient inter-arch space, any super-eruptions should be treated before beginning of treatment.
- There should be no modifications spaces in the arch to be treated, and if found it should be treated with a fixed partial denture first.
- Normal tongue size
- Medically free from any disease that might affect bone support
- Patients with no history of bad oral habits as (Bruxism or Clenching) and free from any T.M.J disorders.
Exclusion Criteria:
- Patients with bad oral hygiene.
- Teeth with severe malalignment.
- The arch to be treated is opposed by a completely edentulous arch.
- Unmotivated patient.
- Patient with a medical disease that will hinder his ability to be committed to the treatment.
- Patients on a radiation therapy.
- Patients with xerostomia.
- Patients with a history of drug, alcohol abuse or psychiatric disorder.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Co-cr telescopic partial denture
PEEK telescopic partial denture
Arm Description
A removable partial denture, that gains retention from a telescopic crown made of cobalt chromium
A removable partial denture, its attachment is a telescopic crown made of PEEK
Outcomes
Primary Outcome Measures
oral health impact profile
questionnaire
Secondary Outcome Measures
probing depth of abutment teeth
using williams graduated probe
abutment mobility
millers classification
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03771248
Brief Title
Polyetheretherketone vs Cobalt-chromium Telescopic Removable Partial Denture in Kennedy Class I Patients Regarding Oral Health Related Quality of Life
Official Title
A Comparison Between Polyetheretherketone and Cobalt-chromium Telescopic Removable Partial Denture in Kennedy Class I Partially Edentulous Patients Regarding Oral Health Related Quality of Life (A Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Dentistry is a rapidly progressing field with innumerable advances taking place on a day to day basis. The application of newer technologies and materials has advanced the specialty of prosthodontics and the services rendered to the patients.
Taking into consideration that PEEK as a material wasn't clinically investigated to be used as a material for routine use, however PEEK in removable partial dentures will help in making many steps easier and reach patients demands regarding esthetics. Also, owing to the superior mechanical and biological properties of PEEK, it will not be surprising if dentures constructed from the polymer are routinely constructed in near future.
Detailed Description
On fabrication of telescopic removable partial denture, choosing the material is a major step in the success of the treatment. There are different aspects that should be taken into consideration while choosing it. Beginning with retention as it is a crucial aspect. The retention of the telescopic partial denture is gained from the friction between the primary and secondary crowns. The chosen material should be able to maintain this type of retention for the longest possible period.
The esthetics also affects the treatment choice and patients preference, patients would choose metal free restorations over the ones that display metal. Finally the load distribution between the residual ridge and abutment should be equalized and transmitted in a favorable way. Otherwise one of the following consequences will occur; either overload on the abutment teeth followed by bone loss and abutment mobility or this overload is on the residual ridge leading to fast, progressive bone loss.
Cobalt chromium that is used for fabricating the telescopic removable partial denture is considered that most suitable material up till this moment. However, it doesn't fulfill much of the previous points.
As there will always be a continued improvement of materials and techniques used in dentistry especially in prosthodontics, innovative techniques must be regarded as potential alternatives to traditional materials.
PEEK is from the innovative materials that has shown promising results in different branches. However, to date no clinical studies or systematic reviews focusing on the use of PEEK dentures have been published, therefore more investigations are needed in this field.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partially Edentulous Mandible
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Co-cr telescopic partial denture
Arm Type
Active Comparator
Arm Description
A removable partial denture, that gains retention from a telescopic crown made of cobalt chromium
Arm Title
PEEK telescopic partial denture
Arm Type
Experimental
Arm Description
A removable partial denture, its attachment is a telescopic crown made of PEEK
Intervention Type
Device
Intervention Name(s)
peek telescopic partial denture
Intervention Description
removable partial denture
Primary Outcome Measure Information:
Title
oral health impact profile
Description
questionnaire
Time Frame
12 months
Secondary Outcome Measure Information:
Title
probing depth of abutment teeth
Description
using williams graduated probe
Time Frame
12 months
Title
abutment mobility
Description
millers classification
Time Frame
12 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Kennedy Class I Partially edentulous patients.
Patients with good oral hygiene.
The distal abutment bilaterally should be a premolar.
Abutment teeth should be in a good periodontal condition.
Sufficient inter-arch space, any super-eruptions should be treated before beginning of treatment.
There should be no modifications spaces in the arch to be treated, and if found it should be treated with a fixed partial denture first.
Normal tongue size
Medically free from any disease that might affect bone support
Patients with no history of bad oral habits as (Bruxism or Clenching) and free from any T.M.J disorders.
Exclusion Criteria:
Patients with bad oral hygiene.
Teeth with severe malalignment.
The arch to be treated is opposed by a completely edentulous arch.
Unmotivated patient.
Patient with a medical disease that will hinder his ability to be committed to the treatment.
Patients on a radiation therapy.
Patients with xerostomia.
Patients with a history of drug, alcohol abuse or psychiatric disorder.
12. IPD Sharing Statement
Learn more about this trial
Polyetheretherketone vs Cobalt-chromium Telescopic Removable Partial Denture in Kennedy Class I Patients Regarding Oral Health Related Quality of Life
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