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Patient Satisfaction and Retention in Implant Supported Telescopic Overdenture With Different Copings

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ClinicalTrials.gov Identifier: NCT04032223
Recruitment Status : Not yet recruiting
First Posted : July 25, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Amr Abdelmoez Abosabaa, Cairo University

Brief Summary:

Implant retained overdentures provided more satisfaction with regard to conventional denture related problems such as esthetics, speech, chewing, fit and retention, function and quality of life. Evaluation of patient satisfaction allows direct quantification of patients' opinions on different aspects of a given treatment.

Studies have indicated that conventional complete denture wearers rehabilitated with mandibular implant supported overdenture experience better retention and stability, improved overall function and satisfaction.

Patient satisfaction is one factor that influences the success of overdenture treatment(Naert, Alsaadi et al. 2004). Previous studies have shown a difference between patients' satisfaction with their dental prostheses and clinicians' assessments of patients' oral condition.(Emami, Heydecke et al. 2009).This indicates that clinical assessments of dentures are not valid predictors of patient satisfaction.

The two primary methods used to fabricate these restorations may be subtractive (milling and grinding) or additive manufacturing (Rapid Prototype, RP or 3D printing), The 3D printing technology has been incorporated into dentistry, but does not include ceramics and is limited to polymers.

3D printing by rapid prototyping has many advantages which are the availability of high production rate where the technician can easily produce over 150 units per hour. Also the quality control of wax copings which results in high precision fit and constant wall thickness. This will result in better stability and retention and consequently patient satisfaction. Finally is the reduced finishing work needed on cast copings. The irregularities in wax coping thickness can be avoided.


Condition or disease Intervention/treatment Phase
Implant Supported Telescopic Overdenture Procedure: Implant placemet in the mandibular canine regions Not Applicable

Detailed Description:

Cast metal coping is the comparator. Because of their parallel walled design, telescopic crowns provide horizontal stability, thus stabilizing the prosthesis against lateral dislodging forces. The overdenture's self finding mechanism in telescopic constructions facilitates prosthesis insertion considerably.

Telescopic constructions seem to be easy to care for as they do not possess areas of difficult access for maintenance. This is why this construction also seems to be an effective treatment modality for geriatric patients with serious systemic diseases, which affect the degree of dexterity.

Despite rapid development in overdenture attachments and implant-supported overdentures with cast metal copings remain a viable and usable modality in dental practice. There is limited clinical follow-up data of the complications associated with overdentures and abutment teeth restored with metal copings, including post-procedural and prosthetic problems.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: It is Randomized Controlled Trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patient Satisfaction and Retention in Cast Metal Versus 3D Printed Metal Copings in Implant Supported Mandibular Telescopic Overdenture
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : July 1, 2022

Arm Intervention/treatment
Experimental: 3D printed metal copings
3D printed primary and secondary metal copings inderctly from 3D printed resin in mandibular implant supported telescopic overdenture , Single Implants are placed in the interforaminal region bilaterally .
Procedure: Implant placemet in the mandibular canine regions
Implant placemet in the mandibular canine regions retained by cast metal copings or 3D printed metal copings to deliver Implant Supported telescopic overdenture in the mandible
Other Name: Metal copings different designs in implant supported telescopic overdenture

Active Comparator: Cast metal copings
Cast metal primary and secondary metal copings in mandibular implant supported telescopic overdenture , Single Implants are placed in the interforaminal region bilaterally .
Procedure: Implant placemet in the mandibular canine regions
Implant placemet in the mandibular canine regions retained by cast metal copings or 3D printed metal copings to deliver Implant Supported telescopic overdenture in the mandible
Other Name: Metal copings different designs in implant supported telescopic overdenture




Primary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: 3 months ]
    Patients will be recalled on their scheduled dates to the Prosthodontics department ,Faculty of Dentistry , Cairo University. The patient-based outcomes that will be used in this thesis included the variables measured on the 100-mm VAS (Visual Analogue Scale) and on Category Scales (CAT) that had been previously validated


Secondary Outcome Measures :
  1. Retention [ Time Frame: 6 months ]

    small perpendicular metal tubes were placed a few millimetres underneath the canines in the mandibular denture base.

    In this manner the denture could be rigidly and reproducibly connected to the retention-measuring device. Retention measuring device is a device that was developed to apply an increasing, vertical force on the denture The force was administered througha straight metal bar that was fitted withstrain gauges (Measurements Group Inc.,Raleigh, NC, USA). The bar was rigidly connected to the denture.




Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   patients are eligible for implant placment over 18 years
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients' age ranging from 45 -65 years old Patients are males or females Completely edentulous maxilla and mandible. Sufficient restorative space ( Not less than 12mm) Co-operative patient that should show motivation to follow up. Sufficient bone to receive Dental implant 3.7mm diameter and 10 mm length in the interforaminal region.

• Exclusion criteria: Patients having any bony undercuts. Patients having any disease affecting muscle coordination as Parkinsonism. Uncontrolled diabetic patients. Patients having limited mouth opening. Patients having bad oral hygiene.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032223


Contacts
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Contact: Ahmed M Abosabaa, MSC 00201128223399 aabosabaa@gmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Yusr O Mady, PHD Cairo University
Study Chair: Nancy N Elsherbini, PHD Cairo University

Publications:
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Responsible Party: Ahmed Mohamed Amr Abdelmoez Abosabaa, Teaching Assistant, Cairo University
ClinicalTrials.gov Identifier: NCT04032223    
Other Study ID Numbers: PRO305
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: I will check with my study chair.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Mohamed Amr Abdelmoez Abosabaa, Cairo University:
3D printed coping , overdenture, Implant , cast metal