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

Patient Satisfaction and Retention in Cast Metal Versus 3D Printed Metal Copings in Implant Supported Mandibular Telescopic Overdenture

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.

Study Overview

• Status: Unknown
• Conditions: Implant Supported Telescopic Overdenture
• Intervention / Treatment: Procedure: Implant placemet in the mandibular canine regions

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Metal copings different designs in implant supported telescopic overdenture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	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.	6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Yusr O Mady, PHD, Cairo University; Study Chair: Nancy N Elsherbini, PHD, Cairo University

Publications and helpful links

General Publications

• Yunus N, Saub R, Taiyeb Ali TB, Salleh NM, Baig MR. Patient-based and clinical outcomes of implant telescopic attachment-retained mandibular overdentures: a 1-year longitudinal prospective study. Int J Oral Maxillofac Implants. 2014 Sep-Oct;29(5):1149-56. doi: 10.11607/jomi.3328.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (Actual): July 25, 2019

Study Record Updates

• Last Update Posted (Actual): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: 3D printed coping , overdenture, Implant , cast metal
• Other Study ID Numbers: PRO305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: I will check with my study chair.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No