Clinical trial NCT04032223: Patient Satisfaction and Retention in Implant Supported Telescopic Overdenture With Different Copings
Official title: Patient Satisfaction and Retention in Cast Metal Versus 3D Printed Metal Copings in Implant Supported Mandibular Telescopic Overdenture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Implant Supported Telescopic Overdenture
Keywords: 3D printed coping , overdenture, Implant , cast metal
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is Randomized Controlled Trial
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Patient Satisfaction
timeFrame: 3 months
Secondary outcomes:
measure: Retention
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Yusr O Mady, PHD
role: STUDY_CHAIR
affiliation: Cairo University
name: Nancy N Elsherbini, PHD
role: STUDY_CHAIR
References:
citation: 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.