Patient Satisfaction and OHRQoL In Removable Versus Fixed Implant Prostheses

NCT04694209 | Completed

• 1 other identifier: 151017
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives to evaluate the oral health-related quality of life and patient satisfaction in completely edentulous patients, when restored by maxillary and mandibular fixed (screw-retained) or removable telescopic retained implant supported prosthesis. 19 patients were randomized to receive either a fixed or a removable maxillary and mandibular full arch implant prosthesis. They were then asked to answer the OHIP-14 and a patient satisfaction questionnaire at 2 weeks, 3, 6 and 12 months post-prosthetic insertion.

Conditions

Completely Edentulous Patients

Outcome Measures

Primary Outcomes (1)

• patient satisfaction

  questionnaire. The patient satisfaction questionnaire is composed of 14 questions concerned with esthetics, speech, mastication, operative and prosthetic procedures, incidence of complications, pre-operative instructions, total time interval, cost, operator, hygienic procedures, overall experience as well as the willingness to repeat or refer others for the procedure.

  2 weeks after prosthetic insertion- 1 year

Secondary Outcomes (1)

• oral health related quality of life

  2 weeks after prosthetic insertion- 1 year

Study Arms (2)

Fixed implant supported prosthesis

EXPERIMENTAL

the prosthesis is an all-on-four prosthesis composed of a hybrid prosthesis. a metal framework, acrylic resin denture base and acrylic resin teeth

Procedure: maxillary and mandibular screw retained hybrid prostheses supported by 4 implants

Removable implant supported prosthesis

ACTIVE COMPARATOR

the prosthesis is an all-on-four prosthesis composed of a telescopic retained overdenture, both primary and secondary copings are custom made. the secondary copings are conncetd via a metal framework

Procedure: maxillary and mandibular telescopic retained overdentures supported by 4 implants

Interventions

maxillary and mandibular telescopic retained overdentures supported by 4 implants PROCEDURE

The wax of the trial denture was converted into heat-cured acrylic resin using conventional packing and flasking techniques. The prosthesis was finished, polished and screwed in the patient's mouth. Engaging (Internal hex) cylindrical, plastic patterns (Octa plastic cylinder, multi unit abutment, Red, Dentis, Daegu -Korea) were used to construct the primary copings of the telescopic prosthesis.The finished primary copings were scanned using a lab scanner (Shera Echo-scan 7. Dental Wings, Montreal-Canada). This was necessary to design and to mill the wax pattern of the secondary copings using CAD/CAM technology (Dental Wings Software, Dental Wings, Montreal -Canada). Secondary coping was designed to properly fit to the primary coping. The framework was then tried in. At that time it was ready for its intra-oral luting to the secondary copings.

Removable implant supported prosthesis

maxillary and mandibular screw retained hybrid prostheses supported by 4 implants PROCEDURE

Framework of the hybrid prosthesis is waxed using plastic copings attached to multiunit abutments. once the framework is finished , bite is recorded, teeth are set up and the waxed up prosthesis are tried in. IF accepted the wax is eliminated the wax up denture is converted inti heat cured acrylic resin

Fixed implant supported prosthesis

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completely edentulous male patients with an age range from 40- 70 years.
• Patients with a HbA1c equal to or less than 7
• All patients should have normal maxillo-mandibular relationship (Angle class I).
• Patients should have maxillary and mandibular ridges at least 7mm in width and 13 mm in height in the interforaminal areas and in the esthetic zones (premolar to premolar regions), respectively. This accommodated a pre-planned implant size of 3.7mm x 10 or 11mm.
• The maxillary and mandibular ridges should be covered by keratinized attached mucosa at least 5mm in width.
• An interarch space between the edentulous maxillary and mandibular ridges should not be less than 22 mm to accommodate the planned maxillary and mandibular implant-supported prostheses. This was confirmed by mounted diagnostic casts.
• Patients who were cooperative and who were psychologically and mentally stable as revealed from the initial interview with the patients were considered eligible.

You may not qualify if:

• Females were excluded on purpose to prevent failures associated with osteoporosis and to avoid gender variability which definitely affects the results of patient satisfaction and OHIP.
• \. Patients requiring hard or, soft tissue grafting of the proposed implant sites.
• \. Heavy smokers (more than 10 cigarettes / day) or patients with para-functional habits like clenching or bruxism were excluded. This was important to decrease the risk of implant failure.
• \. Patients with temporo-mandibular joint disorders were considered ineligible because of the expected occlusal disturbances.
• \. Patients with systemic disease that might contra-indicate implants placement or affect osseointegration e.g. uncontrolled diabetes.
• \. Patients who took chemo-or radiotherapy or any drug that might counter-affect the healing process or the quality of bone.

Sponsors & Collaborators

• Iman Abd-ElWahab Radi, PhD: lead

Study Sites (1)

Faculty of dentistry

Cairo, Manial, 12911, Egypt

Location

Study Officials

• Amira kheidr, masters

  Cairo University

  PRINCIPAL INVESTIGATOR

• Amr El Khadem, phd

  Cairo University

  STUDY DIRECTOR

• Samira Ibrahim, phd

  Cairo University

  STUDY CHAIR

• Iman Radi, phd

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor of prosthodontics

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: January 5, 2021
• Study Start: November 1, 2017
• Primary Completion: September 30, 2018
• Study Completion: August 28, 2019
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)