Evaluation of Masticatory Performance and Patient Satisfaction for Conventional and 3D Printed Implant Overdentures

The aim of this crossover clinical study was the evaluation and comparison of masticatory performance and patient satisfaction for patients rehabilitated with conventional heat cured acrylic resin and 3D printed mandibular implant overdentures retained with bar attachment.

it was concluded that 3D printed implant overdenture showed promising results regarding chewing efficiency and patient satisfaction compared to conventionally fabricated implant overdenture.

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction
• Intervention / Treatment: Device: Dental implant placement; Device: Bar attachment

Detailed Description

The aim of this crossover clinical study was the evaluation and comparison of masticatory performance and patient satisfaction for patients rehabilitated with conventional heat cured acrylic resin and 3D printed mandibular implant overdentures retained with bar attachment.

Materials and Methods: Twelve completely edentulous healthy participants received new conventional dentures. Four interforaminal implants were inserted in the mandible. After osseointegration, bar was constructed with trapezoidal configuration. Each patient received randomly the following overdentures using a crossover design: conventional heat cured acrylic resin overdenture, 3d printed overdenture ( developed by scanning of mandibular conventional overdenture). Masticatory performance was evaluated with the two-colour mixing ability test after 5, 10, 20, 30, and 50 masticatory cycles. Patient satisfaction was also measured using McGill Denture Satisfaction Questionnaire. Evaluation was done after 3 months of using each overdenture.

Conclusion: Within this clinical study limitations, 3D printed implant overdenture showed promising results regarding chewing efficiency and patient satisfaction compared to conventionally fabricated implant overdenture.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Mansoura University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• adequate bone quantity [classes 1-3 according to [Lekholm and Zarb] of the mandible in the lateral incisor and first premolar regions to receive 4 implants
• adequate restorative space [12-15 mm from the mucosa of the mandibular ridge to the occlusal plane- Class I according to Ahuja and Cagna 23 for bar supported implant overdenture. This was verified by direct measurement of old denture
• Angel's class I maxillo-mandibular relationship.

Exclusion Criteria:

• include systemic diseases that contraindicate implant placement
• irradiation of the head and neck region
• chemotherapy within the past 3 years
• bone metabolic diseases as uncontrolled diabetes mellitus
• smoking habit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional heat cured overdenture group; patients received 4 interforamenal implants connected by 3 bar assembly and conventional heat cured overdenture (Control Group)	Device: Dental implant placement; Procedure/ surgery: Surgical placement of dental implants, four interforaminal dental implants were placed; Device: Bar attachment; Device: attachment, implants were connected to each others by 3 implant assembly in a trapezoidal design implants were loaded after 3 months of osseo-integration Control Group: patients received coventionally constructed heat cured overdenture Study Group: patients received 3d printed overdenture
Active Comparator: 3d- printed overdenture group; patients received 4 interforamenal implants connected by 3 bar assembly and 3d printed overdenture (Study Group)	Device: Dental implant placement; Procedure/ surgery: Surgical placement of dental implants, four interforaminal dental implants were placed; Device: Bar attachment; Device: attachment, implants were connected to each others by 3 implant assembly in a trapezoidal design implants were loaded after 3 months of osseo-integration Control Group: patients received coventionally constructed heat cured overdenture Study Group: patients received 3d printed overdenture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chewing efficiency	Chewing efficiency was assessed using the previously documented two-color mixing ability test (colorimetric method) as follow: Two samples were prepared from two colored chewing gums. Patients were asked to keep the gum sample intraorally for one minute then start to chew it for 5, 10, 20, 30 and 50 strokes respectively. Five samples were used for the tests, the samples were spat into clear plastic bags. All samples were evaluated after flattening to wafers of 1 mm thickness. scanned by Digital scanner from both sides stored in Adobe Photoshop® format (psd). Then the color range tool and histogram function were used to pick out the unmixed white parts of the image. Then the ratio of Unmixed Fraction (UF) was computed using the following formula: (Pixels white side a + Pixels white side b) - 2× Pixels of scale / 2 × Pixels all. As a reference scale, a scanned piece of unmixed gum was copied in each image	at time of insertion of prosthesis T(0), 3 months after insertion T(3).
Patient satisfaction	The eight core of McGill Denture Satisfaction Questionnaire (MDSQ) items were used to record patient satisfaction with their mandibular complete removable denture. One question concerns overall satisfaction with existing prostheses, whereas the other seven questions refer to specific aspects that may influence overall satisfaction: ease of cleaning; ability to speak; comfort; aesthetics/appearance; and denture stability; chewing ability; chewing function. Respondents provided answers on a 100-mm visual analogue scale. Patients were encouraged to respond to the survey questionnaire after functioning with each type of denture for 3-months.	at time of insertion of prosthesis T(0), 3 months after insertion T(3).

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Mohamed Shady, MD, Mansoura University Faculty of Dentistry, Prosthodontics department

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2023
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: November 19, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: A20011122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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