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

Not Applicable

Completed

• Conditions: Patient Satisfaction
• Interventions: Device: Dental implant placement; Device: Bar attachment

• Registration Number: NCT06148727
• Lead Sponsor: Mansoura University

Brief Summary

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.

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 Timeline

• Study Start: 2023-01-14
• Primary Completion: 2023-07-30
• Study Completion: 2023-08-10
• Study First Submitted: 2023-08-16
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-19
• Last Update Submitted: 2023-11-19
• Study First Posted: 2023-11-28
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conventional heat cured overdenture group	Dental implant placement	patients received 4 interforamenal implants connected by 3 bar assembly and conventional heat cured overdenture (Control Group)
3d- printed overdenture group	Dental implant placement	patients received 4 interforamenal implants connected by 3 bar assembly and 3d printed overdenture (Study Group)
3d- printed overdenture group	Bar attachment	patients received 4 interforamenal implants connected by 3 bar assembly and 3d printed overdenture (Study Group)
Conventional heat cured overdenture group	Bar attachment	patients received 4 interforamenal implants connected by 3 bar assembly and conventional heat cured overdenture (Control Group)

Primary Outcome Measures

Name	Time	Method
Chewing efficiency	at time of insertion of prosthesis T(0), 3 months after insertion T(3).	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
Patient satisfaction	at time of insertion of prosthesis T(0), 3 months after insertion T(3).	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.

Trial Locations

Locations (1)

Mansoura University, Faculty of dentistry; 🇪🇬 Mansoura, Egypt