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

NCT06148727 | Completed

• 1 other identifier: A20011122
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Satisfaction

Outcome Measures

Primary Outcomes (2)

• 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).

Study Arms (2)

Conventional heat cured overdenture group

ACTIVE COMPARATOR

patients received 4 interforamenal implants connected by 3 bar assembly and conventional heat cured overdenture (Control Group)

Device: Dental implant placement; Device: Bar attachment

3d- printed overdenture group

ACTIVE COMPARATOR

patients received 4 interforamenal implants connected by 3 bar assembly and 3d printed overdenture (Study Group)

Device: Dental implant placement; Device: Bar attachment

Interventions

Dental implant placement DEVICE

Procedure/ surgery: Surgical placement of dental implants, four interforaminal dental implants were placed

3d- printed overdenture group; Conventional heat cured overdenture group

Bar attachment DEVICE

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

3d- printed overdenture group; Conventional heat cured overdenture group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University, Faculty of dentistry

Al Mansurah, Egypt

Location

Related Publications (1)

• Nabil MS, Mahanna FF, Said MM. Evaluation of masticatory performance and patient satisfaction for conventional and 3D-printed implant overdentures: a randomized crossover study. BMC Oral Health. 2024 Jun 8;24(1):672. doi: 10.1186/s12903-024-04389-1.

  PMID: 38851676 DERIVED

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Mohamed Shady, MD

  Mansoura University Faculty of Dentistry, Prosthodontics department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The succession of complete denture insertion was randomized to diminish the effect of the order of complete denture use on the results.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Each patient received two prostheses; conventional and 3D-printed implant overdentures. The succession of complete denture insertion was randomized to diminish the effect of the order of complete denture use on the results. First, each denture was used for three months, followed by two weeks of rest; then, the other denture type was delivered to the patient and used for another three months.

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: November 28, 2023
• Study Start: January 14, 2023
• Primary Completion: July 30, 2023
• Study Completion: August 10, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)