Comparison of Patient Satisfaction and Chewing Efficiency Between Conventional and 3D Printed Complete Dentures.

NCT06103019 | Completed

• 1 other identifier: A04080120
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Twenty completely edentulous patients were enrolled in this study. Each patient received two types of prostheses. 1) Conventional complete dentures. 2) 3D printed dimethacrylate-based resin complete dentures. Patient satisfaction was assessed using the oral health impact profile (OHIP-EDENT-N) survey questionnaire, and masticatory performance was evaluated with the two-colored chewing gum mixing ability by evaluation of the standard deviation of hue at (T0) at the time of complete denture insertion, (T3) after 3 months of denture use and (T6) after 6 months of denture use.

Conditions

Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

  The Oral health-related quality of life (OHRQoL) of the patient was assessed using an instrument called OHIP-EDENT-N A simple score was calculated by adding the responses to all the questions (0 = never; 1= seldom; 2 = fairly often; 3 = often; 4 = very often)

  6 months

Secondary Outcomes (1)

• chewing efficiency

  6 months

Study Arms (2)

Conventional (complete denture)

ACTIVE COMPARATOR

Each patient received two prostheses: 1) Conventional Maxillary and mandibular complete denture. 2) 3D printed complete Maxillary and mandibular complete denture. The succession of complete denture insertion was randomized to reduce the impact of the order of the complete denture on patient satisfaction outcomes. Each denture was used for 3 months followed by 2 weeks rest period without wearing denture then the other type of denture was delivered and used for another 3 months.

Other: conventional complete denture; Other: 3D complete denture

3D printed complete denture

ACTIVE COMPARATOR

Each patient received two prostheses: 1) Conventional Maxillary and mandibular complete denture. 2) 3D printed complete Maxillary and mandibular complete denture. The succession of complete denture insertion was randomized to reduce the impact of the order of the complete denture on patient satisfaction outcomes. Each denture was used for 3 months followed by 2 weeks rest period without wearing denture then the other type of denture was delivered and used for another 3 months.

Other: conventional complete denture; Other: 3D complete denture

Interventions

conventional complete denture OTHER

conventional complete denture. The succession of complete denture insertion was randomized to reduce the impact of the order of the complete denture on patient satisfaction outcomes. Each denture was used for 3 months followed by 2 weeks rest period without wearing the denture then the other type of denture was delivered and used for another 3 months and vice versa.

3D printed complete denture; Conventional (complete denture)

3D complete denture OTHER

3D complete denture. The succession of complete denture insertion was randomized to reduce the impact of the order of the complete denture on patient satisfaction outcomes. Each denture was used for 3 months followed by 2 weeks rest period without wearing the denture then the other type of denture was delivered and used for another 3 months and vice versa.

3D printed complete denture; Conventional (complete denture)

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• They were healthy, free from any systemic diseases affecting bone metabolism such as uncontrolled diabetics or osteoporosis. This was achieved through detailed medical history and clinical examination by physician. They had no previous denture experience. Residual alveolar ridges covered with healthy firm mucosa. Angle's class I maxilla-mandibular relationship.

You may not qualify if:

• Systemic disease

Sponsors & Collaborators

• Fatma mahanna: lead

Study Sites (1)

Faculty of dentistry, mansoura university

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer of prosthodontics

Model Details: A crossover design was conducted. Each patient received two prostheses: 1) Conventional Maxillary and mandibular complete denture. 2) 3D printed Maxillary and mandibular complete denture.Each denture was used for 3 months followed by 2 weeks rest period without wearing the denture then the other type of denture was delivered and used for another 3 months.

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 26, 2023
• Study Start: December 15, 2020
• Primary Completion: June 20, 2022
• Study Completion: November 20, 2022
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)