Patient Satisfaction and Maximum Biting Force in Co-Cr Bar Implant Overdenture (bar)

Evaluation of Patient Satisfaction and Maximum Biting Force of Three Different Constructed Bars in Implant Overdenture in One Year Follow-up

Statement of problem. Patient satisfaction and maximum biting force from patients who wear 2-implant-retained overdentures with different constructed bar attachments can be improved.

Purpose. This randomised controlled clinical trial assessed patient satisfaction and maximum biting force with three differently constructed bar-retained overdentures (conventional casting, Milling and 3D printing CAD/CAM techniques) within a one-year follow-up.

Material and methods. A total of 60 implants were placed in 30 mandibular jaws(30 participants). The jaws were randomly assigned to 1 of the 3 treatment groups: a 10 conventional technique cast Co-Cr bar attachment, a 10 Co-Cr CAD/CAM milled bar attachment, and a 10 Co-Cr CAD/CAM 3D-printed bar attachment all groups were connected to 2 implants in the canine area. Patient satisfaction was tested after 6 months, and 12 months for each group; the results were collected, tabulated, and statistically analysed using a Pair-wise comparisons test and the Kruskal-Wallis test. Maximum biting force was tested at baseline,3 months, 6 months, and 12 months for each group; the results were collected, tabulated, and statistically analysed using a Pair-wise comparisons test and ANOVA test.

Study Overview

• Status: Completed
• Conditions: Dental
• Intervention / Treatment: Other: Bar overdenture

Detailed Description

A total of 60 implants were placed in 30 mandibular jaws(30 participants). The jaws were randomly assigned to 1 of the 3 treatment groups: a 10 conventional technique cast Co-Cr bar attachment, a 10 Co-Cr CAD/CAM milled bar attachment, and a 10 Co-Cr CAD/CAM 3D-printed bar attachment all groups were connected to 2 implants in the canine area. Patient satisfaction was tested after 6 months, and 12 months for each group; the results were collected, tabulated, and statistically analysed using a Pair-wise comparisons test and the Kruskal-Wallis test. Maximum biting force was tested at baseline,3 months, 6 months, and 12 months for each group; the results were collected, tabulated, and statistically analysed using a Pair-wise comparisons test and ANOVA test.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minia
    • Minya, Minia, Egypt, 61511
      • Minia university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with sufficient residual alveolar bone quantity and quality anterior to the mental foramen to receive self-taping root form titanium implants.
2. Maxillary and Mandibular residual alveolar ridges covered with healthy mucosa without any remaining roots or local inflammation.
3. Patients with sufficient inter-arch space (at least 15 mm) to have overdenture and bar attachment.
4. U-shaped lower ridge to avoid the lingual placement of the bar that occurs with a V-shaped ridge.
5. Patients with skeletal and dental class I.

Exclusion Criteria:

1. Patients with systemic diseases such as cardiovascular diseases, any disease of immunity, febrile conditions such as epilepsy, metabolic disorders, osteoporosis, hyperparathyroidism, and impaired psychological conditions that might affect the oral tissues or the bone metabolic rate.
2. Patients with local and general contraindications for surgical procedures.
3. Patients with TMJ or neuromuscular disorder.
4. Patients with Para functional habits such as bruxism and clenching.
5. Patients with impacted teeth or remaining roots.
6. Alcoholic patients.
7. Patients with a history of radiotherapy in the head and neck region.
8. Non-cooperative patients.
9. Patients with a history of bisphosphonate intake.
10. Patients with flabby tissues, bony undercuts, sharp bony edges, thin ridges or abnormalities at the lower alveolar ridge and recent extraction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Co-Cr conventional technique cast bar attachments; conventional technique cast bar attachments	Other: Bar overdenture; use of bar attachments as retentive mean of denture; Other Names: bar overdenture implants
Experimental: Co-Cr CAD/CAM milled bar attachments	Other: Bar overdenture; use of bar attachments as retentive mean of denture; Other Names: bar overdenture implants
Experimental: Co-Cr CAD/CAM 3D bar attachments	Other: Bar overdenture; use of bar attachments as retentive mean of denture; Other Names: bar overdenture implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	questionnaire	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximum biting force	occlusal force meter	1 year

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Study Chair: Amr E Badr, phd, Professor

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): January 17, 2024

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Patient satisfaction; 3D printed; Milled; implants,
• Other Study ID Numbers: 644; Amr Esmail (Other Identifier: minia university); shaimaa Radwan (Other Identifier: Minia UNiversity)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This randomised controlled clinical trial assessed patient satisfaction and maximum biting force with three differently constructed bar-retained overdentures (conventional casting, Milling and 3D printing CAD/CAM techniques) within a one-year follow-up.

Drug and device information, study documents

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