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

NCT06401187 | Completed

• 3 other identifiers: 644Amr Esmailshaimaa Radwan
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental

Keywords

implants,; Milled; 3D printed; Patient satisfaction

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction

  questionnaire

  1 year

Secondary Outcomes (1)

• maximum biting force

  1 year

Study Arms (3)

Co-Cr conventional technique cast bar attachments

ACTIVE COMPARATOR

conventional technique cast bar attachments

Other: Bar overdenture

Co-Cr CAD/CAM milled bar attachments

EXPERIMENTAL

Co-Cr CAD/CAM milled bar attachments

Other: Bar overdenture

Co-Cr CAD/CAM 3D bar attachments

EXPERIMENTAL

Co-Cr CAD/CAM 3D bar attachments

Other: Bar overdenture

Interventions

Bar overdenture OTHER

use of bar attachments as retentive mean of denture

Also known as: bar overdenture implants

Co-Cr CAD/CAM 3D bar attachments; Co-Cr CAD/CAM milled bar attachments; Co-Cr conventional technique cast bar attachments

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Patients with local and general contraindications for surgical procedures.
• Patients with TMJ or neuromuscular disorder.
• Patients with Para functional habits such as bruxism and clenching.
• Patients with impacted teeth or remaining roots.
• Alcoholic patients.
• Patients with a history of radiotherapy in the head and neck region.
• Non-cooperative patients.
• Patients with a history of bisphosphonate intake.
• Patients with flabby tissues, bony undercuts, sharp bony edges, thin ridges or abnormalities at the lower alveolar ridge and recent extraction.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University

Minya, Minya Governorate, 61511, Egypt

Location

Related Publications (1)

• Badr AMI, Nabawy M, Mohammed GF, Radwan SA. Evaluation of patient satisfaction and maximum biting force of three differently constructed bars on two implants retaining mandibular overdenture - one year follow-up (a randomized controlled clinical trial). BMC Oral Health. 2024 Nov 9;24(1):1360. doi: 10.1186/s12903-024-05092-x.

  PMID: 39522003 DERIVED

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Amr E Badr, phd

  professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer assistant

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 6, 2024
• Study Start: November 10, 2022
• Primary Completion: December 15, 2023
• Study Completion: January 17, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)