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Completed

NCT Number: NCT06401187

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

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minia University

Minya, Minya Governorate, 61511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Bar overdenture

Other

use of bar attachments as retentive mean of denture

Other names: bar overdenture implants

Primary outcomes

  1. Patient Satisfaction

    Time frame: 1 year

    questionnaire

Secondary outcomes

  1. maximum biting force

    Time frame: 1 year

    occlusal force meter

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Acronym: bar

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 6, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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