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

M

Minia University

Status

Completed

Conditions

Dental

Treatments

Other: Bar overdenture

Study type

Interventional

Funder types

Other

Identifiers

NCT06401187
644
shaimaa Radwan (Other Identifier)
Amr Esmail (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 3 patient groups

Co-Cr conventional technique cast bar attachments
Active Comparator group
Description:
conventional technique cast bar attachments
Treatment:
Other: Bar overdenture
Co-Cr CAD/CAM milled bar attachments
Experimental group
Description:
Co-Cr CAD/CAM milled bar attachments
Treatment:
Other: Bar overdenture
Co-Cr CAD/CAM 3D bar attachments
Experimental group
Description:
Co-Cr CAD/CAM 3D bar attachments
Treatment:
Other: Bar overdenture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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