PEEK Bar Versus Titanium Bar Fabricated by CAD-CAM in Mandibular Hybrid Prostheses: A Comparative Study

Edentulous Jaw Clinical Trial

Official title:

Comparative Study of PEEK Bar Versus Titanium Bar Fabricated by CAD-CAM in Mandibular Hybrid Prostheses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06201169
• Other study ID #: REC 02-21 4
• Status: Completed
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: April 25, 2023

Study information

• Verified date: January 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

CAD/CAM-fabricated PEEK bar exhibited greater dimensional deviation in comparison to its titanium counterpart. Nevertheless, patients with PEEK bars reported higher satisfaction levels and lower marginal bone loss when compared to those with titanium bars.

Description:

Fourteen patients with completely edentulous mandibular arch opposing natural dentition were selected and divided into two groups, seven patients in each. All patients received implant-supported hybrid prostheses with a bar fabricated by CAD/CAM milling technique. In group I (control), bar was fabricated from titanium, while in group ӀӀ, the bar was fabricated from PEEK. The evaluation of the study was done at 6 and 12 follow-up periods according to the following: 1- Experimentally by Geomagic (Geomagic, Japan) to detect any dimensional deviation of PEEK bars compared to titanium bars. 2-Clinically by questionnaire to evaluate the patient satisfaction. 3- Radiographically (digital periapical) to measure marginal bone loss around the implants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 25, 2023
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• Completely edentulous mandibular arch for at least six months have almost of the natural teeth in the maxillary arch with a ranged of age from 40- 60 years old. and normal class ? maxilla-mandibular relationship with a minimum 12-15 mm inter-arch space

Exclusion Criteria:

• All patient had systemic disorders that may influence soft or hard tissue healing were

excluded as:

• History of radiation therapy in the head and neck region.
• Active infection or inflammation or flabby tissue in the mandibular arch
• Bone diseases as osteoporosis.
• Clenching or bruxism, temporomandibular joint troubles
• Neurological or psychiatric handicap conditions that could interfere with good oral hygiene.
• Heavy smoking and drug abusing

Related Conditions & MeSH terms

• Edentulous Jaw
• Jaw, Edentulous

Intervention

Procedure:
• implant placement
All patients received four implants in the lower arch

Locations

Country	Name	City	State
Egypt	Faculty of dentistry tanta university	Al Gharbi Bahjurah	Tanta
Egypt	Tanta University	Al Gharbi Bahjurah	Tanta

Sponsors (2)

Lead Sponsor	Collaborator
Amr Azab Abd El-Fattah	Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographically (digital periapical)	marginal bone loss around the implants	six and twelve months