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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2023-04-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Edentulous Jaw

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

completely edentulous mandibular arch opposing natural dentition were selected

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

each participant enrolled in the study randomly and the results of both groups were serialized and assessed by the outcome assessor

Study Groups

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group I (control)

The bars are fabricated from titanium. the participants received implant supported hybrid prosthesis with CAD/CAM fabricated titanium bars

Group Type ACTIVE_COMPARATOR

implant placement

Intervention Type PROCEDURE

All patients received four implants in the lower arch

group II

The bars are fabricated from PEEK . the participants received implant supported hybrid prosthesis with CAD/CAM fabricated PEEK bars

Group Type EXPERIMENTAL

implant placement

Intervention Type PROCEDURE

All patients received four implants in the lower arch

Interventions

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implant placement

All patients received four implants in the lower arch

Intervention Type PROCEDURE

Eligibility Criteria

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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 Ӏ 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

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes