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

NCT06201169 | Completed DMC

• 1 other identifier: REC 02-21 4
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Edentulous Jaw

Keywords

Hybrid prosthesis, Polyether-ether-ketone,

Outcome Measures

Primary Outcomes (1)

• Radiographically (digital periapical)

  marginal bone loss around the implants

  six and twelve months

Study Arms (2)

group I (control)

ACTIVE COMPARATOR

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

Procedure: implant placement

group II

EXPERIMENTAL

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

Procedure: implant placement

Interventions

implant placement PROCEDURE

All patients received four implants in the lower arch

group I (control); group II

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amr Azab Abd El-Fattah: lead
• Tanta University: collaborator

Study Sites (2)

Faculty of dentistry tanta university

Al Gharbī Bahjūrah, Tanta, 31527, Egypt

Location

Tanta University

Al Gharbī Bahjūrah, Tanta, 31527, Egypt

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Research Ethics committee

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: each participant enrolled in the study randomly and the results of both groups were serialized and assessed by the outcome assessor
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assiatant lecturer

Model Details: completely edentulous mandibular arch opposing natural dentition were selected

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: January 11, 2024
• Study Start: April 15, 2021
• Primary Completion: May 20, 2022
• Study Completion: April 25, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)