Effect of Using (PEKK) Framework Versus (Co- Cr) Framework on The Bone of Mandibular Implant Supported Hybrid Prostheses

NCT06176014 | Completed DMC

• 1 other identifier: FDASU-RecID032134
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

the purposse of the study To evaluate the effect of implant supported hybrid prostheses on the bone of the supporting structure of edentulous mandible using Polyetherketoneketone (PEKK) framework versus cobalt chromium framework. fourteen female patients with lower single edentulous ridges are chosen with adequate dental hygiene, enough interarch space and free of systemic diseases and parafunctional habits. Patients who received new single dentures are randomly allocated into each group using computer software program and five intraforaminal implants were inserted parallel using surgical guide.

Conditions

Alveolar Bone Loss

Keywords

hybrid prosthesis; PEKK framework; PFM framework

Outcome Measures

Primary Outcomes (1)

• amount of bone loss around implant

  The points of first bone contact with the fixture platform were detected and changes of those points position through the two years of observation were registered as a criterion of bone changes with further calculation of average values. A software ruler of CBCT was used to measure the crestal bone height in contact with the implant from the four aspects (buccal, lingual, mesial and distal).

  2 years

Study Arms (2)

(PEKK fixed hybrid prostheses

OTHER

5 implants were placed in mandibular arch by surgical guide and after 3 months the prostheses was constructed by using digital workflow

Procedure: implant placement

PFM fixed hybrid prostheses

OTHER

5 implants were placed in mandibular arch by surgical guide and after 3 months the prostheses was constructed by using digital workflow until making wax pattern the casting was made.

Procedure: implant placement

Interventions

implant placement PROCEDURE

5 implant were placed in intraforaminal area using surgical guide

Also known as: final prostheses was made on 5 implants

(PEKK fixed hybrid prostheses; PFM fixed hybrid prostheses

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient's age range from 50 to 60 year's old.
• All patients are with completely edentulous mandible.
• Good oral hygiene is mandatory.
• Sufficient interarch space to accept implant supported fixed prosthesis will be diagnosed by mounted diagnostic casts.
• Firm and healthy mucosa covering the alveolar ridge.
• Minimum bone width 5.5mm buccolinguallly and 10 mm height will be diagnosed by the preoperative cone beam CT scan.

You may not qualify if:

• \- Vulnerable group; prisoners, mentally, physically disabled, pregnant females.
• Patients with Para functional habits.
• Patients having TMJ disorders.
• Uncontrolled diabetic patients
• Patients have any medical condition or any disease that could interfere with implant placement or affect bone loss.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Dalia Mohammed Farid

Cairo, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• dina essam bahig

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: all the selected patients were rehabilitated with lower single denture then divided by computer randomization using random allocation software
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: to compare PEKK framework for hybrid prostheses ( fixed detachable ) versus PFM framework

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 19, 2023
• Study Start: June 8, 2021
• Primary Completion: September 2, 2022
• Study Completion: September 2, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

EG (1)