Patient Satisfaction and Oral Healthy Related Quality of Life of Polyetherketoneketone and Metal Framework.

NCT05904756 | Unknown

• 1 other identifier: A0105023RP
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The patients' satisfaction and oral health related quality of life (OHRQL) of different framework material remains uncertain. Thus, the aim of this clinical cross over study was to compare patient satisfaction and OHRQL OF polyetherketoneketone and metal framework for All-on-four implant supported fixed prosthesis

Conditions

Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• The patients' satisfaction using a visual analog scale (VAS)

  VAS score include, comfort with prosthesis, ease of cleaning appearance, decreased embarrassment, ease of speaking, general satisfaction of mandibular prosthesis compared to teeth and prosthesis apart of you, and decreased embracing. Higher score indicating increase satisfaction, and lower scores indicating less satisfaction.

  1 year

Secondary Outcomes (1)

• Oral healthy related quality of life (OHRQoL)

  1 year

Study Arms (2)

Metal framework group

Two sets of patients were made (10 patients/set) using random-generated numbers created by a computer program (Excel sheet). Conventional complete denture will be fabricated first and patient will wear the denture for 3 months. Then 4 implants will be placed according to all in 4 concept.after 3 months of asseointegration,the first 10 participants will recieve metal framework first. After 3 months, patient satisfaction and oral healthy related quality of lifewill be measured.

Device: framework for implant supported prosthesis, fabricated from metal of polyetherketoneketone

PEKK framework group

metal framework will be replaced by PEKK framework. After another 3 months, measurements will be repeated. The second 10 patients received polyetherketoneketone first, and after 3 months, measurements will be made. Then, polyetherketoneketone framework will be replaced by Metal framework and measurements( Patient satisfaction and oral healty related quality of life) will be repeated after another 3 months in across over design.

Device: framework for implant supported prosthesis, fabricated from metal of polyetherketoneketone

Interventions

framework for implant supported prosthesis, fabricated from metal of polyetherketoneketone DEVICE

evaluation of patient satisfaction and oral healty related quality of life

Metal framework group; PEKK framework group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sample size calculation was based on difference in OHIP between CD \& MB groups retrived from previous research using 2-tailed test , α error =0.05 and power = 90.0% , the total calculated sample size will be 10 cases in each group.

You may qualify if:

• Sufficient available restorative space (from the proposed occlusal plane to soft tissue • covering residual ridge) of at least 20 mm to accommodate all types of tested prosthesis.
• They had completely edentulous maxilla and mandible at least six months after the last extraction.
• Sufficient residual alveolar ridge quantity and quality (D2-D3)
• Maxillary and mandibular residual alveolar ridges covered by healthy non-inflamed mucosa with even compressibility.
• Normal maxillo-mandibular relationship.

You may not qualify if:

• All diseases or syndromes are contraindicated with implant surgery such as:
• General contraindications for surgical procedures such as patients with head and neck radio therapy, patients with bleeding disorders, hepatic patients.
• Patients with metabolic disorders that affect Osseo integration such as diabetes mellitus, and osteoporosis.
• Long term immunosuppressive and corticosteroid drug therapy.
• Abnormal detrimental habits, e.g. bruxism and clenching.
• Heavy smokers and alcoholic patients.
• All patients will be informed about the steps involved in this research and they will sign a
• written consent form of the ethical committee of faculty of dentistry Mansoura University for approval to take part in this research and come to the follow up visits.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of dentistry , Mansoura University

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Mohammed E Sawy

  Mansoura University

  STUDY DIRECTOR

Central Study Contacts

Mohammed E Sawy, PhD

CONTACT

+201061314522; Dr_sawy@windowslive.com

Salah A Hegazy, PhD

CONTACT

01227690209; salahhegazy@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer, Department of prosthodontics, principle investigator

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: May 15, 2023
• Primary Completion: January 4, 2024
• Study Completion: May 15, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)