Clinical and Radiographic Evaluation of The Effect of Acetal Resin Versus PEEK on Supporting Structure of Abutment Teeth

NCT06882161 | Completed Phase 3

• 1 other identifier: P-PD-14-14
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to evaluate and compare the effect of acetal resin versus Polyether ether ketone (PEEK) partial dentures on abutment teeth supporting structures in Kennedy class I mandibular partial denture cases. Clinical assessments were conducted by assessing the pocket depth (PD), plaque index (PI), and gingival index (GI). Cone beam computed tomography (CBCT) was used to assess abutment alveolar bone height change.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• Pocket Depth

  assessing the pocket depth (PD) of abutment teeth

  6 months

Secondary Outcomes (3)

• Plaque index

  6 months

• Gingival index

  6 months

• Abutment alveolar bone height change.

  6 months

Study Arms (2)

Acetal resin partial dentures

ACTIVE COMPARATOR

ten patients received acetal resin partial dentures designed and fabricated using CAD/CAM technology

Biological: Acetal resin

PEEK partial dentures

ACTIVE COMPARATOR

ten patients received polyether ether ketone (PEEK) partial dentures designed and fabricated using CAD/CAM technology.

Biological: Acetal resin

Interventions

Acetal resin BIOLOGICAL

Effect of acetal resin versus Polyether ether ketone (PEEK) partial dentures on abutment teeth supporting structures in Kennedy class I mandibular partial denture cases

Also known as: PEEK

Acetal resin partial dentures; PEEK partial dentures

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Every subject should be free of any systemic diseases that might influence the results of the research.
• Patient's residual ridges should be covered with healthy mucosa.
• Their salivary flow and viscosity for all within normal limits.
• The patients are cooperative and ready to be called back as necessary.
• had a Class I Angle's ridge relation

You may not qualify if:

• Alcoholic or smokers' patients.
• Patients with xerostomia or excessive salivation.
• Patients with parafunctional habits.
• Patients with ulcerated or inflamed mucosa.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University

Cairo, Nasr City, 19519, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

acetalic resin, Acetal-Dental; polyetheretherketone

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Yasmin S Zidan, PhD

  Lecturer at faculty of dental medicine for girls , Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: (patients and assessors)
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Yasmin S. Zidan

Model Details: This study was a parallel, two-group, double-blinded, randomized clinical trial.

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 18, 2025
• Study Start: May 15, 2024
• Primary Completion: November 23, 2024
• Study Completion: December 17, 2024
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)