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

Phase 3

Completed

• Conditions: Periodontal Diseases
• Interventions: Biological: Acetal resin

• Registration Number: NCT06882161
• Lead Sponsor: Al-Azhar University

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.

Detailed Description

This study was a parallel, two-group, double-blinded, randomized clinical trial. The proposal and consents were approved by the Research Ethics Committee. (REC) approval (P-PD-14-14). The Helsinki Declaration's guiding principles were followed when conducting the study. The Comprehensive Standards of Reporting Trials Statement (CONSORT) checklist's structure is followed in the study's presentation. The study was carried out at the Outpatient Clinic of the Removable Prosthodontic Department within the Faculty of Dental Medicine for Girls at Al-Azhar University.

In this study, fifty patients were initially evaluated. After conducting clinical and radiographic assessments, twenty patients who satisfied the inclusion criteria were selected in accordance with the sample size calculation. Each patient received an explanation of every procedure, and informed consent was obtained. These twenty individuals were subsequently divided randomly into two distinct groups (ten in each):

Group I: Ten patients received polyoxymethylene (acetal resin) partial dentures designed and fabricated using CAD/CAM technology. Group II: Ten patients received polyether ether ketone (PEEK) partial dentures designed and fabricated using CAD/CAM technology.

All patients were evaluated clinically and radiographically. Clinical assessments were conducted by assessing the pocket depth (PD), plaque index (PI), and gingival index (GI) at denture insertion, three months later and six months later. Cone beam computed tomography (CBCT) was used to assess abutment alveolar bone height change at the time of denture placement, after three months, and after six months.

Study Timeline

• Study Start: 2024-05-15
• Primary Completion: 2024-11-23
• Study Completion: 2024-12-17
• Status Verified: 2025-03
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetal resin partial dentures	Acetal resin	ten patients received acetal resin partial dentures designed and fabricated using CAD/CAM technology
PEEK partial dentures	Acetal resin	ten patients received polyether ether ketone (PEEK) partial dentures designed and fabricated using CAD/CAM technology.

Primary Outcome Measures

Name	Time	Method
Pocket Depth	6 months	assessing the pocket depth (PD) of abutment teeth

Secondary Outcome Measures

Name	Time	Method
Plaque index	6 months	assessing the plaque index (PI) of abutment teeth
Gingival index	6 months	assessing the gingival index (GI) of abutment teeth
Abutment alveolar bone height change.	6 months	assessing the Abutment alveolar bone height of abutment teeth

Trial Locations

Locations (1)

Al-Azhar University; 🇪🇬 Cairo, Nasr City, Egypt