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

March 12, 2025 updated by: Yasmin Seif Eldeen Zidan, Al-Azhar University

Clinical and Radiographic Evaluation of The Effect of Acetal Resin Versus PEEK on Supporting Structure of Abutment Teeth in Mandibular Kennedy Class I Partial Dentures Manufactured by CAD-CAM Technology

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Nasr City
      • Cairo, Nasr City, Egypt, 19519
        • Al-Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Acetal resin partial dentures
ten patients received acetal resin partial dentures designed and fabricated using CAD/CAM technology
Biological: Acetal resin
Effect of acetal resin versus Polyether ether ketone (PEEK) partial dentures on abutment teeth supporting structures in Kennedy class I mandibular partial denture cases
Other Names:
  • PEEK
Active Comparator: PEEK partial dentures
ten patients received polyether ether ketone (PEEK) partial dentures designed and fabricated using CAD/CAM technology.
Biological: Acetal resin
Effect of acetal resin versus Polyether ether ketone (PEEK) partial dentures on abutment teeth supporting structures in Kennedy class I mandibular partial denture cases
Other Names:
  • PEEK

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pocket Depth
Time Frame: 6 months
assessing the pocket depth (PD) of abutment teeth
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plaque index
Time Frame: 6 months
assessing the plaque index (PI) of abutment teeth
6 months
Gingival index
Time Frame: 6 months
assessing the gingival index (GI) of abutment teeth
6 months
Abutment alveolar bone height change.
Time Frame: 6 months
assessing the Abutment alveolar bone height of abutment teeth
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Al-Azhar University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yasmin S Zidan, PhD, Lecturer at faculty of dental medicine for girls , Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 17, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P-PD-14-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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