CClinicalTrials.gg
Status unknownNCT03777345Updated Dec 17, 2018

Comparison Between Injection Molded Polyetheretherketone (PEEK) Framework and Cobalt Chromium Framework Removable Partial Dentures Regarding Periodontal Health of Abutment Teeth

An interventional study of cobalt-chromium framework partial dentures and PEEK framework partial dentures in Mandibular Prosthesis User, sponsored by Cairo University. Status unknown at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2018-12-17.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Sex
All
01

Study summary

This study is aiming to evaluate the periodontal status of the abutment teeth in Polyetheretherketone ( PEEK ) framework partial dentures compared with cobalt-chromium ones in mandibular kennedy class I edentulous cases aiming to preserve the optimum periodontal health of the abutment teeth .

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Conditions studied

  • Mandibular Prosthesis User
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In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Kennedy Class I partially edentulous subjects indicated for framework partial denture

Exclusion criteria

Exclusion Criteria:

  • 1- uncooperative patients . 2- bad oral hygiene patients .
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    cobalt-chromium framework partial dentures

    It's the gold standard biocompatible metal alloy used in thin sections, provide high strength and stiffness ,conduct heat and cold for a more natural experience, and is resistant to corrosion but their disadvantages include esthetic issues with metal display, oral galvanism, adverse tissue reactions,and osteolysis of abutment teeth.

    Device: cobalt-chromium framework partial dentures

  • Experimental
    PEEK framework partial dentures

    It's a promising polymer-based framework has recently been introduced which is made of polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base.

    Device: PEEK framework partial dentures

Interventions

  • Devicecobalt-chromium framework partial dentures

    It's a biocompatible metal alloy used in thin sections and are less bulky, provide high strength and stiffness ,conduct heat and cold for a more natural experience, enable designs that minimize the covering of the gingival margins, allow for a stable denture base, and is resistant to corrosion. Disadvantages include hypersensitivity, esthetic issues with metal display, oral galvanism, adverse tissue reactions, osteolysis of abutment teeth, and biofilm production .

  • DevicePEEK framework partial dentures

    It's a promising polymer-based framework material has recently been introduced which is made of polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base.

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What researchers measure

Primary outcomes

  1. Periodontal status

    periodontal status of the abutment teeth assessed by a periodontal chart .

    Time frame: Change in periodontal status will be assessed at base line , after one month and after 3 months .

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Study locations

1 site
  • Faculty of Oral and Dental Medicine Cairo University
    Cairo, 11311, Egypt
    • Hassan Ahmed · Contact
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References and documents

Publications

  • Abdel-Bary SK, Rostom EM, Elboarey AN. Thermoplastic Removable Partial Dentures versus Metal Cobalt-Chromium. RESEARCH JOURNAL OF PHARMACEUTICAL BIOLOGICAL AND CHEMICAL SCIENCES. 2016 Jul 1;7(4):464-70.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03777345
Lead sponsor
Cairo University
Responsible party
Ahmed Hefny Zidan (principle investigator, Cairo University) — Principal investigator
First posted
Dec 17, 2018
Start date
Jan 1, 2019 (estimated)
Primary completion
Apr 1, 2019 (estimated)
Completion
Jul 1, 2019 (estimated)
Last update
Dec 17, 2018

Study contacts

Ahmed He Zidan, master
Contact
ahmedhefnyf@gmail.com
+201126534668
Amr Ha Mohammed, master
Contact
amr_hatim@yahoo.com
+201001600625

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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