NCT07262307

Brief Summary

Evaluation of PEEK versus Titanium Bar Attachments with Implant Assisted Mandibular Complete Overdenture fabricated by CAD/CAM Technology measuring retention of the overdenture and implant evaluation for 6 months and one year

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
May 2024Sep 2026

Study Start

First participant enrolled

May 30, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

December 3, 2025

Status Verified

February 1, 2025

Enrollment Period

2.3 years

First QC Date

September 7, 2025

Last Update Submit

November 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • retention of mandibular overdenture

    Retention of the mandibular implant-assisted complete overdenture will be measured using a digital force meter. Measurements will be taken at 6 months and 12 months after denture insertion.

    6 months and 12 months post-insertion

Study Arms (4)

Evaluation of PEEK material

EXPERIMENTAL

digital fabrications techniques

Device: implant overdenture

Group Ӏ (control group): Six patients will receive digital mandibular implant overdenture assisted b

ACTIVE COMPARATOR

• Clinical evaluation

Device: implant overdenture

PEEK group new material

EXPERIMENTAL
Device: implant overdenture

PEEK material study group

EXPERIMENTAL
Device: implant overdenture

Interventions

using of CAD/CAM with new material and digital fabrication techniques

Evaluation of PEEK materialGroup Ӏ (control group): Six patients will receive digital mandibular implant overdenture assisted bPEEK group new materialPEEK material study group

Eligibility Criteria

Age45 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Completely edentulous patients free from systemic diseases that may affect soft or hard tissue healing.
  • Patient's age ranges from 40 to 60 years old.
  • The bone quality and quantity of the mandibular alveolar ridge must fulfill the criteria for implant placement.
  • They have normal class Ӏ maxilla-mandibular relationship and sufficient inter-arch space with at least 25mm for bar attachment.
  • They have good oral hygiene.

You may not qualify if:

  • Systemic disorders that may influence soft or hard tissue healing as oral diseases.
  • Patients with history of radiation therapy in the head and neck region.
  • Patients with neurological or psychological problems that may impair good oral hygiene.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Tanta, Elgharbiy, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 7, 2025

First Posted

December 3, 2025

Study Start

May 30, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

December 3, 2025

Record last verified: 2025-02

Locations