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CompletedNCT06639893Updated Oct 15, 2024

Crestal Bone Loss in Mandibular Telescopic Overdentures. Overdenture with Milled Titanium, Milled Poly-ether Ketone Ketones and 3D Printed Chrome Cobalt Secondary Copings.

An Early Phase 1 interventional study of Telescopic overdenture in Telescopic Overdentures, Dental Implants and Customized Abutments, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 55 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Cairo University · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Aug 2023, registered Oct 2024).
Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
55 Years to 75 Years
Sex
All
01

Study summary

The objective of this clinical trial is to evaluate crestal bone loss every three months at time of overdenture insertion, 3, 6, 9, 12 months from overdenture use. Also, to evaluate prosthesis satisfaction.

All participants will receive conventional complete dentures, followed by two intraforaminal implants. After healing time, fabrication of secondary copings in all cases according to randomized groups for final overdenture insertion.

02

Conditions studied

  • Telescopic Overdentures
  • Dental Implants
  • Customized Abutments
03

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.

04

Who can participate

Ages eligible
55 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Sufficient remaining bone in height, width and thickness in the interforaminal area to allow installation of at least 3.3 mm diameter and 8 mm length implants.
  2. Adequate amount of interarch space of at least 12mm.
  3. Age range from 55 to 75 years old age.

Exclusion criteria

Exclusion Criteria:

  1. Systemic and metabolic diseases that may affect osseointegration.
  2. Patients receiving bisphosphonates therapy.
  3. Patients under radiotherapy or chemotherapy.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Milled Titanium secondary copings

    Procedure: Telescopic overdenture

  • Experimental
    3D printed chrom cobalt copings.

    Procedure: Telescopic overdenture

  • Experimental
    Milled Poly-ether Ketone Ketones copings.

    Procedure: Telescopic overdenture

Interventions

  • ProcedureTelescopic overdenture

    Telescopic overdenture with two dental implants in intraforaminal area for mandible.

06

What researchers measure

Primary outcomes

  1. Crestal bone loss.

    The aim of this study was to evaluate crestal peri implant bone loss in mandibular telescopic implant retained overdenture with milled titanium, milled poly-ether ketone ketones and 3D printed chrome cobalt secondary copings. Crestal bone loss evaluated every three months using standardized digital periapical radiograph at time of overdenture insertion, 3, 6, 9, and after 12 months from overdenture use.

    Time frame: one year

07

Study locations

1 site
  • EL Minia University
    El minia, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06639893
Lead sponsor
Cairo University
Collaborators
Minia University
Responsible party
Moustafa mohamed el maghraby (Assistant lecturer of prosthodontics, Minia University) — Principal investigator
First posted
Oct 15, 2024
Start date
Aug 1, 2023
Primary completion
Aug 1, 2024
Completion
Oct 1, 2024
Last update
Oct 15, 2024

Oversight

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

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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