CClinicalTrials.gg
Status unknownNCT04686370Updated Dec 28, 2020

Effect of Different Implant Surface Treatments on Bony Changes Around Mandibular Implants

An interventional study of laser treated implant surface in Complete Edentulism, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-28.

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

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
35 Years to 60 Years
Sex
All
01

Study summary

The research will be conducted to report which type of surface treatment of dental implants that can be successful and aids in increasing bone to implant contact and how it affects the bony changes around the implants installed in mandibular arches for completely edentulous patients or whether there are specific precautions to be taken into consideration during implant planning concerned with the type of surface microstructure treatment and recommendations needed.

Read the detailed description

Primary objective:

PICO P: Completely edentulous patients I: Laser surface treatment of implants C: Sandblasted Acid etched surface treatment O: Bony changes

Each Participants will have 2 implants;one laser surface treated implants and another sandblasted acid-etched implant (split-mouth) installed in the intra-foraminal area of mandibular arch prosthetically driven by the prepared conventional denture. MS and AF are responsible for delayed-loading of the denture and will measure bony changes around laser treated surface implants using radiographic assessment using long paralleling technique periapical digital x-ray(SOREDEX™ DIGORA™ Optime)

02

Conditions studied

  • Complete Edentulism

Keywords

  • Dental implant
  • Surface treatment
  • Laser
  • Sandblasted Acid-etched implants
  • Delayed-loading
  • Bony changes
  • Marginal bone loss
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
35 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Completely edentulous patients
  • Angle's class 1 skeletal relationship
  • Normal facial asymmetry
  • Cooperative patients
  • Adequate inter-arch spcae not less than 12mm

Exclusion criteria

Exclusion Criteria:

  • Tempromandibular joint disorder
  • Uncontrolled diabetes
  • Bleeding disorders or anticoagulant therapy
  • Flabby tissues or sharp mandibular residual ridge
  • Heavy smoker
  • Patient's with neuromuscular disorders
  • Patients on chemotherapy or radiotherapy
  • Severe psychiatric disorders
05

Study design

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

Study arms

  • Active comparator
    sandblasted acid-etched implants

    implant will be installed intraforaminal

    Other: laser treated implant surface

  • Experimental
    laser treated implants

    implant will be installed intraforaminal

    Other: laser treated implant surface

Interventions

  • Otherlaser treated implant surface

    Better marginal bone stability is expected for this type

06

What researchers measure

Primary outcomes

  1. Marginal bone stability around dental implants

    Measuring amount of marginal bone loss by radiographic assessment using long paralleling technique periapical digital x-ray(SOREDEX™ DIGORA™ Optime)

    Time frame: 1 year

07

Study locations

1 site
  • Faculty of dentistry,cairo university
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No

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 Dec 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04686370
Lead sponsor
Cairo University
Responsible party
Marwan Mohamed Abdelsalam (principal investigator, Cairo University) — Principal investigator
First posted
Dec 28, 2020
Start date
Oct 6, 2020
Primary completion
Oct 2021 (estimated)
Completion
Oct 2021 (estimated)
Last update
Dec 28, 2020

Study contacts

Marwan Mohamed, Investigator
principal investigator · Cairo University

Oversight

Data monitoring committee
No
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 2020. You cannot join it, but the record below documents what was studied.

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