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

NCT ID: NCT04686370

Last Updated: 2020-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-06

Study Completion Date

2021-10-31

Brief Summary

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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.

Detailed Description

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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)

Conditions

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Complete Edentulism

Keywords

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Dental implant Surface treatment Laser Sandblasted Acid-etched implants Delayed-loading Bony changes Marginal bone loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

one single group will receive both types of dental implants (Split-mouth)
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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sandblasted acid-etched implants

implant will be installed intraforaminal

Group Type ACTIVE_COMPARATOR

laser treated implant surface

Intervention Type OTHER

Better marginal bone stability is expected for this type

laser treated implants

implant will be installed intraforaminal

Group Type EXPERIMENTAL

laser treated implant surface

Intervention Type OTHER

Better marginal bone stability is expected for this type

Interventions

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laser treated implant surface

Better marginal bone stability is expected for this type

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Marwan Mohamed Abdelsalam

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marwan Mohamed, Investigator

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Faculty of dentistry,cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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20-2-34

Identifier Type: -

Identifier Source: org_study_id