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

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ClinicalTrials.gov Identifier: NCT04686370
Recruitment Status : Enrolling by invitation
First Posted : December 28, 2020
Last Update Posted : December 28, 2020
Sponsor:
Information provided by (Responsible Party):
Marwan Mohamed Abdelsalam, Cairo University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Complete Edentulism Other: laser treated implant surface Not Applicable

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)

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: one single group will receive both types of dental implants (Split-mouth)
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Different Implant Surface Treatments on Bony Changes Around Mandibular Implants for Completely Edentulous Patients (A Split-mouth Comparative Study)
Actual Study Start Date : October 6, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: sandblasted acid-etched implants
implant will be installed intraforaminal
 Other: laser treated implant surface
Better marginal bone stability is expected for this type
Experimental: laser treated implants
implant will be installed intraforaminal
 Other: laser treated implant surface
Better marginal bone stability is expected for this type


Outcome Measures
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Primary Outcome Measures :
  1. Marginal bone stability around dental implants [ Time Frame: 1 year ]
    Measuring amount of marginal bone loss by radiographic assessment using long paralleling technique periapical digital x-ray(SOREDEX™ DIGORA™ Optime)


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04686370


Locations
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Egypt
Faculty of dentistry,cairo university
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Marwan Mohamed, Investigator Cairo University
More Information
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Responsible Party: Marwan Mohamed Abdelsalam, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT04686370    
Other Study ID Numbers: 20-2-34
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marwan Mohamed Abdelsalam, Cairo University:
Dental implant
Surface treatment
Laser
Sandblasted Acid-etched implants
 Delayed-loading
Bony changes
Marginal bone loss