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NCT04686370 Clinical Trial

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

Complete Edentulism Clinical Trial

Official title:
Effect of Different Implant Surface Treatments on Bony Changes Around Mandibular Implants for Completely Edentulous Patients (A Split-mouth Comparative Study)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04686370
Other study ID # 20-2-34
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 6, 2020
Est. completion date October 2021

Study information
Verified date December 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 13
Est. completion date October 2021
Est. primary completion date October 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• laser treated implant surface
Better marginal bone stability is expected for this type

Locations
Country Name City State
Egypt Faculty of dentistry,cairo university Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) 1 year
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