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Implant Stability of Laser vs SLA Surface Treated Implants Placed in Fresh Extraction Sockets

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ClinicalTrials.gov Identifier: NCT04092920
Recruitment Status : Unknown
Verified September 2019 by ahmed mohamed mohamed abd el maksoud, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
ahmed mohamed mohamed abd el maksoud, Cairo University

Study Description
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Brief Summary:

Commercially available implant surfaces are moderately roughened surfaces and they are obtained by acid-etching following alumina or titanium oxide grit-blasting.

Although the micro-rough implants can be successful in compromised clinical scenarios, the bioinert nature of titanium surfaces cannot stimulate a more rapid bone regeneration and mechanical fixation of dental implants.

Laser surface treatment is used to produce an implant surface modification on the nano-scale with controlled and reproducible patterns in addition to exhibiting a sterilizing effect and achieving efficient oxidation .


Condition or disease Intervention/treatment Phase
Implant Site Reaction Device: laser and SLA Not Applicable

Detailed Description:

For dental implant to be successful, a direct contact between the bone tissue and the surface of the implant should be developed & this physiological phenomenon is known by the term of osseointegration.

Initially, it was supposed that to achieve osseointegration, implants had to be submerged under the mucosa & left without any loading for a period of 3-4 months in mandible and 6-8 months in maxilla.

Recently immediate implant placement at the time of extraction has become a viable treatment alternative, this approach provides the advantages of decreasing the patient's discomfort, the treatment's duration and costs.

Aiming to reduce healing process to limit such changes in the soft & hard tissues and reducing treatment time, several alterations in both surgical and restorative procedures has been introduced. From an implant design perspective, two approaches including the fields of biomaterials and/or biomechanics have been most utilized; implant body design which aim to increase the primary stability and surface modifications to allow faster osseointegration process.

Rough implant surface is modified by different techniques. Among these different techniques, interest in of using laser to achieve roughened surfaces.

Commercially available implant surfaces are moderately roughened surfaces and they are obtained by acid-etching following alumina or titanium oxide grit-blasting.

Although the micro-rough implants can be successful in compromised clinical scenarios, the bioinert nature of titanium surfaces cannot stimulate a more rapid bone regeneration and mechanical fixation of dental implants.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Primary Implant Stability of Laser Surface Treated Versus Sand Blasted/Acid Etched Surface Treated Implants in Fresh Extraction Sockets: A Randomized Clinical Trial
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: laser and SLA implants
extraction of badly broken maxillary and mandibular teeth with immediate implant placement using laser surface treated and SLA surface treated dental implants
 Device: laser and SLA

ligible patients will be randomized to 2 groups control group will receive SLA surface treated implant to replace badly broken tooth immediately after extraction and a study group will receive laser surface treated implant to replace badly broken tooth immediately after extraction.

atraumatic extraction will be performed and socket will be examined for presence of bone dehesince or fenestration if no, implant will be placed immediately and a implant primary stability will be measured using an ISQ unit and recorded as base Line reading .

gingival former will be attached to the implant and removed at 2 ,4,8,12 week intervals to record ISQ readings.


Outcome Measures
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Primary Outcome Measures :
  1. rate of change in implant stability at baseline,2,4,8,12 weeks [ Time Frame: 3 months ]
    measuring implant stability with Resonance Frequency Analysis device using Implant stability quotient (ISQ) units that measure the stiffness and deflection of the implant-bone complex.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with badly broken teeth indicated for extraction. • Presence of adequate bone beyond the root apex to guarantee implant primary stability & implant placement within the alveoli confines.

Exclusion Criteria:

  • • Presence of acute infections in the implant site.

    • Presence of fenestrations or dehiscence of the residual bony walls after extraction.
    • Heavy smokers more than 20 cigarettes per day.
    • Patients with systemic disease that may affect normal healing.
    • Psychiatric problems.
    • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia.
    • Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
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): NCT04092920


Contacts
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Contact: ahmed mohamed mohamed abd el maksoud, bds 01061597677 drabdelmaksoud33@gmail.com
Contact: amr hosny el khadem, associate professor 01001162401 amr.elkhadem@dentistry.cu.edu.eg

Locations
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Egypt
Cairo University
Cairo, Egypt
Contact: amr hosny el khadem, associate professor    01001162401    amr.elkhadem@dentistry.cu.edu.eg   
Contact: magdy zarea    0201144252034    magdyzarea@yahoo.com   
Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: ahmed mohamed mohamed abd el maksoud, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT04092920    
Other Study ID Numbers: PRO 6-3-1
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No