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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 13, 2019
First Posted Date  ICMJE September 17, 2019
Last Update Posted Date September 24, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
implant stability [ Time Frame: 3 months ]
measuring implant stability using Resonance Frequency Analysis device to measure Implant stability quotient (ISQ) units
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implant Stability of Laser vs SLA Surface Treated Implants Placed in Fresh Extraction Sockets
Official Title  ICMJE Primary Implant Stability of Laser Surface Treated Versus Sand Blasted/Acid Etched Surface Treated Implants in Fresh Extraction Sockets: A Randomized Clinical Trial
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 .

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Implant Site Reaction
Intervention  ICMJE 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.

Study Arms  ICMJE 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
Intervention: Device: laser and SLA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 13, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04092920
Other Study ID Numbers  ICMJE PRO 6-3-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ahmed mohamed mohamed abd el maksoud, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP