- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04100382
Laser Treated vs SLA Treated Short Implants in Terms of Stability.
September 20, 2019 updated by: Hassan Alaa Diab, Cairo University
Implant Stability in Laser Treated Surface vs SLA Treated Short Implants (Randomized Clinical Trial)
Laser treated short dental implants will be placed in a posterior atrophic ridge with only 8-10 mm available bone height.
Their stability will be measured through a period of 12 weeks.
They will be compared to the stability of SLA treated Short dental implants placed in the same situations.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Laser treated short dental implants will be placed in a posterior atrophic ridge with only 8-10 mm available bone height.
Their stability will be measured through a period of 12 weeks.
They will be compared to the stability of SLA treated Short dental implants placed in the same situations.
Study Type
Interventional
Enrollment (Anticipated)
8
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Adult patients with Edentulous posterior maxillae with insufficient ridge for placement of standard length dental implant, but allowing placement of short 8mm dental implant.
- Males and females.
Exclusion Criteria:
• 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, or bone augmentation to implant site
- Patients suffering from immunodeficiency, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
- Intraoral soft and hard tissue pathology.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Laser and SLA implants
Surgical placement of short implants in maxillary posterior teeth with Laser surface treated and SLA surface treated dental implants
|
Patients will be randomized into two groups, control group for SLA implants, and study group will receive the Laser treated implants.
Implants will be placed classically in the posterior maxillary region and their stability will be measured by ISQ device at the placement.
Measurements will be taken again at 2, 4, 6, 8 , 10 and 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of change in implant stability at base line, 2,4,8, 12 weeks
Time Frame: 3 months
|
measuring implant stability with resonance frequency analysis device using implant stability quotation (ISQ) that measures the stiffness and deflection of implant bone complex.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 15, 2019
Primary Completion (Anticipated)
September 15, 2020
Study Completion (Anticipated)
September 15, 2020
Study Registration Dates
First Submitted
September 13, 2019
First Submitted That Met QC Criteria
September 20, 2019
First Posted (Actual)
September 24, 2019
Study Record Updates
Last Update Posted (Actual)
September 24, 2019
Last Update Submitted That Met QC Criteria
September 20, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 1719
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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