- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04998292
Piezo-surgical Implant With Laser
August 3, 2021 updated by: Mahmoud Sedky, Cairo University
Piezo-surgical Implant Placement With Laser
Evaluation of the effect of laser with piezo-surgical device in dental implants
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Mahmoud
-
Contact:
- Mahmoud Sedky
- Phone Number: 01091783307
- Email: dr.mahmoud.sedky@gmail.com
-
-
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
18 years to 49 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subjects having good oral hygiene
- History of bilateral extractions in the lower molar area not less than 6 months ago.
Exclusion Criteria:
- Patients with debilitating diseases or bad oral hygiene,
- Patients with parafunctional habits and patients who are taking analgesics or with alcohol abuse.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
|
Piezo-surgery only
|
Experimental: Low level laser therapy
|
Low level laser therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of pain
Time Frame: 2 hours after surgery
|
2 hours after surgery
|
Assessment of pain using visual analog scale
Time Frame: 6 hours after surgery
|
6 hours after surgery
|
Assessment of pain using visual analog scale
Time Frame: 24 hours after surgery
|
24 hours after surgery
|
Assessment of pain using visual analog scale
Time Frame: 2 days after surgery
|
2 days after surgery
|
Assessment of pain using visual analog scale
Time Frame: 3 days after surgery
|
3 days after surgery
|
Assessment of pain using visual analog scale
Time Frame: 4 days after surgery
|
4 days after surgery
|
Assessment of pain using visual analog scale
Time Frame: 7 days after surgery
|
7 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Swelling using swelling score system
Time Frame: 2 hours after surgery
|
2 hours after surgery
|
Swelling using swelling score system
Time Frame: 6 hours after surgery
|
6 hours after surgery
|
Swelling using swelling score system
Time Frame: 24 hours after surgery
|
24 hours after surgery
|
Swelling using swelling score system
Time Frame: 2 days after surgery
|
2 days after surgery
|
Swelling
Time Frame: 3 days after surgery
|
3 days after surgery
|
Swelling using swelling score system
Time Frame: 4 days after surgery
|
4 days after surgery
|
Swelling using swelling score system
Time Frame: 7 days after surgery
|
7 days after surgery
|
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 (Actual)
July 21, 2021
Primary Completion (Anticipated)
August 15, 2021
Study Completion (Anticipated)
August 17, 2021
Study Registration Dates
First Submitted
July 19, 2021
First Submitted That Met QC Criteria
August 3, 2021
First Posted (Actual)
August 10, 2021
Study Record Updates
Last Update Posted (Actual)
August 10, 2021
Last Update Submitted That Met QC Criteria
August 3, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/82-2021
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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