Back to resultsPiezo-surgical Implant With Laser
Primary Purpose
Effect of Piezo-surgical Implant With Laser on Pain and Swelling in Patients With Missing Teeth
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Piezo-surgery with low level laser therapy
Piezo-surgery only
Sponsored by
About this trial
This is an interventional treatment trial for Effect of Piezo-surgical Implant With Laser on Pain and Swelling in Patients With Missing Teeth
Eligibility Criteria
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.
Sites / Locations
- MahmoudRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low level laser therapy
Control
Arm Description
Outcomes
Primary Outcome Measures
Assessment of pain
Assessment of pain using visual analog scale
Assessment of pain using visual analog scale
Assessment of pain using visual analog scale
Assessment of pain using visual analog scale
Assessment of pain using visual analog scale
Assessment of pain using visual analog scale
Secondary Outcome Measures
Swelling using swelling score system
Swelling using swelling score system
Swelling using swelling score system
Swelling using swelling score system
Swelling
Swelling using swelling score system
Swelling using swelling score system
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04998292
Brief Title
Piezo-surgical Implant With Laser
Official Title
Piezo-surgical Implant Placement With Laser
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
August 15, 2021 (Anticipated)
Study Completion Date
August 17, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Evaluation of the effect of laser with piezo-surgical device in dental implants
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Piezo-surgical Implant With Laser on Pain and Swelling in Patients With Missing Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
split mouth study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low level laser therapy
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Piezo-surgery with low level laser therapy
Intervention Description
Low level laser therapy
Intervention Type
Device
Intervention Name(s)
Piezo-surgery only
Intervention Description
Piezo-surgery only
Primary Outcome Measure Information:
Title
Assessment of pain
Time Frame
2 hours after surgery
Title
Assessment of pain using visual analog scale
Time Frame
6 hours after surgery
Title
Assessment of pain using visual analog scale
Time Frame
24 hours after surgery
Title
Assessment of pain using visual analog scale
Time Frame
2 days after surgery
Title
Assessment of pain using visual analog scale
Time Frame
3 days after surgery
Title
Assessment of pain using visual analog scale
Time Frame
4 days after surgery
Title
Assessment of pain using visual analog scale
Time Frame
7 days after surgery
Secondary Outcome Measure Information:
Title
Swelling using swelling score system
Time Frame
2 hours after surgery
Title
Swelling using swelling score system
Time Frame
6 hours after surgery
Title
Swelling using swelling score system
Time Frame
24 hours after surgery
Title
Swelling using swelling score system
Time Frame
2 days after surgery
Title
Swelling
Time Frame
3 days after surgery
Title
Swelling using swelling score system
Time Frame
4 days after surgery
Title
Swelling using swelling score system
Time Frame
7 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Mahmoud
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Sedky
Phone
01091783307
Email
dr.mahmoud.sedky@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Piezo-surgical Implant With Laser
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