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Piezo-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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
July 19, 2021
Last Updated
August 3, 2021
Sponsor
Cairo University
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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

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Piezo-surgical Implant With Laser

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