Comparison of Post-operative Complications of Bone Augmentation at Anterior of Maxilla After Periosteal Releasing Incision With Two Techniques Diode Laser and Scalpel
Primary Purpose
Post-operative Pain
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Laser-assisted surgery.
conventional surgery by blade
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Pain focused on measuring post-operative pain, diode laser
Eligibility Criteria
Inclusion Criteria:
- patients with the need for a single-tooth replacement in the maxilla by implant and simultaneous GBR
Exclusion Criteria:
- general contraindication for bone augmentation or implant surgeries,
- existence of swelling or pain at the time of surgery,
- smoking habits, pregnancy, and lactation.
Sites / Locations
- Tehran University of Medical Sciences
- Neda Moslemi
- Tehran University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Laser irradiation
blade
Arm Description
laser-assisted surgery with the following parameters: Wavelength:810 nanometer, power: 3 W, pulse mode,pulse length 100 µs, pulse interval 200 µs
conventional surgery by blade
Outcomes
Primary Outcome Measures
post-operative swelling intensity
Swelling on the operated side was evaluated as follows: 0 (none: no inflammation), 1 (mild: intraoral swelling confined to the surgical field), 2 (moderate: extra oral swelling in the surgical zone), or 3 (intense: extra oral swelling spreading beyond the surgical zone).
Secondary Outcome Measures
post-operative pain intensity
Postoperative pain was measured using a visual analog scale (VAS) ranging from zero for "no pain" to 100 for "the worst possible pain".(questionnaire)
implant success
based on Albrektsson success criteria.
Full Information
NCT ID
NCT02711501
First Posted
February 4, 2016
Last Updated
September 10, 2016
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02711501
Brief Title
Comparison of Post-operative Complications of Bone Augmentation at Anterior of Maxilla After Periosteal Releasing Incision With Two Techniques Diode Laser and Scalpel
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study was to investigate if using lasers instead of scalpel for flap advancement in bone augmentation procedures would reduce post-operative swelling and pain.
Detailed Description
Guided bone regeneration (GBR) is a well established method to augment excessive alveolar bone loss before and at the time of implant placement. Primary closure of soft tissue is a prerequisite for successful bone augmentation procedures. Adequate flap advancement is a key factor for tension free primary wound closure. The tension free flap is usually attained by incising the buccal flap using scalpels. However, this procedure, especially in cases with major flap advancement, results in increased patient morbidity after surgery. Swelling and hemorrhage during the first week after surgery have a negative effect on patient's quality of life.
Currently, lasers are widely used as a tool for soft tissue management and diode laser appears to be an effective tool for incision and excision of the soft tissue. The major advantageous property of lasers is ablation of tissue together with effective hemostasis, minimal swelling and virtually no pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
Keywords
post-operative pain, diode laser
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser irradiation
Arm Type
Experimental
Arm Description
laser-assisted surgery with the following parameters: Wavelength:810 nanometer, power: 3 W, pulse mode,pulse length 100 µs, pulse interval 200 µs
Arm Title
blade
Arm Type
Experimental
Arm Description
conventional surgery by blade
Intervention Type
Procedure
Intervention Name(s)
Laser-assisted surgery.
Intervention Description
laser-assisted surgery
Intervention Type
Procedure
Intervention Name(s)
conventional surgery by blade
Intervention Description
conventional surgery
Primary Outcome Measure Information:
Title
post-operative swelling intensity
Description
Swelling on the operated side was evaluated as follows: 0 (none: no inflammation), 1 (mild: intraoral swelling confined to the surgical field), 2 (moderate: extra oral swelling in the surgical zone), or 3 (intense: extra oral swelling spreading beyond the surgical zone).
Time Frame
Within the first 6 days after surgery
Secondary Outcome Measure Information:
Title
post-operative pain intensity
Description
Postoperative pain was measured using a visual analog scale (VAS) ranging from zero for "no pain" to 100 for "the worst possible pain".(questionnaire)
Time Frame
Within the first 6 days after surgery
Title
implant success
Description
based on Albrektsson success criteria.
Time Frame
3 months later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with the need for a single-tooth replacement in the maxilla by implant and simultaneous GBR
Exclusion Criteria:
general contraindication for bone augmentation or implant surgeries,
existence of swelling or pain at the time of surgery,
smoking habits, pregnancy, and lactation.
Facility Information:
Facility Name
Tehran University of Medical Sciences
City
Tehran
ZIP/Postal Code
141555583
Country
Iran, Islamic Republic of
Facility Name
Neda Moslemi
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
Tehran University of Medical Sciences
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Comparison of Post-operative Complications of Bone Augmentation at Anterior of Maxilla After Periosteal Releasing Incision With Two Techniques Diode Laser and Scalpel
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