Comparing the Outcomes of Incisions Made by Colorado® Microdissection Needle
Primary Purpose
Periodontitis
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Colorado® microdissection needle
Cautery tip
BP blade
Sponsored by

About this trial
This is an interventional treatment trial for Periodontitis focused on measuring Incisions, microdissection needle
Eligibility Criteria
Inclusion Criteria:
- Systemically healthy individuals within the age group of 25-45 years having at least 20 teeth remaining in the mouth of which at least 4 teeth in each quadrant requiring periodontal surgery, patients with periodontal pockets with ≥5 mm in depth suitable for modified Widman flap were included in the study.
Exclusion Criteria:
- Patients who underwent periodontal therapy in the past 6 months, medically compromised patients, patients with poorly shielded cardiac pacemakers were excluded from the study.
Sites / Locations
- SVS Institute of Dental Sciences, Mahabubnagar
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Colorado microdissection needle group
Cautery group
BP Blade group
Arm Description
In patients selected for Colorado® needle group incision was given with Colorado® needle tip ( N103 A which is 3 cm length straight, 3/32 in sleeve diameter),
Electrosurgery tip was used to give incisions.
No.15 surgical blade was used to give incisions.
Outcomes
Primary Outcome Measures
Quantity of blood loss in ml
Quantity of blood loss by swab weighing method.
PPD in mm
Probing pocket depths (PPD) were recorded using a University of North Carolina no. 15 (UNC -15) color-coded periodontal probe at baseline, 120 and 180 days after surgery.
Changes in dimensions of interdental papilla in mm
Changes in dimensions of interdental papilla using a periodontal probe.
Secondary Outcome Measures
Assessment of postoperative pain:
Postoperative pain was assessed by using visual analogue scale (VAS) which was recorded 1 day, 7 & 15 days after surgery. The visual analogue scale (VAS) consists of a line, usually 10 cm long, whose ends are labelled as the extremes ('no pain' and 'severe pain'). The patients were asked to mark on the line which indicated their pain intensity.
Assessment of wound healing:
Wound healing was recorded using Early wound healing index (EHI).
Full Information
NCT ID
NCT03003624
First Posted
December 20, 2016
Last Updated
December 21, 2016
Sponsor
SVS Institute of Dental Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03003624
Brief Title
Comparing the Outcomes of Incisions Made by Colorado® Microdissection Needle
Official Title
Comparing the Outcomes Of Incisions Made By Colorado® Microdissection Needle, Electrosurgery Tip And Surgical Blade During Periodontal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SVS Institute of Dental Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the present study was to compare the outcomes of incisions made by Colorado® microdissection needle, electrosurgery tip and surgical blade during periodontal surgery.
Detailed Description
Commercially, many microdissection needle systems are available, such as Stryker Colorado® microdissection needle (CMN) (Stryker-Leibinger, Freiburg, Germany) and optimicro™ microdissection needles. Colorado® microdissection needle (CMN) combine the advantages of scalpel and electrosurgery. CMN® was introduced into clinical practice in 1997, with a wide array of applications in the field of Ophthalmology, Neurosurgery, and others.
The primary feature of the Colorado® microdissection needle is the ultra-sharp tungsten tip that delivers the wave-form from the electrosurgery generator to a very small spot. This allows the use of extremely low wattages, resulting in less tissue necrosis, precision cutting and cautery, and less post-operative pain. The instrument tip is a delicately machined, insulated tungsten diathermy needle that is compatible with any standard cautery hand piece. Tungsten, with its extremely high melting point (>3400°C) provides a heat resistant tip that maintains sharpness compared to stainless steel tips that dull rapidly.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Incisions, microdissection needle
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Colorado microdissection needle group
Arm Type
Experimental
Arm Description
In patients selected for Colorado® needle group incision was given with Colorado® needle tip ( N103 A which is 3 cm length straight, 3/32 in sleeve diameter),
Arm Title
Cautery group
Arm Type
Experimental
Arm Description
Electrosurgery tip was used to give incisions.
Arm Title
BP Blade group
Arm Type
Active Comparator
Arm Description
No.15 surgical blade was used to give incisions.
Intervention Type
Device
Intervention Name(s)
Colorado® microdissection needle
Intervention Description
The primary feature of the Colorado® microdissection needle is the ultra-sharp tungsten tip that delivers the wave-form from the electrosurgery generator to a very small spot. This allows the use of extremely low wattages, resulting in less tissue necrosis, precision cutting and cautery, and less post-operative pain.
Intervention Type
Device
Intervention Name(s)
Cautery tip
Intervention Description
Studies have shown that, heat generated by electrosurgical devices are influenced by factors like duration of contact between tissue and electrode tip, current intensity, electro section waveform and the electrode tip size. A larger tip causes more tissue damage, increased operating power and more amount of lateral heat production. This led to the development of microdissection needle with fine electrode tip and efficient power usage. The use of microdissection needles does not have any significant difference in wound healing or pain when compared with scalpel.
Intervention Type
Device
Intervention Name(s)
BP blade
Intervention Description
Studies have shown that, heat generated by electrosurgical devices are influenced by factors like duration of contact between tissue and electrode tip, current intensity, electro section waveform and the electrode tip size. A larger tip causes more tissue damage, increased operating power and more amount of lateral heat production. This led to the development of microdissection needle with fine electrode tip and efficient power usage. The use of microdissection needles does not have any significant difference in wound healing or pain when compared with scalpel.
Primary Outcome Measure Information:
Title
Quantity of blood loss in ml
Description
Quantity of blood loss by swab weighing method.
Time Frame
Immediate postoperative volume
Title
PPD in mm
Description
Probing pocket depths (PPD) were recorded using a University of North Carolina no. 15 (UNC -15) color-coded periodontal probe at baseline, 120 and 180 days after surgery.
Time Frame
Baseline to 180 days
Title
Changes in dimensions of interdental papilla in mm
Description
Changes in dimensions of interdental papilla using a periodontal probe.
Time Frame
Baseline to 180 days
Secondary Outcome Measure Information:
Title
Assessment of postoperative pain:
Description
Postoperative pain was assessed by using visual analogue scale (VAS) which was recorded 1 day, 7 & 15 days after surgery. The visual analogue scale (VAS) consists of a line, usually 10 cm long, whose ends are labelled as the extremes ('no pain' and 'severe pain'). The patients were asked to mark on the line which indicated their pain intensity.
Time Frame
1 day, 7 & 15 days
Title
Assessment of wound healing:
Description
Wound healing was recorded using Early wound healing index (EHI).
Time Frame
1 day, 7 & 15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Systemically healthy individuals within the age group of 25-45 years having at least 20 teeth remaining in the mouth of which at least 4 teeth in each quadrant requiring periodontal surgery, patients with periodontal pockets with ≥5 mm in depth suitable for modified Widman flap were included in the study.
Exclusion Criteria:
Patients who underwent periodontal therapy in the past 6 months, medically compromised patients, patients with poorly shielded cardiac pacemakers were excluded from the study.
Facility Information:
Facility Name
SVS Institute of Dental Sciences, Mahabubnagar
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
509002
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Publication data will be shared
Learn more about this trial
Comparing the Outcomes of Incisions Made by Colorado® Microdissection Needle
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