Comparing the Outcomes of Incisions Made by Colorado® Microdissection Needle
- Conditions
- Periodontitis
- Interventions
- Device: BP bladeDevice: Colorado® microdissection needleDevice: Cautery tip
- Registration Number
- NCT03003624
- Lead Sponsor
- SVS Institute of Dental Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- Patients who underwent periodontal therapy in the past 6 months, medically compromised patients, patients with poorly shielded cardiac pacemakers were excluded from the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BP Blade group BP blade No.15 surgical blade was used to give incisions. Colorado microdissection needle group Colorado® microdissection needle 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), Cautery group Cautery tip Electrosurgery tip was used to give incisions.
- Primary Outcome Measures
Name Time Method Quantity of blood loss in ml Immediate postoperative volume Quantity of blood loss by swab weighing method.
PPD in mm Baseline to 180 days 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 Baseline to 180 days Changes in dimensions of interdental papilla using a periodontal probe.
- Secondary Outcome Measures
Name Time Method Assessment of postoperative pain: 1 day, 7 & 15 days 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: 1 day, 7 & 15 days Wound healing was recorded using Early wound healing index (EHI).
Trial Locations
- Locations (1)
SVS Institute of Dental Sciences, Mahabubnagar
🇮🇳Hyderabad, Andhra Pradesh, India