Skip to main content
OpenTrials
Completed

NCT Number: NCT03003624

Comparing the Outcomes of Incisions Made by Colorado® Microdissection Needle

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

SVS Institute of Dental Sciences, Mahabubnagar

Hyderabad, Andhra Pradesh, 509002, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colorado® microdissection needle

Device

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.

Cautery tip

Device

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.

BP blade

Device

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 outcomes

  1. Quantity of blood loss in ml

    Time frame: Immediate postoperative volume

    Quantity of blood loss by swab weighing method.

  2. PPD in mm

    Time frame: 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.

  3. Changes in dimensions of interdental papilla in mm

    Time frame: Baseline to 180 days

    Changes in dimensions of interdental papilla using a periodontal probe.

Secondary outcomes

  1. Assessment of postoperative pain:

    Time frame: 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.

  2. Assessment of wound healing:

    Time frame: 1 day, 7 & 15 days

    Wound healing was recorded using Early wound healing index (EHI).

Sponsors and collaborators

Lead sponsor

SVS Institute of Dental Sciences

Other

Registry information

Official study title

Comparing the Outcomes Of Incisions Made By Colorado® Microdissection Needle, Electrosurgery Tip And Surgical Blade During Periodontal Surgery

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 28, 2016
Registry last updated
Dec 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.