Comparing the Outcomes of Incisions Made by Colorado® Microdissection Needle

NCT03003624 | Completed Phase 3 DMC

• 1 other identifier: SVSIEC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

Incisions; microdissection needle

Outcome Measures

Primary Outcomes (3)

• Quantity of blood loss in ml

  Quantity of blood loss by swab weighing method.

  Immediate postoperative volume

• 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.

  Baseline to 180 days

• Changes in dimensions of interdental papilla in mm

  Changes in dimensions of interdental papilla using a periodontal probe.

  Baseline to 180 days

Secondary Outcomes (2)

• Assessment of postoperative pain:

  1 day, 7 & 15 days

• Assessment of wound healing:

  1 day, 7 & 15 days

Study Arms (3)

Colorado microdissection needle group

EXPERIMENTAL

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),

Device: Colorado® microdissection needle

Cautery group

EXPERIMENTAL

Electrosurgery tip was used to give incisions.

Device: Cautery tip

BP Blade group

ACTIVE COMPARATOR

No.15 surgical blade was used to give incisions.

Device: BP blade

Interventions

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.

Colorado microdissection needle group

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.

Cautery group

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.

BP Blade group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients who underwent periodontal therapy in the past 6 months, medically compromised patients, patients with poorly shielded cardiac pacemakers were excluded from the study.

Sponsors & Collaborators

• SVS Institute of Dental Sciences: lead

Study Sites (1)

SVS Institute of Dental Sciences, Mahabubnagar

Hyderabad, Andhra Pradesh, 509002, India

Location

MeSH Terms

Conditions

Periodontitis; Surgical Wound

Interventions

Cautery

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: IEC Secretary

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 28, 2016
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 28, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)