PeriodontitisPhase 3NCT03003624
Comparing the Outcomes of Incisions Made by Colorado® Microdissection Needle
A Phase 3 study testing Colorado® microdissection needle, Cautery tip and BP blade in people with Periodontitis, run by SVS Institute of Dental Sciences at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Colorado® microdissection needle, Cautery tip and BP blade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2015to Aug 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients who underwent periodontal therapy in the past 6 months, medically compromised patients, patients with poorly shielded cardiac pacemakers were excluded from the study.
Trial locations and contacts
1 site in 1 country.
India1 site
SVS Institute of Dental Sciences, Mahabubnagar
Hyderabad, Andhra Pradesh, 509002
About this study
Official title: Comparing the Outcomes Of Incisions Made By Colorado® Microdissection Needle, Electrosurgery Tip And Surgical Blade During Periodontal Surgery
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.
Read the 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.
- Conditions
- Periodontitis
- Being tested
- Colorado® microdissection needle, Cautery tip, BP blade
- Keywords
- Incisions, microdissection needle
- Medical subject headings
- Periodontitis, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorado® microdissection needleDevice
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 tipDevice
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 bladeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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), Receives: Device: Colorado® microdissection needle |
| Cautery group | Experimental | Electrosurgery tip was used to give incisions. Receives: Device: Cautery tip |
| BP Blade group | Active comparator | No.15 surgical blade was used to give incisions. Receives: Device: BP blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of blood loss in ml
Quantity of blood loss by swab weighing method.
Measured: 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.
Measured: Baseline to 180 days
Changes in dimensions of interdental papilla in mm
Changes in dimensions of interdental papilla using a periodontal probe.
Measured: Baseline to 180 days
Secondary outcomes (2)
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.
Measured: 1 day, 7 & 15 days
Assessment of wound healing:
Wound healing was recorded using Early wound healing index (EHI).
Measured: 1 day, 7 & 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- SVS Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr R Viswa Chandra, SVS Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003624
- Sponsor's protocol ID
- SVSIEC
- Status last verified
- Dec 2016
- First submitted
- 20 Dec 2016
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Publication data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Outcomes Of Incisions Made By Colorado® Microdissection Needle, Electrosurgery Tip And Surgical Blade During Periodontal Surgery
- ClinicalTrials.gov ID
- NCT03003624
- Acronym / sponsor ID
- SVSIEC
- Conditions
- Periodontitis
- Keywords
- Incisions, microdissection needle
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SVS Institute of Dental SciencesUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Colorado microdissection needle group | Experimental | Device: Colorado® microdissection needleIn 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 | Experimental | Device: Cautery tipElectrosurgery tip was used to give incisions. |
| BP Blade group | Active comparator | Device: BP bladeNo.15 surgical blade was used to give incisions. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who underwent periodontal therapy in the past 6 months, medically compromised patients, patients with poorly shielded cardiac pacemakers were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colorado® microdissection needleThe 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. | Device | Colorado microdissection needle group |
| Cautery tipStudies 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. | Device | Cautery group |
| BP bladeStudies 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. | Device | BP Blade group |
Primary outcome
Quantity of blood loss in ml
Time frame: Immediate postoperative volume
Quantity of blood loss by swab weighing method.
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.
Changes in dimensions of interdental papilla in mm
Time frame: Baseline to 180 days
Changes in dimensions of interdental papilla using a periodontal probe.
2 secondary outcomes
Assessment of postoperative pain:
Time frame: 1 day, 7 & 15 days
Assessment of wound healing:
Time frame: 1 day, 7 & 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
- Individual participant dataSharing planned: No. Publication data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colorado® microdissection needle, Cautery tip and BP blade in people with Periodontitis, run by SVS Institute of Dental Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of blood loss in ml (time frame: Immediate postoperative volume). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2016.