Wound HealingNCT04189302
Comparative Evaluation of Two Surgical Blades
A study testing connective tissue graft harvest using KPM blade and connective tissue graft harvest using 15 C blade in people with Wound Healing, run by Krishnadevaraya College of Dental Sciences & Hospital.
Trial summary
this study compares the ease of execution, wound healing and patient morbidity of 2 surgical blade designs. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Healing
- What is being tested?
- connective tissue graft harvest using KPM blade and connective tissue graft harvest using 15 C blade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Nov 2021
- Phase
- Interventional
- 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
- Patients willing to participate in the study.
- Patients between age group of 25 to 55 years.
- Systemically healthy subjects.
- Patients with esthetic concerns.
- Patients with palatal mucosa thickness greater than 2.5mm.
- Full mouth plaque score (FMPS) < 20%, Full mouth bleeding score (FMBS) < 20%.
Who cannot join
- Patients with any systemic diseases.
- Patients with history of coagulation disorders.
- Patients with immunological disorders.
- Pregnant and lactating females.
- History of tobacco usage in any form.
- Patients taking medication that interfere with healing.
- Patients with palatal mucosa thickness lesser than 2.5mm.
- Patients who have undergone periodontal surgery within 6 months from the time they enrolled in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Evaluation of Two Surgical Blade Designs to Harvest Palatal Connective Tissue Graft by Single Incision Technique: A Randomized Controlled Clinical Trial
this study compares the ease of execution, wound healing and patient morbidity of 2 surgical blade designs.
Read the detailed description
Over the past few years, connective tissue graft (CTG) is considered as a gold standard and reliable treatment modality in periodontal aesthetic surgeries.Various CTG harvesting techniques have been described which differ in the number of the incisions, flap design, and the technique for gaining access to the graft. Among the numerous techniques for CTG harvest, single incision technique (SIT) proposed by Hurzeler is described as more conservative and least traumatic for the patient. However, there are few limitations of SIT.
To overcome these difficulties, Kumar proposed a special instrument, Barraquer cataract knife and AVS blade to harvest CTG using modified SIT. The Barraquer cataract knife is an ophthalmic blade which is extremely thin and useful in giving mesial and distal incisions of CTG within the limited space under partial thickness flap without tearing it. AVS blade has a terminal shank angled at 100 degrees, with the smooth outer surface and the cutting edge at terminal end perpendicular to the long axis of the instrument which enables placement of medial incision easily without damaging the overlying flap. However, their proposed instrument too had limitations like need for two instruments to, and the straight angulation of the shank makes the adaptation difficult to the palatal vault.
A new instrument KPM blade has been envisaged eliminating these limitations. It has a long thin handle with two contra-angulations of 45degrees and 90degrees on the shank and a terminal shank of ten mm length.This makes the shank easily adapt to any form of the palatal vault, offsets the interference of palatal surfaces of molars and provides a depth control of ten mm in apico-coronal direction without causing any vascular troubles. From the terminal shank blade has a perpendicular projection of two mm which is curved and bevelled which enables it to be used in multidirection with better visibility and good clinical control on incision.
However, till date, this novel KPM blade has not been explored in harvesting CTG using SIT. Thus, the purpose of the present study is to compare KPM blade v/s standard 15c blade to harvest CTG in SIT in terms of ease of harvesting (time), early healing in palatal donor area and patient morbidity.
- Conditions
- Wound Healing
- Being tested
- connective tissue graft harvest using KPM blade, connective tissue graft harvest using 15 C blade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
connective tissue graft harvest using KPM bladeProcedure or surgery
after local anesthesia is injected, the surgical procedure is initiated with 15 C blade and the connective tissue graft is detached from epithelium and underlying periosteum. then the connective tissue is harvested with the help of 2 vertical and 1 horizontal incisions using KPM blade.
connective tissue graft harvest using 15 C bladeProcedure or surgery
after local anesthesia is injected, the surgical procedure is initiated with 15 C blade and the connective tissue graft is detached from epithelium and underlying periosteum. then the connective tissue is harvested with the help of 2 vertical and 1 horizontal incisions using 15C blade.
| Study group | Role | What they receive |
|---|---|---|
| palatal connective tissue graft harvest with KPM blade | Experimental | palatal connective tissue graft is harvested using single incision technique using KPM blade Receives: Procedure: connective tissue graft harvest using KPM blade |
| palatal connective tissue graft harvest with 15C blade | Active comparator | palatal connective tissue graft is harvested using single incision technique using 15 C blade Receives: Procedure: connective tissue graft harvest using 15 C blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
ease of execution
it is measured as a time parameter, where the surgical time taken is measured with stop watch
Measured: 1 month
patient morbidity and postoperative course
a questionnaire will be given to the patients in which their responses for Visual Analog Score that ranges from 1-10 values and highest values indicate the worst outcome, variation in feeding habits, analgesics dosage is recorded. And during baseline and subsequent followups epithelization and bleeding are noted
Measured: 1 month
Secondary outcomes (1)
wound healing
wound healing at palatal donor site is evaluated using modified wound healing index
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study startJan 2020 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Karthikeyan B.V, MDS, Principal investigator, Krishnadevaraya college of dental sciences , Bangalore ,KARNATAKA , INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189302
- Sponsor's protocol ID
- 02_D012_101317
- Status last verified
- Dec 2019
- First submitted
- 4 Dec 2019
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Two Surgical Blade Designs to Harvest Palatal Connective Tissue Graft by Single Incision Technique: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04189302
- Acronym / sponsor ID
- 02_D012_101317
- Conditions
- Wound Healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 6 Dec 2019 (actual)
- 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.
this study compares the ease of execution, wound healing and patient morbidity of 2 surgical blade designs.
Detailed description
Over the past few years, connective tissue graft (CTG) is considered as a gold standard and reliable treatment modality in periodontal aesthetic surgeries.Various CTG harvesting techniques have been described which differ in the number of the incisions, flap design, and the technique for gaining access to the graft. Among the numerous techniques for CTG harvest, single incision technique (SIT) proposed by Hurzeler is described as more conservative and least traumatic for the patient. However, there are few limitations of SIT.
To overcome these difficulties, Kumar proposed a special instrument, Barraquer cataract knife and AVS blade to harvest CTG using modified SIT. The Barraquer cataract knife is an ophthalmic blade which is extremely thin and useful in giving mesial and distal incisions of CTG within the limited space under partial thickness flap without tearing it. AVS blade has a terminal shank angled at 100 degrees, with the smooth outer surface and the cutting edge at terminal end perpendicular to the long axis of the instrument which enables placement of medial incision easily without damaging the overlying flap. However, their proposed instrument too had limitations like need for two instruments to, and the straight angulation of the shank makes the adaptation difficult to the palatal vault.
A new instrument KPM blade has been envisaged eliminating these limitations. It has a long thin handle with two contra-angulations of 45degrees and 90degrees on the shank and a terminal shank of ten mm length.This makes the shank easily adapt to any form of the palatal vault, offsets the interference of palatal surfaces of molars and provides a depth control of ten mm in apico-coronal direction without causing any vascular troubles. From the terminal shank blade has a perpendicular projection of two mm which is curved and bevelled which enables it to be used in multidirection with better visibility and good clinical control on incision.
However, till date, this novel KPM blade has not been explored in harvesting CTG using SIT. Thus, the purpose of the present study is to compare KPM blade v/s standard 15c blade to harvest CTG in SIT in terms of ease of harvesting (time), early healing in palatal donor area and patient morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| palatal connective tissue graft harvest with KPM blade | Experimental | Procedure: connective tissue graft harvest using KPM bladepalatal connective tissue graft is harvested using single incision technique using KPM blade |
| palatal connective tissue graft harvest with 15C blade | Active comparator | Procedure: connective tissue graft harvest using 15 C bladepalatal connective tissue graft is harvested using single incision technique using 15 C blade |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients willing to participate in the study.
- Patients between age group of 25 to 55 years.
- Systemically healthy subjects.
- Patients with esthetic concerns.
- Patients with palatal mucosa thickness greater than 2.5mm.
Key exclusion criteria (8 listed)
- Patients with any systemic diseases.
- Patients with history of coagulation disorders.
- Patients with immunological disorders.
- Pregnant and lactating females.
- History of tobacco usage in any form.
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 |
|---|---|---|
| connective tissue graft harvest using KPM bladeafter local anesthesia is injected, the surgical procedure is initiated with 15 C blade and the connective tissue graft is detached from epithelium and underlying periosteum. then the connective tissue is harvested with the help of 2 vertical and 1 horizontal incisions using KPM blade. | Procedure or surgery | palatal connective tissue graft harvest with KPM blade |
| connective tissue graft harvest using 15 C bladeafter local anesthesia is injected, the surgical procedure is initiated with 15 C blade and the connective tissue graft is detached from epithelium and underlying periosteum. then the connective tissue is harvested with the help of 2 vertical and 1 horizontal incisions using 15C blade. | Procedure or surgery | palatal connective tissue graft harvest with 15C blade |
Primary outcome
ease of execution
Time frame: 1 month
it is measured as a time parameter, where the surgical time taken is measured with stop watch
patient morbidity and postoperative course
Time frame: 1 month
a questionnaire will be given to the patients in which their responses for Visual Analog Score that ranges from 1-10 values and highest values indicate the worst outcome, variation in feeding habits, analgesics dosage is recorded. And during baseline and subsequent followups epithelization and bleeding are noted
1 secondary outcome
wound healing
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Dr. Karthikeyan B.V, MDS principal investigator
Krishnadevaraya college of dental sciences , Bangalore ,KARNATAKA , INDIA
Questions about this trial
What is this clinical trial studying?
A study testing connective tissue graft harvest using KPM blade and connective tissue graft harvest using 15 C blade in people with Wound Healing, run by Krishnadevaraya College of Dental Sciences & Hospital.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Karthikeyan B.V, MDS (9449545157, drkarthikeyanbv@gmaail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ease of execution (time frame: 1 month). The study lists 2 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 12 Dec 2019.