Clinical trial NCT04189302: Comparative Evaluation of Two Surgical Blades
Official title: Comparative Evaluation of Two Surgical Blade Designs to Harvest Palatal Connective Tissue Graft by Single Incision Technique: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound Healing
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients willing to participate in the study.
2. Patients between age group of 25 to 55 years.
3. Systemically healthy subjects.
4. Patients with esthetic concerns.
5. Patients with palatal mucosa thickness greater than 2.5mm.
6. Full mouth plaque score (FMPS) \< 20%, Full mouth bleeding score (FMBS) \< 20%.

Exclusion Criteria:

1. Patients with any systemic diseases.
2. Patients with history of coagulation disorders.
3. Patients with immunological disorders.
4. Pregnant and lactating females.
5. History of tobacco usage in any form.
6. Patients taking medication that interfere with healing.
7. Patients with palatal mucosa thickness lesser than 2.5mm.
8. Patients who have undergone periodontal surgery within 6 months from the time they enrolled in the study.

Primary outcomes:
measure: ease of execution
timeFrame: 1 month
measure: patient morbidity and postoperative course
timeFrame: 1 month
Secondary outcomes:
measure: wound healing
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Krishnadevaraya college of dental sciences , Bangalore ,KARNATAKA , INDIA
name: Dr. Karthikeyan B.V, MDS
role: PRINCIPAL_INVESTIGATOR
References: