Comparative Evaluation of Two Surgical Blades

NCT04189302 | Unknown DMC

• 1 other identifier: 02_D012_101317
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

this study compares the ease of execution, wound healing and patient morbidity of 2 surgical blade designs.

Conditions

Wound Healing

Outcome Measures

Primary Outcomes (2)

• ease of execution

  it is measured as a time parameter, where the surgical time taken is measured with stop watch

  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

  1 month

Secondary Outcomes (1)

• wound healing

  1 month

Study Arms (2)

palatal connective tissue graft harvest with KPM blade

EXPERIMENTAL

palatal connective tissue graft is harvested using single incision technique using KPM blade

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

Procedure: connective tissue graft harvest using 15 C blade

Interventions

connective tissue graft harvest using KPM blade PROCEDURE

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.

palatal connective tissue graft harvest with KPM blade

connective tissue graft harvest using 15 C blade PROCEDURE

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.

palatal connective tissue graft harvest with 15C blade

Eligibility Criteria

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

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Officials

• Dr. Karthikeyan B.V, MDS

  Krishnadevaraya college of dental sciences , Bangalore ,KARNATAKA , INDIA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Karthikeyan B.V, MDS

CONTACT

9449545157; drkarthikeyanbv@gmaail.com

Dr. Mounika M, MDS

CONTACT

9741971254; mounikagopalarao95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 6, 2019
• Study Start: January 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: December 12, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share