Effect of Piezoelectric Device on Intraoperative Hemorrhage Control and Quality of Life

NCT06240182 | Unknown

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

Brief Summary

Most osteotomies and apicoectomies in periapical surgeries are performed by surgical carbide or diamond burs. But greater pressure is applied during cutting which causes more thermal and mechanical damage to the bone. Also, when it comes in contact with soft tissues like nerves or vessels it results in profuse bleeding which affects vision in surgery and neurosensory disturbance at a later stage along with the deposition of metal shavings and bony particles resulting in impaired healing. The main advantages of piezoelectric surgery in various studies are highlighted as selective hard tissue cutting and sparing soft tissue, so even if it comes in contact with vessels, nerve or Schneiderian membrane it does not result in profuse bleeding, postoperative nerve damage or perforation.

Conditions

Periapical Lesion

Outcome Measures

Primary Outcomes (2)

• Quality of life assessment

  to assess pain, swelling, mouth opening and effect on daily activities of patient among piezosurgery and conventional surgery using patient perception questionnaire aon, swelling, mouth opening and any effect on

  till 7 days after surgery

• hemorrhage control

  to assess intraoperative hemorrhage control among 2 groups

  During surgery

Secondary Outcomes (1)

• periapical healing

  Base line to 12 months

Study Arms (2)

Conventional surgery

ACTIVE COMPARATOR

performing surgery by surgical carbide burs

Procedure: conventional surgery

Piezoelectric surgery

EXPERIMENTAL

surgery performed using piezoelectric device

Procedure: piezoelectric device

Interventions

conventional surgery PROCEDURE

Surgery performed using conventional rotary burs

Conventional surgery

piezoelectric device PROCEDURE

surgery performed using piezoelectric device.

Piezoelectric surgery

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients between 16-55 years of age
• ASA-1 or ASA- 2 according to the classification of the American Society of Anesthesiologists)
• Peri radicular lesion of strictly endodontic origin with size of lesion ≥ 5mm in CBCT
• non-surgical retreatment unfeasible (post, anatomical complexity, iatrogenic errors) or previously failed treatment.
• Good periodontal health condition at tooth level.
• Able to completely understand and sign an informed consent form.

You may not qualify if:

• Presence of vertical root fracture
• Presence of root perforations
• Miller class III/IV mobility
• Presence of root resorption
• Combined endodontic-periodontic lesions.
• Pregnancy

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

Location

Study Officials

• DR. Sanjay Tewari, MDS

  PGIDS,Rohtak, Haryana, 124001

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sham piezoelectric setup for patients undergoing conventional surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 2, 2024
• Study Start: November 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01

Locations

IN (1)