Effect of Piezoelectric Surgery on Quality of Life and Periradicular Healing After Endodontic Surgery

NCT04358887 | Unknown DMC

• 1 other identifier: Dr.Jaya Bharathi
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the effect of piezo Vs bur on quality of life and healing after endodontic surgery.

Conditions

Periapical Disease

Keywords

piezoelectric surgery, quality of life, hemostasis

Outcome Measures

Primary Outcomes (2)

• Quality of life assessment

  By quality of life questionnaire(Igor Tsesis et al)

  Till 1 week after surgery

• Postoperative healing

  2D radiographic healing by Rud et al and Molven et al criteria and 3D healing by modified PENN 3D criteria

  12 months

Secondary Outcomes (1)

• hemorrhage control

  during surgery

Study Arms (2)

periapical surgery with piezo.

EXPERIMENTAL

After flap reflection bone and root end cutting are done with US6 piezoelectric surgical insert

Procedure: piezoelectric surgery

Periapical surgery with bur.

ACTIVE COMPARATOR

After flap reflection bone and root end cutting are done with surgical bur.

Procedure: conventional bur

Interventions

piezoelectric surgery PROCEDURE

after flap reflection bone and root end cutting are done with piezoelectric surgical insert

periapical surgery with piezo.

conventional bur PROCEDURE

after flap reflection bone and root end cutting are done with surgical bur

Periapical surgery with bur.

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with no general medical contra-indications for oral surgical procedures (ASA-1 or ASA-2).
• Patients of age 16 years and above.
• The tooth to be treated surgically should have a periradicular lesion of strictly endodontic origin (chronic apical periodontitis).
• The nonsurgical re-treatment was judged unfeasible or had previously failed.
• The tooth had an adequate final restoration with no clinical evidence of coronal leakage.
• The apical area of the root canal should be devoid of the presence of a post for at least 6 mm.
• Patients with no acute symptoms.

You may not qualify if:

• Unrestorable tooth.
• Fractured / perforated tooth.
• Apicomarginal defects.
• Through \& through lesions.
• Teeth with deep pockets.
• Serious medical illness(uncontrolled/poorly controlled diabetes, unstable or life threatening conditions or requiring antibiotic prophylaxis).

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post graduate institute of dental sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Periapical Diseases

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• JAYA BHARATHI

  POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: December 1, 2018
• Primary Completion: April 30, 2020
• Study Completion: June 1, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)