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

P

Postgraduate Institute of Dental Sciences Rohtak

Status

Unknown

Conditions

Periapical Disease

Treatments

Procedure: conventional bur
Procedure: piezoelectric surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT04358887
Dr.Jaya Bharathi

Details and patient eligibility

About

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

Full description

The goal of endodontic surgery has changed from mere reduction of periapical pathosis and preservation of periodontium to successful postoperative management of patient regarding function and esthetics, improving the quality of life of patient and their overall acceptance. Piezoelectric bone surgery is a recent and innovative technology, permitting selective cutting of mineralized tissues sparing soft tissues.In this study after thorough clinical & radiographic examination patients will be given informed consent after explaining the treatment procedure and its associated risks and benefits. Patients are allocated into 2 groups, group 1(piezo group) in which after flap reflection bone cutting and root end cutting are performed with US6 piezoelectric insert and in group 2(control) bone and root end cutting are performed with conventional bur. Each patient will be given a questionnaire to fill out for each day starting from the day of surgery for 7 days postoperatively to assess the quality of life. They will be also requested to note down the details of analgesic intake. Hemorrhage control during surgery will be assesed. Clinical and radiographic examinations will be performed every 3, 6 and 12 months to evaluate any evidence of signs and/or symptoms and after 12 month follow up post operative CBCT taken to evaluate volume reduction of lesion postoperatively.

Enrollment

40 estimated patients

Sex

All

Ages

16 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

periapical surgery with piezo.
Experimental group
Description:
After flap reflection bone and root end cutting are done with US6 piezoelectric surgical insert
Treatment:
Procedure: piezoelectric surgery
Periapical surgery with bur.
Active Comparator group
Description:
After flap reflection bone and root end cutting are done with surgical bur.
Treatment:
Procedure: conventional bur

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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