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

NCT ID: NCT04358887

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Periapical Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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periapical surgery with piezo.

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

Group Type EXPERIMENTAL

piezoelectric surgery

Intervention Type PROCEDURE

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

Periapical surgery with bur.

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

Group Type ACTIVE_COMPARATOR

conventional bur

Intervention Type PROCEDURE

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

Interventions

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piezoelectric surgery

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

Intervention Type PROCEDURE

conventional bur

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

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JAYA BHARATHI

Role: PRINCIPAL_INVESTIGATOR

POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK

Locations

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Post graduate institute of dental sciences

Rohtak, Haryana, India

Site Status

Countries

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India

Other Identifiers

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Dr.Jaya Bharathi

Identifier Type: -

Identifier Source: org_study_id

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