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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04358887
Other study ID # Dr.Jaya Bharathi
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date June 2020

Study information

Verified date April 2020
Source Postgraduate Institute of Dental Sciences Rohtak
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date June 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 60 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
piezoelectric surgery
after flap reflection bone and root end cutting are done with piezoelectric surgical insert
conventional bur
after flap reflection bone and root end cutting are done with surgical bur

Locations

Country Name City State
India Post graduate institute of dental sciences Rohtak Haryana

Sponsors (1)

Lead Sponsor Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life assessment By quality of life questionnaire(Igor Tsesis et al) Till 1 week after surgery
Primary 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 hemorrhage control assessed by scores used by Vy et al during surgery
See also
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Active, not recruiting NCT00228280 - Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling Phase 1/Phase 2