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

Periapical Disease Clinical Trial

Official title:

Effect of Piezoelectric Surgery on Quality of Life and Periradicular Healing After Endodontic Surgery : A Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04358887
• Other study ID #: Dr.Jaya Bharathi
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Periapical Disease
• Periapical Diseases

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