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

Not Applicable

• Conditions: Periapical Disease
• Interventions: Procedure: conventional bur; Procedure: piezoelectric surgery

• Registration Number: NCT04358887
• Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-12-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-21
• Last Update Submitted: 2020-04-21
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24
• Primary Completion: 2020-04-30
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periapical surgery with bur.	conventional bur	After flap reflection bone and root end cutting are done with surgical bur.
periapical surgery with piezo.	piezoelectric surgery	After flap reflection bone and root end cutting are done with US6 piezoelectric surgical insert

Primary Outcome Measures

Name	Time	Method
Quality of life assessment	Till 1 week after surgery	By quality of life questionnaire(Igor Tsesis et al)
Postoperative healing	12 months	2D radiographic healing by Rud et al and Molven et al criteria and 3D healing by modified PENN 3D criteria

Secondary Outcome Measures

Name	Time	Method
hemorrhage control	during surgery	assessed by scores used by Vy et al

Trial Locations

Locations (1)

Post graduate institute of dental sciences; 🇮🇳 Rohtak, Haryana, India