Clinical trial NCT04358887: Effect of Piezoelectric Surgery on Quality of Life and Periradicular Healing After Endodontic Surgery
Official title: Effect of Piezoelectric Surgery on Quality of Life and Periradicular Healing After Endodontic Surgery : A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periapical Disease
Keywords: piezoelectric surgery, quality of life, hemostasis
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Quality of life assessment
timeFrame: Till 1 week after surgery
measure: Postoperative healing
timeFrame: 12 months
Secondary outcomes:
measure: hemorrhage control
timeFrame: during surgery
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post graduate institute of dental sciences
state: Haryana
Study officials:
affiliation: POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK
name: JAYA BHARATHI
role: PRINCIPAL_INVESTIGATOR
References: