- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04358887
Effect of Piezoelectric Surgery on Quality of Life and Periradicular Healing After Endodontic Surgery
April 21, 2020 updated by: Postgraduate Institute of Dental Sciences Rohtak
Effect of Piezoelectric Surgery on Quality of Life and Periradicular Healing After Endodontic Surgery : A Randomized Clinical Trial
This study will compare the effect of piezo Vs bur on quality of life and healing after endodontic surgery.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Haryana
-
Rohtak, Haryana, India, 124001
- Post Graduate Institute of Dental Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with no general medical contra-indications for oral surgical procedures (ASA-1 or ASA-2).
- Patients of age 16 years and above.
- The tooth to be treated surgically should have a periradicular lesion of strictly endodontic origin (chronic apical periodontitis).
- The nonsurgical re-treatment was judged unfeasible or had previously failed.
- The tooth had an adequate final restoration with no clinical evidence of coronal leakage.
- The apical area of the root canal should be devoid of the presence of a post for at least 6 mm.
- Patients with no acute symptoms.
Exclusion Criteria:
- Unrestorable tooth.
- Fractured / perforated tooth.
- Apicomarginal defects.
- Through & through lesions.
- Teeth with deep pockets.
- Serious medical illness(uncontrolled/poorly controlled diabetes, unstable or life threatening conditions or requiring antibiotic prophylaxis).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: periapical surgery with piezo.
After flap reflection bone and root end cutting are done with US6 piezoelectric surgical insert
|
after flap reflection bone and root end cutting are done with piezoelectric surgical insert
|
Active Comparator: Periapical surgery with bur.
After flap reflection bone and root end cutting are done with surgical bur.
|
after flap reflection bone and root end cutting are done with surgical bur
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life assessment
Time Frame: Till 1 week after surgery
|
By quality of life questionnaire(Igor Tsesis et al)
|
Till 1 week after surgery
|
Postoperative healing
Time Frame: 12 months
|
2D radiographic healing by Rud et al and Molven et al criteria and 3D healing by modified PENN 3D criteria
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hemorrhage control
Time Frame: during surgery
|
assessed by scores used by Vy et al
|
during surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: JAYA BHARATHI, Post graduate institute of dental sciences, Rohtak
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2018
Primary Completion (Anticipated)
April 30, 2020
Study Completion (Anticipated)
June 1, 2020
Study Registration Dates
First Submitted
April 21, 2020
First Submitted That Met QC Criteria
April 21, 2020
First Posted (Actual)
April 24, 2020
Study Record Updates
Last Update Posted (Actual)
April 24, 2020
Last Update Submitted That Met QC Criteria
April 21, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dr.Jaya Bharathi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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