Effect of Piezoelectric Surgery on Quality of Life and Periradicular Healing After Endodontic Surgery
Primary Purpose
Periapical Disease
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
piezoelectric surgery
conventional bur
Sponsored by
About this trial
This is an interventional treatment trial for Periapical Disease focused on measuring piezoelectric surgery, quality of life, hemostasis
Eligibility Criteria
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).
Sites / Locations
- Post graduate institute of dental sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
periapical surgery with piezo.
Periapical surgery with bur.
Arm Description
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 surgical bur.
Outcomes
Primary Outcome Measures
Quality of life assessment
By quality of life questionnaire(Igor Tsesis et al)
Postoperative healing
2D radiographic healing by Rud et al and Molven et al criteria and 3D healing by modified PENN 3D criteria
Secondary Outcome Measures
hemorrhage control
assessed by scores used by Vy et al
Full Information
NCT ID
NCT04358887
First Posted
April 21, 2020
Last Updated
April 21, 2020
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
1. Study Identification
Unique Protocol Identification Number
NCT04358887
Brief Title
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
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Disease
Keywords
piezoelectric surgery, quality of life, hemostasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
periapical surgery with piezo.
Arm Type
Experimental
Arm Description
After flap reflection bone and root end cutting are done with US6 piezoelectric surgical insert
Arm Title
Periapical surgery with bur.
Arm Type
Active Comparator
Arm Description
After flap reflection bone and root end cutting are done with surgical bur.
Intervention Type
Procedure
Intervention Name(s)
piezoelectric surgery
Intervention Description
after flap reflection bone and root end cutting are done with piezoelectric surgical insert
Intervention Type
Procedure
Intervention Name(s)
conventional bur
Intervention Description
after flap reflection bone and root end cutting are done with surgical bur
Primary Outcome Measure Information:
Title
Quality of life assessment
Description
By quality of life questionnaire(Igor Tsesis et al)
Time Frame
Till 1 week after surgery
Title
Postoperative healing
Description
2D radiographic healing by Rud et al and Molven et al criteria and 3D healing by modified PENN 3D criteria
Time Frame
12 months
Secondary Outcome Measure Information:
Title
hemorrhage control
Description
assessed by scores used by Vy et al
Time Frame
during surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JAYA BHARATHI
Organizational Affiliation
POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Post graduate institute of dental sciences
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Piezoelectric Surgery on Quality of Life and Periradicular Healing After Endodontic Surgery
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