Effect of Piezoelectric Surgery on Quality of Life and Pe... | NCT04358887

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

NCT04358887

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Status

Unknown status

Last Update Posted

Apr 24, 2020Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Periapical Disease

Interventions

piezoelectric surgery
conventional bur

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2018Actual

Primary Completion Date

Apr 30, 2020Estimated

Completion Date

Jun 2020Estimated

First Submitted Date

Apr 21, 2020

First Submission Date that Met QC Criteria

Apr 21, 2020

First Posted Date

Apr 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2020

Last Update Posted Date

Apr 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
periapical surgery with piezo.	Experimental	After flap reflection bone and root end cutting are done with US6 piezoelectric surgical insert	Procedure: piezoelectric surgery
Periapical surgery with bur.	Active Comparator	After flap reflection bone and root end cutting are done with surgical bur.	Procedure: conventional bur

Interventions

Name	Type	Description	Arm Group Labels	Other Names
piezoelectric surgery	Procedure	after flap reflection bone and root end cutting are done with piezoelectric surgical insert	periapical surgery with piezo.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life assessment	By quality of life questionnaire(Igor Tsesis et al)	Till 1 week after surgery
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 Outcomes

Measure	Description	Time Frame
hemorrhage control	assessed by scores used by Vy et al	during surgery

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
JAYA BHARATHI	POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Post graduate institute of dental sciences		Rohtak	Haryana	124001	India

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010483	Periapical Diseases

Ancestor Terms

ID	Term
D007571	Jaw Diseases
D009057	Stomatognathic Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided