- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06240182
Effect of Piezoelectric Device on Intraoperative Hemorrhage Control and Quality of Life
Effect of Piezoelectric Device on Intraoperative Hemorrhage Control and Quality of Life After Endodontic Microsurgery in Maxillary Molar Teeth: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Most periapical radiolucent lesions heal uneventfully after endodontic treatment. However, some cases may require periradicular surgery in order to remove pathologic tissue from the periapical region and simultaneously eliminate any source of irritation that could not be removed by orthograde root canal treatment
In dentistry, the piezoelectric bone surgery was developed by the oral surgeon Tomaso Vercellotti in 1988, to overcome the limitations of traditional instrumentation, which was first used for maxillary sinus surgery to reduce the incidence of Schneiderian membrane perforations.
Piezoelectric surgery is a promising technical modality with applications in several aspects of endodontic surgery like bone-tissue management, enucleation of radicular cysts, root-end resection & root-end Cavity Preparation. Piezoelectric surgical device operates with principles similar to the piezoelectric dental scaler devices except for its power which is three to six times higher than the piezoelectric dental scalers. The advantages of piezoelectric surgery over conventional endodontic surgery include protection of soft tissues, optimal visualization of the surgical field, decreased blood loss, reduced vibration and noise, increased patient comfort and protection of tooth structures. But some of its disadvantages are initial financial burden for setting up of the unit, long duration of surgery and instruction manuals discouraging its use in patients with cardiac pacemakers.
Less intraoperative blood loss and less chance of inferior alveolar nerve injury was observed on piezoelectric osteotomy in orthognathic surgery at no extra time investment.
In a similar study comparing piezo osteotomy and traditional saw in bimaxillary orthognathic surgery there was significantly reduced blood loss, postoperative hematoma, swelling and nerve impairment in piezo osteotomy but the mean operative time was more
Distance of 1.97mm between the maxillary sinus floor and root apices and even shorter distance between the periapical lesion and maxillary sinus floor warns the surgeon during removal of lesion.
Schneiderian membrane perforation rate while performing lateral window sinus elevation procedure reduced from 30% by conventional surgical burs to 7% by piezoelectric unit.
The capacity of selective cutting, reducing the risk of perforating the sinus lining, and increased visibility of the surgical field due to the cavitation effect from the saline irrigating solution of the piezoelectric unit makes it the preferred option for performing upper molar surgery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Haryana
-
Rohtak, Haryana, India, 124001
- PGIDS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Patients between 16-55 years of age
- ASA-1 or ASA- 2 according to the classification of the American Society of Anesthesiologists)
- Peri radicular lesion of strictly endodontic origin with size of lesion ≥ 5mm in CBCT
- non-surgical retreatment unfeasible (post, anatomical complexity, iatrogenic errors) or previously failed treatment.
- Good periodontal health condition at tooth level.
- Able to completely understand and sign an informed consent form.
Exclusion criteria:
- Presence of vertical root fracture
- Presence of root perforations
- Miller class III/IV mobility
- Presence of root resorption
- Combined endodontic-periodontic lesions.
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Conventional surgery
performing surgery by surgical carbide burs
|
Surgery performed using conventional rotary burs
|
Experimental: Piezoelectric surgery
surgery performed using piezoelectric device
|
surgery performed using piezoelectric device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life assessment
Time Frame: till 7 days after surgery
|
to assess pain, swelling, mouth opening and effect on daily activities of patient among piezosurgery and conventional surgery using patient perception questionnaire aon, swelling, mouth opening and any effect on |
till 7 days after surgery
|
hemorrhage control
Time Frame: During surgery
|
to assess intraoperative hemorrhage control among 2 groups
|
During surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
periapical healing
Time Frame: Base line to 12 months
|
periapical healing comparison in 2 groups 2D radiographic healing by Rud et al and Molven et al criteria and 3D healing by modified PENN 3D criteria
|
Base line to 12 months
|
Collaborators and Investigators
Investigators
- Study Director: DR. Sanjay Tewari, MDS, PGIDS,Rohtak, Haryana, 124001
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Yamini kindra
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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