Periapical LesionNCT06240182
Effect of Piezoelectric Device on Intraoperative Hemorrhage Control and Quality of Life
A study testing conventional surgery and piezoelectric device in people with Periapical Lesion, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Most osteotomies and apicoectomies in periapical surgeries are performed by surgical carbide or diamond burs. But greater pressure is applied during cutting which causes more thermal and mechanical damage to the bone. Read more about this study
- Who is it for?
- Ages 16 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Lesion
- What is being tested?
- conventional surgery and piezoelectric device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2022to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Presence of vertical root fracture
- Presence of root perforations
- Miller class III/IV mobility
- Presence of root resorption
- Combined endodontic-periodontic lesions.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Piezoelectric Device on Intraoperative Hemorrhage Control and Quality of Life After Endodontic Microsurgery in Maxillary Molar Teeth: a Randomized Controlled Trial
Most osteotomies and apicoectomies in periapical surgeries are performed by surgical carbide or diamond burs. But greater pressure is applied during cutting which causes more thermal and mechanical damage to the bone. Also, when it comes in contact with soft tissues like nerves or vessels it results in profuse bleeding which affects vision in surgery and neurosensory disturbance at a later stage along with the deposition of metal shavings and bony particles resulting in impaired healing. The main advantages of piezoelectric surgery in various studies are highlighted as selective hard tissue cutting and sparing soft tissue, so even if it comes in contact with vessels, nerve or Schneiderian membrane it does not result in profuse bleeding, postoperative nerve damage or perforation.
Read the 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.
- Conditions
- Periapical Lesion
- Being tested
- conventional surgery, piezoelectric device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional surgeryProcedure or surgery
Surgery performed using conventional rotary burs
piezoelectric deviceProcedure or surgery
surgery performed using piezoelectric device.
| Study group | Role | What they receive |
|---|---|---|
| Conventional surgery | Active comparator | performing surgery by surgical carbide burs Receives: Procedure: conventional surgery |
| Piezoelectric surgery | Experimental | surgery performed using piezoelectric device Receives: Procedure: piezoelectric device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life assessment
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
Measured: till 7 days after surgery
hemorrhage control
to assess intraoperative hemorrhage control among 2 groups
Measured: During surgery
Secondary outcomes (1)
periapical healing
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
Measured: Base line to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Nov 2022
- Primary completion1 Apr 2023
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical LesionStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DR. Sanjay Tewari, MDS, Study director, PGIDS,Rohtak, Haryana, 124001
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240182
- Sponsor's protocol ID
- Yamini kindra
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Piezoelectric Device on Intraoperative Hemorrhage Control and Quality of Life After Endodontic Microsurgery in Maxillary Molar Teeth: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06240182
- Acronym / sponsor ID
- Yamini kindra
- Conditions
- Periapical Lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most osteotomies and apicoectomies in periapical surgeries are performed by surgical carbide or diamond burs. But greater pressure is applied during cutting which causes more thermal and mechanical damage to the bone. Also, when it comes in contact with soft tissues like nerves or vessels it results in profuse bleeding which affects vision in surgery and neurosensory disturbance at a later stage along with the deposition of metal shavings and bony particles resulting in impaired healing. The main advantages of piezoelectric surgery in various studies are highlighted as selective hard tissue cutting and sparing soft tissue, so even if it comes in contact with vessels, nerve or Schneiderian membrane it does not result in profuse bleeding, postoperative nerve damage or perforation.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional surgery | Active comparator | Procedure: conventional surgeryperforming surgery by surgical carbide burs |
| Piezoelectric surgery | Experimental | Procedure: piezoelectric devicesurgery performed using piezoelectric device |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- Presence of vertical root fracture
- Presence of root perforations
- Miller class III/IV mobility
- Presence of root resorption
- Combined endodontic-periodontic lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional surgerySurgery performed using conventional rotary burs | Procedure or surgery | Conventional surgery |
| piezoelectric devicesurgery performed using piezoelectric device. | Procedure or surgery | Piezoelectric surgery |
Primary outcome
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
hemorrhage control
Time frame: During surgery
to assess intraoperative hemorrhage control among 2 groups
1 secondary outcome
periapical healing
Time frame: Base line to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DR. Sanjay Tewari, MDS study director
PGIDS,Rohtak, Haryana, 124001
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional surgery and piezoelectric device in people with Periapical Lesion, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life assessment (time frame: till 7 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.