Periapical LesionsNCT06587048
Outcome of Bone Window Approach in Endodontic Microsurgery Using Novel Piezoelectric Device
A study testing periapical surgery in people with Periapical Lesions and Chronic Apical Periodontitis of Pulpal Origin, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
The Bone window technique provides excellent access to the surgical site while preserving cortical bone in cases of tooth with large periapical lesion and an intact cortical plate. Traditionally, rotary burs and a bone chisel were used to create a bone window. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Periapical Lesions, Chronic Apical Periodontitis of Pulpal Origin
- What is being tested?
- periapical surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2023to 1 May 2025
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Consenting adults (age range: 18-60 years)
- Non-contributory medical history (ASA Class I or Class 2)
- Participants with symptomatic/persistent apical periodontitis showing clinical signs and symptoms and evidence of periapical lesion of strictly endodontic origin with minimum lesion diameter of 5mm on periapical radiography (PR).
- Radiographic evidence of an intact buccal cortical plate on cone-beam computed tomographic (CBCT) imaging with minimum thickness of 1mm.
Who cannot join
- Patients with systemic diseases (diabetes mellitus, uncontrolled hypertension, hepatic/renal disease, or systemic bleeding disorders), pregnancy, smoking
- Patients on anticoagulant/ antiplatelet drugs
- Teeth that were unrestorable, fractured/perforated teeth,
- Teeth with endodontic-periodontal communication and
- Teeth with deep pockets (probing depth \>4 mm)
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
Sanjay Tewari, MDS, 9416259534, tewarisanjayrohtak@yahoo.co.in
keerthana G, MDS, 9789502701, keerthuguru94@gmail.com
About this study
Official title: Outcome of Bone Window Approach in Endodontic Microsurgery Using Novel Piezoelectric Device Versus Conventional Rotary Burs in the Treatment of Periapical Lesions - a Randomized Controlled Trial
The Bone window technique provides excellent access to the surgical site while preserving cortical bone in cases of tooth with large periapical lesion and an intact cortical plate. Traditionally, rotary burs and a bone chisel were used to create a bone window. Piezoelectric bone surgery, on the other hand, is an innovative technique that uses thin osteotomy instrument to selectively cut hard tissue while preserving soft tissues. To the best of our knowledge, no study comparing the results of a bone lid using a piezoelectric device and a conventional bur is currently available.
Read the detailed description
Endodontic microsurgery is the treatment option frequently opted to manage endodontically failed cases with persistent apical periodontitis, after nonsurgical root canal treatment (1,2). Contemporary surgical endodontic therapy using dental operating microscope enables a more precise technique with no or little bevel of root-end excision and retrograde canal preparation with an ultrasonic tip to a depth of 3-4 mm (3). The cumulative loss of cortical bone may further result in slowed or unsuccessful healing at the surgical site as a result of the disease process and/or the removal of cortical plates during a surgical procedure (4,5). According to the animal histologic sections, the cortical plate heals slowest, with a 70% healing rate at the 6-month follow-up. Von Arx et al reported that only 54.1% of patients demonstrated complete cortical plate healing at the end of one-year follow-up when assessed by cone-beam computed tomography (CBCT) (6). The degree of cortical plate loss and its limited capacity for regeneration may necessitate the use of regenerative methods involving graft materials.
A novel and minimally invasive procedure called the bone window approach to the apical region aims to preserve more bony structure and the structural integrity of the healthy cortical plate. The bone window also functions as autologous graft material, which has been recognized as the gold standard for regeneration without the need for additional substitute materials (7,8). For obtaining bone window, use of traditional burs in combination with chisels, reciprocating or oscillating saws and lasers have been reported in literature. Piezoelectric bone surgery is an innovative technology that has gained popularity in recent years. It makes use of thin osteotomy instruments that enable selective hard tissue cutting while safeguarding soft tissues (9). This technique is not only clinically effective, but histological and histomorphometric evidence of wound healing and bone formation in experimental animal models has shown that tissue response is better in piezo surgery than in conventional bone-cutting techniques such as diamond or carbide rotary instruments (10-12).
In cases of large periapical lesions where the buccal cortical plate is intact, the application of the piezoelectric device has recently been reported in case reports to create a bony window on buccal bone (13, 14). In a recent randomized trial (15), piezo surgery was compared to traditional microsurgery to assess haemorrhage control and patient postoperative quality of life. In a recent randomized trial (16) comparing bone lid technique over traditional technique in the surgical management of mandibular lesions, the bone lid technique using a piezoelectric device was found to be safe and effective for treating lesions in the posterior mandibular region and was associated with less postoperative complications. The bone lid approach has been used in the literature on oral and maxillofacial surgery for a number of procedures, including root-end surgery, cystic enucleation, impacted tooth extraction, implant explantation, and access to the maxillary sinus for the removal of cysts or foreign bodies. The review concluded that the included clinical studies were of low quality evidence, and that randomized clinical trials were necessary to compare the effectiveness of the bone lid technique to other methods. Furthermore, the best cutting tool for fashioning bone lids has not yet been identified (17).
The transition of endodontic diagnosis and treatment planning from two dimensions to three dimensions is facilitated by CBCT scanning, which also shows the location of anatomical structures in three dimensions, provides precise measurements in depth and length, and enhances localization of the periapical lesion (18, 19). Furthermore, CBCT imaging has high sensitivity to detect the presence of a bony defect in the cortical plate and precisely measure its thickness (20, 21, 22).
- Being tested
- periapical surgery
- Keywords
- endondontic microsurgery, piezoelectric device, piezoendodontic surgery, bone window
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periapical surgeryProcedure or surgery
In piezo group, the periapical surgery will be performed using piezoelectric device.
periapical surgeryProcedure or surgery
In conventional bur group, the periapical surgery will be performed using rotary burs.
| Study group | Role | What they receive |
|---|---|---|
| Piezo group | Experimental | The bone window osteotomy will be created with a piezoelectric device during endodontic microsurgery Receives: Procedure: periapical surgery |
| conventional bur group | Active comparator | The bone window osteotomy will be created with a conventional rotary burs in slow-speed handpiece during endodontic microsurgery Receives: Procedure: periapical surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical assessment
All patients will undergo surgical evaluation 24 h, 48h, 72 h, one week, six months and 12 months after the surgery. Postsurgical pain was measured using the VAS scale.
Measured: 1 year after surgery
Radiographic outcome
CBCT will be performed 12 months postoperatively, and the findings will be compared with preoperative CBCT findings to assess the bone defect fill and cortical plate formation using modified PENN 3D criteria and RAC index
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical LesionsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjay Tewari, Postgraduate Institute of Dental Sciences Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587048
- Sponsor's protocol ID
- keerthana
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Bone Window Approach in Endodontic Microsurgery Using Novel Piezoelectric Device Versus Conventional Rotary Burs in the Treatment of Periapical Lesions - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06587048
- Acronym / sponsor ID
- keerthana
- Keywords
- endondontic microsurgery, piezoelectric device, piezoendodontic surgery, bone window
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 19 Sep 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.
The Bone window technique provides excellent access to the surgical site while preserving cortical bone in cases of tooth with large periapical lesion and an intact cortical plate. Traditionally, rotary burs and a bone chisel were used to create a bone window. Piezoelectric bone surgery, on the other hand, is an innovative technique that uses thin osteotomy instrument to selectively cut hard tissue while preserving soft tissues. To the best of our knowledge, no study comparing the results of a bone lid using a piezoelectric device and a conventional bur is currently available.
Detailed description
Endodontic microsurgery is the treatment option frequently opted to manage endodontically failed cases with persistent apical periodontitis, after nonsurgical root canal treatment (1,2). Contemporary surgical endodontic therapy using dental operating microscope enables a more precise technique with no or little bevel of root-end excision and retrograde canal preparation with an ultrasonic tip to a depth of 3-4 mm (3). The cumulative loss of cortical bone may further result in slowed or unsuccessful healing at the surgical site as a result of the disease process and/or the removal of cortical plates during a surgical procedure (4,5). According to the animal histologic sections, the cortical plate heals slowest, with a 70% healing rate at the 6-month follow-up. Von Arx et al reported that only 54.1% of patients demonstrated complete cortical plate healing at the end of one-year follow-up when assessed by cone-beam computed tomography (CBCT) (6). The degree of cortical plate loss and its limited capacity for regeneration may necessitate the use of regenerative methods involving graft materials.
A novel and minimally invasive procedure called the bone window approach to the apical region aims to preserve more bony structure and the structural integrity of the healthy cortical plate. The bone window also functions as autologous graft material, which has been recognized as the gold standard for regeneration without the need for additional substitute materials (7,8). For obtaining bone window, use of traditional burs in combination with chisels, reciprocating or oscillating saws and lasers have been reported in literature. Piezoelectric bone surgery is an innovative technology that has gained popularity in recent years. It makes use of thin osteotomy instruments that enable selective hard tissue cutting while safeguarding soft tissues (9). This technique is not only clinically effective, but histological and histomorphometric evidence of wound healing and bone formation in experimental animal models has shown that tissue response is better in piezo surgery than in conventional bone-cutting techniques such as diamond or carbide rotary instruments (10-12).
In cases of large periapical lesions where the buccal cortical plate is intact, the application of the piezoelectric device has recently been reported in case reports to create a bony window on buccal bone (13, 14). In a recent randomized trial (15), piezo surgery was compared to traditional microsurgery to assess haemorrhage control and patient postoperative quality of life. In a recent randomized trial (16) comparing bone lid technique over traditional technique in the surgical management of mandibular lesions, the bone lid technique using a piezoelectric device was found to be safe and effective for treating lesions in the posterior mandibular region and was associated with less postoperative complications. The bone lid approach has been used in the literature on oral and maxillofacial surgery for a number of procedures, including root-end surgery, cystic enucleation, impacted tooth extraction, implant explantation, and access to the maxillary sinus for the removal of cysts or foreign bodies. The review concluded that the included clinical studies were of low quality evidence, and that randomized clinical trials were necessary to compare the effectiveness of the bone lid technique to other methods. Furthermore, the best cutting tool for fashioning bone lids has not yet been identified (17).
The transition of endodontic diagnosis and treatment planning from two dimensions to three dimensions is facilitated by CBCT scanning, which also shows the location of anatomical structures in three dimensions, provides precise measurements in depth and length, and enhances localization of the periapical lesion (18, 19). Furthermore, CBCT imaging has high sensitivity to detect the presence of a bony defect in the cortical plate and precisely measure its thickness (20, 21, 22).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piezo group | Experimental | Procedure: periapical surgeryThe bone window osteotomy will be created with a piezoelectric device during endodontic microsurgery |
| conventional bur group | Active comparator | Procedure: periapical surgeryThe bone window osteotomy will be created with a conventional rotary burs in slow-speed handpiece during endodontic microsurgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Consenting adults (age range: 18-60 years)
Key exclusion criteria (5 listed)
- Patients with systemic diseases (diabetes mellitus, uncontrolled hypertension, hepatic/renal disease, or systemic bleeding disorders), pregnancy, smoking
- Patients on anticoagulant/ antiplatelet drugs
- Teeth that were unrestorable, fractured/perforated teeth,
- Teeth with endodontic-periodontal communication and
- Teeth with deep pockets (probing depth \>4 mm)
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 |
|---|---|---|
| periapical surgeryIn piezo group, the periapical surgery will be performed using piezoelectric device. | Procedure or surgery | Piezo group |
| periapical surgeryIn conventional bur group, the periapical surgery will be performed using rotary burs. | Procedure or surgery | conventional bur group |
Primary outcome
clinical assessment
Time frame: 1 year after surgery
All patients will undergo surgical evaluation 24 h, 48h, 72 h, one week, six months and 12 months after the surgery. Postsurgical pain was measured using the VAS scale.
Radiographic outcome
Time frame: 1 year after surgery
CBCT will be performed 12 months postoperatively, and the findings will be compared with preoperative CBCT findings to assess the bone defect fill and cortical plate formation using modified PENN 3D criteria and RAC index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing periapical surgery in people with Periapical Lesions and Chronic Apical Periodontitis of Pulpal Origin, 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 4 inclusion and 5 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 19 Sep 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?
Contact sanjay tewari, MDS conservative dentistry 941 (9416259534, tewarisanjayrohtak@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical assessment (time frame: 1 year 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 19 Sep 2024.