Periapical DiseaseNCT04358887
Effect of Piezoelectric Surgery on Quality of Life and Periradicular Healing After Endodontic Surgery
A study testing piezoelectric surgery and conventional bur in people with Periapical Disease, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
This study will compare the effect of piezo Vs bur on quality of life and healing after endodontic surgery. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Disease
- What is being tested?
- piezoelectric surgery and conventional bur
- 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 Dec 2018to Jun 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Piezoelectric Surgery on Quality of Life and Periradicular Healing After Endodontic Surgery : A Randomized Clinical Trial
This study will compare the effect of piezo Vs bur on quality of life and healing after endodontic surgery.
Read the 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.
- Conditions
- Periapical Disease
- Being tested
- piezoelectric surgery, conventional bur
- Keywords
- piezoelectric surgery, quality of life, hemostasis
- Medical subject headings
- Periapical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
piezoelectric surgeryProcedure or surgery
after flap reflection bone and root end cutting are done with piezoelectric surgical insert
conventional burProcedure or surgery
after flap reflection bone and root end cutting are done with surgical bur
| Study group | Role | What they receive |
|---|---|---|
| periapical surgery with piezo. | Experimental | After flap reflection bone and root end cutting are done with US6 piezoelectric surgical insert Receives: Procedure: piezoelectric surgery |
| Periapical surgery with bur. | Active comparator | After flap reflection bone and root end cutting are done with surgical bur. Receives: Procedure: conventional bur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life assessment
By quality of life questionnaire(Igor Tsesis et al)
Measured: 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
Measured: 12 months
Secondary outcomes (1)
hemorrhage control
assessed by scores used by Vy et al
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Dec 2018
- Primary completion30 Apr 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical DiseaseStudies 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
- Double blind
- Who is masked
- Participant, 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
- Sponsor
- Investigators
- JAYA BHARATHI, Principal investigator, POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358887
- Sponsor's protocol ID
- Dr.Jaya Bharathi
- Status last verified
- Apr 2020
- First submitted
- 21 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Piezoelectric Surgery on Quality of Life and Periradicular Healing After Endodontic Surgery : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04358887
- Acronym / sponsor ID
- Dr.Jaya Bharathi
- Conditions
- Periapical Disease
- Keywords
- piezoelectric surgery, quality of life, hemostasis
- 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 Dec 2018 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 24 Apr 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| periapical surgery with piezo. | Experimental | Procedure: piezoelectric surgeryAfter flap reflection bone and root end cutting are done with US6 piezoelectric surgical insert |
| Periapical surgery with bur. | Active comparator | Procedure: conventional burAfter flap reflection bone and root end cutting are done with surgical bur. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- Unrestorable tooth.
- Fractured / perforated tooth.
- Apicomarginal defects.
- Through \& through lesions.
- Teeth with deep pockets.
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 |
|---|---|---|
| piezoelectric surgeryafter flap reflection bone and root end cutting are done with piezoelectric surgical insert | Procedure or surgery | periapical surgery with piezo. |
| conventional burafter flap reflection bone and root end cutting are done with surgical bur | Procedure or surgery | Periapical surgery with bur. |
Primary outcome
Quality of life assessment
Time frame: Till 1 week after surgery
By quality of life questionnaire(Igor Tsesis et al)
Postoperative healing
Time frame: 12 months
2D radiographic healing by Rud et al and Molven et al criteria and 3D healing by modified PENN 3D criteria
1 secondary outcome
hemorrhage control
Time frame: during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: No
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Early Healing of Apical Periodontitis After Root Canal Treatment With Bioceramic and Calcium Hydroxide Medicaments: Evaluation Using PAI and ImageJ
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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.
JAYA BHARATHI principal investigator
POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing piezoelectric surgery and conventional bur in people with Periapical Disease, 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 7 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 24 Apr 2020. 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 1 week 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 24 Apr 2020.