Periapical; InfectionNCT06031792
Radiographic Assessment of the Healing Pattern Associated With Periradicular Endodontic Microsurgery
A study testing Piezo endodontic surgery and Conventional endodontic surgery in people with Periapical; Infection, run by King Abdullah University Hospital at 2 sites in Jordan.
Trial summary
Endodontic periradicular microsurgery is a dental procedure to treat apical periodontitis in cases in which healing has not occurred after non-surgical treatment or if it is not feasible. Recent advances in techniques and materials have resulted in more predictable outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical; Infection
- What is being tested?
- Piezo endodontic surgery and Conventional endodontic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesJordan
- Study dates
- 30 Sep 2021to 30 Sep 2026
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medically fit patients
- Age (18-65 )
- Teeth that are periodontally healthy
- Coronally sealed root canal treated teeth
Who cannot join
- Patients with an active systematic disease that may affect the short- and long-term outcomes or restrict surgical intervention
- Emotionally distressed patients
- Patients who had received analgesics or antibiotics prior to surgery will be postponed
- Cases where orthograde endodontic treatment is feasible, will be retreated at the post-graduate clinics and not included in this study
- Teeth with poor prognosis (e.g., non-restorable, vertical root fracture, short roots, non-strategic tooth, endo-perio lesion
Trial locations and contacts
2 sites in 1 country.
Jordan2 sites, 2 recruiting
- Recruiting
Jordan University of Science and Technology
Irbid, POBOX 3030
Lama A Awawdeh, PhD, 0795412954, lawawdeh@hotmail.com
- Recruiting
Jordan University of Science and Technology
Irbid, POBOX 3030
Lama A Awawdeh, PhD, +962795412954, lawawdeh@hotmail.com
About this study
Official title: A 2D and 3D Radiographic Assessment of the Healing Pattern Associated With Conventional and Piezoelectric Periradicular Endodontic Microsurgery
Endodontic periradicular microsurgery is a dental procedure to treat apical periodontitis in cases in which healing has not occurred after non-surgical treatment or if it is not feasible. Recent advances in techniques and materials have resulted in more predictable outcomes. Piezotome is a new and innovative device, but limited evidence is available regarding its use in endodontics. The aim of this study is to assess the healing pattern of conventional periradicular microsurgery and piezoelectric periradicular microsurgery in 2- Dimensional and 3-Dimensional imaging, and further to perform histological analysis for the presence, location, and arrangement of bacteria in the excised apical portion of the root canal system.
Read the detailed description
After meeting the inclusion criteria, a total of 44 Patients in need of endodontic microsurgery with persistent symptoms after acceptable primary root canal treatment or failed retreatment with persistent symptoms/periapical lesions will be included in this study. Participants will be randomly allocated to group one; conventional periradicular surgery or group two; piezoelectric periradicular microsurgery. A preoperative digital periapical and limited view cone beam computed tomography (CBCT) radiographs will be taken for each patient. At 12-18 months recall visit a second digital periapical radiograph and limited view CBCT will be taken. All images will be evaluated on high-definition LCD display with installed ImageJ software and CBCT software, and window settings will be fixed for all cases. Radiographs will be evaluated by two calibrated dentists. The excised root tip with their surrounding tissues will be fixed immediately after harvesting for 24 hours at 4 °C by immersion in 1% glutaraldehyde and 1% formaldehyde and referred to histopathologic laboratory. Fixed specimens will be demineralized in 10% formic acid and processed. Serial sectioning with hematoxylin and eosin staining will be done to locate the areas with the most severe reactions. In addition, the Taylor modification of the Brown-Brenn staining will be used to detect the presence of bacteria.
- Conditions
- Periapical; Infection
- Being tested
- Piezo endodontic surgery, Conventional endodontic surgery
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezo endodontic surgeryProcedure or surgery
Osteotomy will be done with Piezosurgery touch. After the soft tissue curettage and uncovering the root apex, the last 3 mm of the root apex will be resected perpendicular to the long axis of the tooth using piezotome. apical preparation will be performed and Biodentine®retrograde filling material will be placed. The flap will be re-approximated and interrupted suture using non-absorbable monofilament suture will be applied. Finally, Post-operative parallel Digital view.
Conventional endodontic surgeryProcedure or surgery
After the soft tissue curettage and exposure of the root apex, the osteotomy will be performed using a conventional surgical handpiece. The same steps will be followed to prepare and restore the root, as well as to reposition the flap.
| Study group | Role | What they receive |
|---|---|---|
| Piezo endodontic surgery | Experimental | Experimental: Piezo endodontic surgery The osteotomy will be applied under magnification with a surgical operating microscope (at the apical third of the root. Osteotomy will be done with the Piezosurgery touch Receives: Procedure: Piezo endodontic surgery |
| Conventional endodontic surgery | Experimental | Experimental: Conventional endodontic surgery The osteotomy will be applied under magnification with a surgical operating microscope at the apical third of the root. Osteotomy will be done with air motor high speed hand-piece and round bur with copious irrigation Receives: Procedure: Conventional endodontic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Healing
To compare conventional and piezotome endodontic apical surgery in terms of healing using 2-Dimensional and 3-Dimensional imaging CBCT.
Measured: to measure periapical lesion through study completion, an average of 1 year
Histological outcome
To correlate histological findings with clinical observation and radiographic findings for failed root canal treated teeth presenting
Measured: one sample is taken and compared immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start30 Sep 2021
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical; InfectionStudies of the same condition, open and under way.
- 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
- Model description
- A randomized prospective clinical study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031792
- Sponsor's protocol ID
- KingAbdullahUH1
- Status last verified
- Jun 2024
- First submitted
- 4 Sep 2023
- Last updated
- 17 Jun 2024
- Results posted
- No
- 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 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2D and 3D Radiographic Assessment of the Healing Pattern Associated With Conventional and Piezoelectric Periradicular Endodontic Microsurgery
- ClinicalTrials.gov ID
- NCT06031792
- Acronym / sponsor ID
- KingAbdullahUH1
- Conditions
- Periapical; Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 11 Sep 2023 (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.
Endodontic periradicular microsurgery is a dental procedure to treat apical periodontitis in cases in which healing has not occurred after non-surgical treatment or if it is not feasible. Recent advances in techniques and materials have resulted in more predictable outcomes. Piezotome is a new and innovative device, but limited evidence is available regarding its use in endodontics. The aim of this study is to assess the healing pattern of conventional periradicular microsurgery and piezoelectric periradicular microsurgery in 2- Dimensional and 3-Dimensional imaging, and further to perform histological analysis for the presence, location, and arrangement of bacteria in the excised apical portion of the root canal system.
Detailed description
After meeting the inclusion criteria, a total of 44 Patients in need of endodontic microsurgery with persistent symptoms after acceptable primary root canal treatment or failed retreatment with persistent symptoms/periapical lesions will be included in this study. Participants will be randomly allocated to group one; conventional periradicular surgery or group two; piezoelectric periradicular microsurgery. A preoperative digital periapical and limited view cone beam computed tomography (CBCT) radiographs will be taken for each patient. At 12-18 months recall visit a second digital periapical radiograph and limited view CBCT will be taken. All images will be evaluated on high-definition LCD display with installed ImageJ software and CBCT software, and window settings will be fixed for all cases. Radiographs will be evaluated by two calibrated dentists. The excised root tip with their surrounding tissues will be fixed immediately after harvesting for 24 hours at 4 °C by immersion in 1% glutaraldehyde and 1% formaldehyde and referred to histopathologic laboratory. Fixed specimens will be demineralized in 10% formic acid and processed. Serial sectioning with hematoxylin and eosin staining will be done to locate the areas with the most severe reactions. In addition, the Taylor modification of the Brown-Brenn staining will be used to detect the presence of bacteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized prospective clinical study
| Arm | Type | Receives |
|---|---|---|
| Piezo endodontic surgery | Experimental | Procedure: Piezo endodontic surgeryExperimental: Piezo endodontic surgery The osteotomy will be applied under magnification with a surgical operating microscope (at the apical third of the root. Osteotomy will be done with the Piezosurgery touch |
| Conventional endodontic surgery | Experimental | Procedure: Conventional endodontic surgeryExperimental: Conventional endodontic surgery The osteotomy will be applied under magnification with a surgical operating microscope at the apical third of the root. Osteotomy will be done with air motor high speed hand-piece and round bur with copious irrigation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Medically fit patients
- Age (18-65 )
- Teeth that are periodontally healthy
- Coronally sealed root canal treated teeth
Key exclusion criteria (5 listed)
- Patients with an active systematic disease that may affect the short- and long-term outcomes or restrict surgical intervention
- Emotionally distressed patients
- Patients who had received analgesics or antibiotics prior to surgery will be postponed
- Cases where orthograde endodontic treatment is feasible, will be retreated at the post-graduate clinics and not included in this study
- Teeth with poor prognosis (e.g., non-restorable, vertical root fracture, short roots, non-strategic tooth, endo-perio lesion
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 |
|---|---|---|
| Piezo endodontic surgeryOsteotomy will be done with Piezosurgery touch. After the soft tissue curettage and uncovering the root apex, the last 3 mm of the root apex will be resected perpendicular to the long axis of the tooth using piezotome. apical preparation will be performed and Biodentine®retrograde filling material will be placed. The flap will be re-approximated and interrupted suture using non-absorbable monofilament suture will be applied. Finally, Post-operative parallel Digital view. | Procedure or surgery | Piezo endodontic surgery |
| Conventional endodontic surgeryAfter the soft tissue curettage and exposure of the root apex, the osteotomy will be performed using a conventional surgical handpiece. The same steps will be followed to prepare and restore the root, as well as to reposition the flap. | Procedure or surgery | Conventional endodontic surgery |
Primary outcome
Radiographic Healing
Time frame: to measure periapical lesion through study completion, an average of 1 year
To compare conventional and piezotome endodontic apical surgery in terms of healing using 2-Dimensional and 3-Dimensional imaging CBCT.
Histological outcome
Time frame: one sample is taken and compared immediately after surgery
To correlate histological findings with clinical observation and radiographic findings for failed root canal treated teeth presenting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezo endodontic surgery and Conventional endodontic surgery in people with Periapical; Infection, run by King Abdullah University Hospital at 2 sites in Jordan.
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 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Jordan. 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 Lama A Awawdeh, PhD (+962795412954, lawawdeh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Healing (time frame: to measure periapical lesion through study completion, an average of 1 year). 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 17 Jun 2024.