Periapical PeriodontitisBURVSPIEZONCT07197658
Healing After Endodontic Microsurgery Using a Rotary Bur Versus Piezoelectric Unit for Osteotomy and Root Resection
A study testing endodontic microsurgery / rotary bur osteotomy, Endodontic microsurgery / piezo osteotomy and Endodontic microsurgery / bone window in people with Periapical Periodontitis and Endodontic Microsurgery, run by National and Kapodistrian University of Athens at 2 sites in Greece.
Trial summary
The goal of this clinical trial is to compare bone healing after using apical tooth microsurgery to remove root end infection, either by use of rotary burs for cutting bone and root end, or by use of piezoelectric surgery for the same procedures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periapical Periodontitis, Endodontic Microsurgery, Osteotomy
- What is being tested?
- endodontic microsurgery / rotary bur osteotomy, Endodontic microsurgery / piezo osteotomy and Endodontic microsurgery / bone window
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesGreece
- Study dates
- 25 Apr 2023to 10 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years and older consenting to the surgical procedure as well as agreeing to preoperative, postoperative and at least one follow-up CBCT evaluation after 12 months
- Noncontributory medical history (American Society of Anesthesiologists class I and II)
- A history of previous endodontic treatment with radiographic presence of apical periodontitis
- A true endodontic lesion: microsurgical classification A, B, or C according to Kim and Kratchman, 2006.
- Lesion size 10 mm or smaller in diameter measured on preoperative CBCT
- Coronal restoration should be present at the time of follow up examination.
Who cannot join
- Nonconsenting patients and patients younger than 18 years of age
- Medical history with American Society of Anesthesiologists class III to V
- Insufficient coronal restoration
- Nonrestorability or traumatized teeth
- Teeth with microsurgical classification D, E, or F according to Kim and Kratchman, 2006.
- Mobility I or higher
Show all 10Show fewer
- Radiographic presence of nonapical root resorption
- Teeth with a vertical root fracture or coronal/ midroot perforation
- Lesion size larger than 10 mm in diameter measured on preoperative CBCT
- Use of bone graft material for regeneration
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Private Dental Office
Athens, Attica, 11528
Spyros Floratos Private Dental Office
Athens, Attica, 11528
About this study
Official title: Prospective Healing Assessment After Application of Endodontic Microsurgery for Elimination of Apical Pathology By Use of Either a Rotary Bur for Osteotomy and Apical Root Resection, or Piezoelectric Unit for the Same Clinical Procedures
The goal of this clinical trial is to compare bone healing after using apical tooth microsurgery to remove root end infection, either by use of rotary burs for cutting bone and root end, or by use of piezoelectric surgery for the same procedures.
The main questions it aims to answer are:
- Is there a difference in bone healing and reformation between the two surgical procedures ?
- Is there a difference in bone healing between cutting the bone with a rotary bur and cutting the bone with the 'bone window' technique that uses piezoelectric unit ?
Read the detailed description
The aim of this study is to prospectively compare postsurgical healing after the use of microsurgical technique to eliminate apical pathology, either by use of rotary burs for osteotomy and root resection, or by use of piezoelectric surgery for the same clinical procedures. Null hypothesis is that there is no difference in healing and buccal bone thickness reformation between the two surgical procedures Another purpose of the study is to prospectively evaluate healing after the application of a novel buccal bone preservation technique, called the 'bone window' technique. The technique will be applied in a subgroup of patients on maxillary and mandibular premolar and molar teeth with an intact buccal cortical bone and healing and buccal bone reformation will be assessed at follow up. Null hypothesis in this part, is that there is no difference in healing and buccal bone preservation between osteotomy with a bur and the 'bone window' technique.
- Conditions
- Periapical Periodontitis, Endodontic Microsurgery, Osteotomy
- Being tested
- endodontic microsurgery / rotary bur osteotomy, Endodontic microsurgery / piezo osteotomy, Endodontic microsurgery / bone window
- Keywords
- Endodontic surgery, Piezosurgery, Bone window
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endodontic microsurgery / rotary bur osteotomyProcedure or surgery
Also called bur osteotomy, endodontic microsurgery
Endodontic microsurgery will be executed by use of a rotary bur
Endodontic microsurgery / piezo osteotomyProcedure or surgery
Also called endodontic surgery, surgical endodontic retreatment, piezosurgery
Endodontic microsurgery will be performed by use of a piezosurgery unit
Endodontic microsurgery / bone windowProcedure or surgery
Also called apical surgery, bone lid
'Bone window' technique will be performed by use of piezoelectric surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Experimental Group) - Rotary bur | Experimental | Endodontic microsurgery will be performed by use of a rotary bur Receives: Procedure: endodontic microsurgery / rotary bur osteotomy |
| Group 2 (Control Group) - Piezoelectric unit | Active comparator | Endodontic microsurgery will be performed by use of a piezoelectric unit Receives: Procedure: Endodontic microsurgery / piezo osteotomy |
| Bone Window subgroup | Active comparator | 'Bone window' technique will be performed Receives: Procedure: Endodontic microsurgery / bone window |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two dimensional radiographic bone healing
Bone healing will be measured on periapical radiograph using well established two dimensional criteria for bone healing assessment. Molven's criteria categorize healing using periapical films into four categories: complete healing, incomplete healing, uncertain and unsatisfactory healing
Measured: From execution of the microsurgical procedure to one year or later follow up examination
Three dimensional radiographic bone healing
Bone healing will be measured on Cone Beam Computed Tomography (CBCT) scan using well established three dimensional criteria for bone healing assessment. Penn 3D criteria categorize healing using CBCT scans into three categories: complete healing, limited and unsatisfactory healing
Measured: From execution of the microsurgical procedure to one year or later follow up examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start25 Apr 2023
- Primary completion11 May 2026
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Periapical PeriodontitisStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For this prospective investigation, patients will be randomly allocated into two groups. In the experimental group, endodontic microsurgery will be performed by use of a rotary bur for osteotomy and apical root resection. In the control group, piezoelectric surgery will be used for the same clinical procedures. All surgical procedures will be performed by one operator. Postsurgical healing as well as certain preoperative and postoperative parameters will be assessed and compared in the two groups. In a subgroup of patients having at least 2mm of intact buccal cortical bone thickness preoperatively, piezoelectric surgery will be used to prepare a rectangular buccal 'bone window'. The buccal bone thickness will be measured preoperatively on the coronal slices of the Cone Beam Computed Tomography (CBCT). After completing the root end filling, the bone window will be repositioned at the original position
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Spyros Floratos, National and Kapodistrian University of Athens
- Investigators
- Apostolos Tsolakis, DMD,MS,PhD, Study director, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197658
- Sponsor's protocol ID
- 129586
- Acronym
- BURVSPIEZO
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication
Publications
von Arx T, Janner SF, Hanni S, Bornstein MM. Agreement between 2D and 3D radiographic outcome assessment one year after periapical surgery. Int Endod J. 2016 Oct;49(10):915-25. doi: 10.1111/iej.12548. Epub 2015 Oct 8.
PubMed 26356580Chen I, Karabucak B, Wang C, Wang HG, Koyama E, Kohli MR, Nah HD, Kim S. Healing after root-end microsurgery by using mineral trioxide aggregate and a new calcium silicate-based bioceramic material as root-end filling materials in dogs. J Endod. 2015 Mar;41(3):389-99. doi: 10.1016/j.joen.2014.11.005. Epub 2015 Jan 14.
PubMed 25596728Hirsch V, Kohli MR, Kim S. Apicoectomy of maxillary anterior teeth through a piezoelectric bony-window osteotomy: two case reports introducing a new technique to preserve cortical bone. Restor Dent Endod. 2016 Nov;41(4):310-315. doi: 10.5395/rde.2016.41.4.310. Epub 2016 Jul 5.
PubMed 27847753Khoury F, Hensher R. The bony lid approach for the apical root resection of lower molars. Int J Oral Maxillofac Surg. 1987 Apr;16(2):166-70. doi: 10.1016/s0901-5027(87)80125-x.
PubMed 3110314Vercellotti T, De Paoli S, Nevins M. The piezoelectric bony window osteotomy and sinus membrane elevation: introduction of a new technique for simplification of the sinus augmentation procedure. Int J Periodontics Restorative Dent. 2001 Dec;21(6):561-7.
PubMed 11794567Yaman Z, Suer BT. Piezoelectric surgery in oral and maxillofacial surgery. Annals of Oral and Maxillofacial Surgery. 2013; 1:1-9
Chopra P, Chopra P. Piezosurgery and its applications in Periodontology and Implantology. International Journal of Contemporary Dentistry. 2011;2(4): 16-24
Rashad A, Kaiser A, Prochnow N, Schmitz I, Hoffmann E, Maurer P. Heat production during different ultrasonic and conventional osteotomy preparations for dental implants. Clin Oral Implants Res. 2011 Dec;22(12):1361-5. doi: 10.1111/j.1600-0501.2010.02126.x. Epub 2011 Mar 21.
PubMed 21435005Song M, Kim E. A prospective randomized controlled study of mineral trioxide aggregate and super ethoxy-benzoic acid as root-end filling materials in endodontic microsurgery. J Endod. 2012 Jul;38(7):875-9. doi: 10.1016/j.joen.2012.04.008. Epub 2012 May 16.
PubMed 22703646Tsesis I, Rosen E, Schwartz-Arad D, Fuss Z. Retrospective evaluation of surgical endodontic treatment: traditional versus modern technique. J Endod. 2006 May;32(5):412-6. doi: 10.1016/j.joen.2005.10.051.
PubMed 16631838Setzer FC, Shah SB, Kohli MR, Karabucak B, Kim S. Outcome of endodontic surgery: a meta-analysis of the literature--part 1: Comparison of traditional root-end surgery and endodontic microsurgery. J Endod. 2010 Nov;36(11):1757-65. doi: 10.1016/j.joen.2010.08.007. Epub 2010 Sep 17.
PubMed 20951283Safi C, Kohli MR, Kratchman SI, Setzer FC, Karabucak B. Outcome of Endodontic Microsurgery Using Mineral Trioxide Aggregate or Root Repair Material as Root-end Filling Material: A Randomized Controlled Trial with Cone-beam Computed Tomographic Evaluation. J Endod. 2019 Jul;45(7):831-839. doi: 10.1016/j.joen.2019.03.014. Epub 2019 May 9.
PubMed 31078325Floratos S, Kim S. Modern Endodontic Microsurgery Concepts: A Clinical Update. Dent Clin North Am. 2017 Jan;61(1):81-91. doi: 10.1016/j.cden.2016.08.007.
PubMed 27912820Kim S, Kratchman S. Modern endodontic surgery concepts and practice: a review. J Endod. 2006 Jul;32(7):601-23. doi: 10.1016/j.joen.2005.12.010. Epub 2006 May 6.
PubMed 16793466
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Healing Assessment After Application of Endodontic Microsurgery for Elimination of Apical Pathology By Use of Either a Rotary Bur for Osteotomy and Apical Root Resection, or Piezoelectric Unit for the Same Clinical Procedures
- ClinicalTrials.gov ID
- NCT07197658
- Acronym / sponsor ID
- BURVSPIEZO / 129586
- Conditions
- Periapical Periodontitis, Endodontic Microsurgery, Osteotomy
- Keywords
- Endodontic surgery, Piezosurgery, Bone window
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 124 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 29 Sep 2025 (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 goal of this clinical trial is to compare bone healing after using apical tooth microsurgery to remove root end infection, either by use of rotary burs for cutting bone and root end, or by use of piezoelectric surgery for the same procedures.
The main questions it aims to answer are:
- Is there a difference in bone healing and reformation between the two surgical procedures ?
- Is there a difference in bone healing between cutting the bone with a rotary bur and cutting the bone with the 'bone window' technique that uses piezoelectric unit ?
Detailed description
The aim of this study is to prospectively compare postsurgical healing after the use of microsurgical technique to eliminate apical pathology, either by use of rotary burs for osteotomy and root resection, or by use of piezoelectric surgery for the same clinical procedures. Null hypothesis is that there is no difference in healing and buccal bone thickness reformation between the two surgical procedures Another purpose of the study is to prospectively evaluate healing after the application of a novel buccal bone preservation technique, called the 'bone window' technique. The technique will be applied in a subgroup of patients on maxillary and mandibular premolar and molar teeth with an intact buccal cortical bone and healing and buccal bone reformation will be assessed at follow up. Null hypothesis in this part, is that there is no difference in healing and buccal bone preservation between osteotomy with a bur and the 'bone window' technique.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- For this prospective investigation, patients will be randomly allocated into two groups. In the experimental group, endodontic microsurgery will be performed by use of a rotary bur for osteotomy and apical root resection. In the control group, piezoelectric surgery will be used for the same clinical procedures. All surgical procedures will be performed by one operator. Postsurgical healing as well as certain preoperative and postoperative parameters will be assessed and compared in the two groups. In a subgroup of patients having at least 2mm of intact buccal cortical bone thickness preoperatively, piezoelectric surgery will be used to prepare a rectangular buccal 'bone window'. The buccal bone thickness will be measured preoperatively on the coronal slices of the Cone Beam Computed Tomography (CBCT). After completing the root end filling, the bone window will be repositioned at the original position
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Experimental Group) - Rotary bur | Experimental | Procedure: endodontic microsurgery / rotary bur osteotomyEndodontic microsurgery will be performed by use of a rotary bur |
| Group 2 (Control Group) - Piezoelectric unit | Active comparator | Procedure: Endodontic microsurgery / piezo osteotomyEndodontic microsurgery will be performed by use of a piezoelectric unit |
| Bone Window subgroup | Active comparator | Procedure: Endodontic microsurgery / bone window'Bone window' technique will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years and older consenting to the surgical procedure as well as agreeing to preoperative, postoperative and at least one follow-up CBCT evaluation after 12 months
- Noncontributory medical history (American Society of Anesthesiologists class I and II)
- A history of previous endodontic treatment with radiographic presence of apical periodontitis
- A true endodontic lesion: microsurgical classification A, B, or C according to Kim and Kratchman, 2006.
- Lesion size 10 mm or smaller in diameter measured on preoperative CBCT
Key exclusion criteria (10 listed)
- Nonconsenting patients and patients younger than 18 years of age
- Medical history with American Society of Anesthesiologists class III to V
- Insufficient coronal restoration
- Nonrestorability or traumatized teeth
- Teeth with microsurgical classification D, E, or F according to Kim and Kratchman, 2006.
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 |
|---|---|---|
| endodontic microsurgery / rotary bur osteotomyAlso: bur osteotomy, endodontic microsurgeryEndodontic microsurgery will be executed by use of a rotary bur | Procedure or surgery | Group 1 (Experimental Group) - Rotary bur |
| Endodontic microsurgery / piezo osteotomyAlso: endodontic surgery, surgical endodontic retreatment, piezosurgeryEndodontic microsurgery will be performed by use of a piezosurgery unit | Procedure or surgery | Group 2 (Control Group) - Piezoelectric unit |
| Endodontic microsurgery / bone windowAlso: apical surgery, bone lid'Bone window' technique will be performed by use of piezoelectric surgery | Procedure or surgery | Bone Window subgroup |
Primary outcome
Two dimensional radiographic bone healing
Time frame: From execution of the microsurgical procedure to one year or later follow up examination
Bone healing will be measured on periapical radiograph using well established two dimensional criteria for bone healing assessment. Molven's criteria categorize healing using periapical films into four categories: complete healing, incomplete healing, uncertain and unsatisfactory healing
Three dimensional radiographic bone healing
Time frame: From execution of the microsurgical procedure to one year or later follow up examination
Bone healing will be measured on Cone Beam Computed Tomography (CBCT) scan using well established three dimensional criteria for bone healing assessment. Penn 3D criteria categorize healing using CBCT scans into three categories: complete healing, limited and unsatisfactory healing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 26356580von Arx T, Janner SF, Hanni S, Bornstein MM. Agreement between 2D and 3D radiographic outcome assessment one year after periapical surgery. Int Endod J. 2016 Oct;49(10):915-25. doi: 10.1111/iej.12548. Epub 2015 Oct 8.
- Background: PubMed 25596728Chen I, Karabucak B, Wang C, Wang HG, Koyama E, Kohli MR, Nah HD, Kim S. Healing after root-end microsurgery by using mineral trioxide aggregate and a new calcium silicate-based bioceramic material as root-end filling materials in dogs. J Endod. 2015 Mar;41(3):389-99. doi: 10.1016/j.joen.2014.11.005. Epub 2015 Jan 14.
- Background: PubMed 27847753Hirsch V, Kohli MR, Kim S. Apicoectomy of maxillary anterior teeth through a piezoelectric bony-window osteotomy: two case reports introducing a new technique to preserve cortical bone. Restor Dent Endod. 2016 Nov;41(4):310-315. doi: 10.5395/rde.2016.41.4.310. Epub 2016 Jul 5.
- Background: PubMed 3110314Khoury F, Hensher R. The bony lid approach for the apical root resection of lower molars. Int J Oral Maxillofac Surg. 1987 Apr;16(2):166-70. doi: 10.1016/s0901-5027(87)80125-x.
- Background: PubMed 11794567Vercellotti T, De Paoli S, Nevins M. The piezoelectric bony window osteotomy and sinus membrane elevation: introduction of a new technique for simplification of the sinus augmentation procedure. Int J Periodontics Restorative Dent. 2001 Dec;21(6):561-7.
- BackgroundYaman Z, Suer BT. Piezoelectric surgery in oral and maxillofacial surgery. Annals of Oral and Maxillofacial Surgery. 2013; 1:1-9
- BackgroundChopra P, Chopra P. Piezosurgery and its applications in Periodontology and Implantology. International Journal of Contemporary Dentistry. 2011;2(4): 16-24
- Background: PubMed 21435005Rashad A, Kaiser A, Prochnow N, Schmitz I, Hoffmann E, Maurer P. Heat production during different ultrasonic and conventional osteotomy preparations for dental implants. Clin Oral Implants Res. 2011 Dec;22(12):1361-5. doi: 10.1111/j.1600-0501.2010.02126.x. Epub 2011 Mar 21.
- Background: PubMed 22703646Song M, Kim E. A prospective randomized controlled study of mineral trioxide aggregate and super ethoxy-benzoic acid as root-end filling materials in endodontic microsurgery. J Endod. 2012 Jul;38(7):875-9. doi: 10.1016/j.joen.2012.04.008. Epub 2012 May 16.
- Background: PubMed 16631838Tsesis I, Rosen E, Schwartz-Arad D, Fuss Z. Retrospective evaluation of surgical endodontic treatment: traditional versus modern technique. J Endod. 2006 May;32(5):412-6. doi: 10.1016/j.joen.2005.10.051.
- Background: PubMed 20951283Setzer FC, Shah SB, Kohli MR, Karabucak B, Kim S. Outcome of endodontic surgery: a meta-analysis of the literature--part 1: Comparison of traditional root-end surgery and endodontic microsurgery. J Endod. 2010 Nov;36(11):1757-65. doi: 10.1016/j.joen.2010.08.007. Epub 2010 Sep 17.
- Background: PubMed 31078325Safi C, Kohli MR, Kratchman SI, Setzer FC, Karabucak B. Outcome of Endodontic Microsurgery Using Mineral Trioxide Aggregate or Root Repair Material as Root-end Filling Material: A Randomized Controlled Trial with Cone-beam Computed Tomographic Evaluation. J Endod. 2019 Jul;45(7):831-839. doi: 10.1016/j.joen.2019.03.014. Epub 2019 May 9.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication
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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.
Apostolos Tsolakis, DMD,MS,PhD study director
National and Kapodistrian University of Athens
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endodontic microsurgery / rotary bur osteotomy, Endodontic microsurgery / piezo osteotomy and Endodontic microsurgery / bone window in people with Periapical Periodontitis and Endodontic Microsurgery, run by National and Kapodistrian University of Athens at 2 sites in Greece.
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 10 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. 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 Greece. 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?
This study is still under way. Results are not available in the source record yet.
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?
Two dimensional radiographic bone healing (time frame: From execution of the microsurgical procedure to one year or later follow up examination). 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?
On the ClinicalTrials.gov record for NCT07197658, which also lists 14 linked publications.
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 16 Sep 2026.