Endodontic DiseaseNCT05283252
The 3-Dimensional Printed Guide in Endodontic Microsurgery
A study testing 3-D printed Guide and Conventional Endodontic Micro-Surgery in people with Endodontic Disease and Endodontic Re-treatment Failure, run by Damascus University at 1 site in Syria.
Trial summary
In recent years, there was a great interest in employing the surgical guide in dentistry due to the development occurred in the 3D printing which became available widely. Cone beam computed tomography (CBCT) is necessary and crucial in planning for endodontic surgery, but the procedure still depends on how the surgeon… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Disease, Endodontic Re-treatment Failure
- What is being tested?
- 3-D printed Guide and Conventional Endodontic Micro-Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSyria
- Study dates
- 15 Apr 2022to 15 Jun 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients in good general health.
- Patients with age ranging between 18-50 years.
- Posterior/anterior teeth close to critical anatomical structures that indicated for endodontic surgery.
- Patients' acceptance to participate in the trail.
Who cannot join
- Patients with allergy to materials or medications used in the trial.
- Patients with Serious systemic disease incompatible with surgery.
- Pregnant female patients.
- Teeth with periapical pathosis associated with vertical root fracture.
- Non-restorable teeth.
- Teeth with periodontal probe more than 5 mm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of Guided Endodontic Microsurgery in Critical Anatomical Structures (A Randomized Clinical Trial)
In recent years, there was a great interest in employing the surgical guide in dentistry due to the development occurred in the 3D printing which became available widely.
Cone beam computed tomography (CBCT) is necessary and crucial in planning for endodontic surgery, but the procedure still depends on how the surgeon reflect the 3D images on the anatomical structures accurately, which may leave room for error.
This study is to compare the clinical and radiographic outcomes using guided endodontic microsurgery versus conventional endodontic microsurgery in critical anatomical structures.
Read the detailed description
Endodontic microsurgery in critical anatomical structures is considered as a serious challenge for the endodontist.
Major advances have been made to the techniques used in endodontic surgery to make the procedure easier to perform, safer and more predictable.
Several case reports that used surgical guide in endodontic microsurgery found that the procedure was more accurate in control of depth, diameter and angle of osteotomy.
The aim of this study is to compare the clinical and radiographic outcomes using guided endodontic microsurgery versus conventional endodontic microsurgery in critical anatomical structures.
Patients will be selected that they are indicated for endodontic surgery. Upper and lower teeth will be selected close to critical anatomy such as; maxillary sinus, nasal fossa, mental foramen and mandibular canal. medical and dental history will be obtained from all selected patients. Patients will be randomly distributed to either guided micro-surgery group or conventional micro-surgery group. All steps of the surgical procedure will be performed under microscopic magnification. Bioceramic putty will be used as a root-end filling material. Post-surgical instructions will be given to patients. The time of the surgery will be recorded from the first incision to the last suturing. Success and failure will be assessed using radiographic and clinical evaluation at 6 and 12 months.
- Being tested
- 3-D printed Guide, Conventional Endodontic Micro-Surgery
- Keywords
- Apicoectomy, Guided Endodontic Surgery, Micro-Surgery, Surgical Guide, 3-Dimensional Printed, Critical Structures
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-D printed GuideDevice
Guided Endodontic micro-surgery
Conventional Endodontic Micro-SurgeryOther
Free-hand endodontic micro-surgery
| Study group | Role | What they receive |
|---|---|---|
| Guided Endodontic Micro-Surgery | Experimental | Use of the 3-D printed guide in endodontic micro-surgery Receives: Device: 3-D printed Guide |
| Conventional Endodontic Micro-Surgery | Placebo comparator | Free-hand endodontic micro-surgery Receives: Other: Conventional Endodontic Micro-Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success at two weeks
The position of the oral mucosa at the flap site will be assessed after surgery to evaluate wound healing using the wound healing index (WHI) by Huang et al 2005 as the following criteria:
Score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence.
Score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration.
Score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration.
Measured: Periodontal tissue healing will be evaluated clinically "2 weeks"
Clinical Success at one year
The patient's symptoms will be evaluated and the examination will be done on percussion, palpation and probing. Clinical Success will be defined as absence of pain, swelling or sensitivity on percussion. Clinical failure is the persistence of any of the above-mentioned symptoms.
Measured: Clinical signs or symptoms will be evaluated "1 year"
Radiographic Success at 6 months
Early follow-up will be done and the initial radiographic Success or failure will be assessed.
The size of periapical lesions/radiographic transparency will be measured in millimeters by periapical radiographs and CBCT images
Measured: Periapical tissues healing will be evaluated radiographically at 6 months after surgery
Radiographic Success at 12 months
Radiographic Success will be defined as either complete or incomplete healing (formation of scar tissue). Radiographic Failure will involve either uncertain healing (small or constant lesion size) or unsatisfactory healing (increased lesion size).
The size of periapical lesions/radiographic transparency will be measured in millimeters by periapical radiographs and CBCT images
Measured: Periapical tissues healing will be evaluated radiographically at 12 months after surgery
Secondary outcomes (2)
Time of surgery
The surgical time will be recorded in minutes from the first incision to the last suturing
Measured: During surgery
Change in Pain Perception
Pain assessment will be performed using a Visual Analog Scale (VAS) which is a subjective measure instrument for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 (no pain) and 10 (worst pain).
Measured: Pain will be evaluated at 24, 48, and 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start15 Apr 2022
- Primary completion15 Jun 2022
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Endodontic DiseaseStudies 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
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rami Kaddoura, DDS,MSc, Principal investigator, Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283252
- Sponsor's protocol ID
- UDDS-Endo-01-2022
- Status last verified
- Sep 2023
- First submitted
- 27 Feb 2022
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Buniag AG, Pratt AM, Ray JJ. Targeted Endodontic Microsurgery: A Retrospective Outcomes Assessment of 24 Cases. J Endod. 2021 May;47(5):762-769. doi: 10.1016/j.joen.2021.01.007. Epub 2021 Feb 4.
PubMed 33548331Lio F, Mampieri G, Mazzetti V, Leggeri A, Arcuri L. Guided endodontic microsurgery in apicoectomy: a review. J Biol Regul Homeost Agents. 2021 May-Jun;35(3 Suppl. 1):47-55. doi: 10.23812/21-3supp1-7.
PubMed 34289664Popowicz W, Palatynska-Ulatowska A, Kohli MR. Targeted Endodontic Microsurgery: Computed Tomography-based Guided Stent Approach with Platelet-rich Fibrin Graft: A Report of 2 Cases. J Endod. 2019 Dec;45(12):1535-1542. doi: 10.1016/j.joen.2019.08.012. Epub 2019 Oct 9.
PubMed 31606146Monaghan L, Jadun S, Darcey J. Endodontic microsurgery. Part one: diagnosis, patient selection and prognoses. Br Dent J. 2019 Jun;226(12):940-948. doi: 10.1038/s41415-019-0415-3.
PubMed 31253911Antal M, Nagy E, Braunitzer G, Frater M, Piffko J. Accuracy and clinical safety of guided root end resection with a trephine: a case series. Head Face Med. 2019 Dec 21;15(1):30. doi: 10.1186/s13005-019-0214-8.
PubMed 31861995Giacomino CM, Ray JJ, Wealleans JA. Targeted Endodontic Microsurgery: A Novel Approach to Anatomically Challenging Scenarios Using 3-dimensional-printed Guides and Trephine Burs-A Report of 3 Cases. J Endod. 2018 Apr;44(4):671-677. doi: 10.1016/j.joen.2017.12.019. Epub 2018 Feb 14.
PubMed 29426644Strbac GD, Schnappauf A, Giannis K, Moritz A, Ulm C. Guided Modern Endodontic Surgery: A Novel Approach for Guided Osteotomy and Root Resection. J Endod. 2017 Mar;43(3):496-501. doi: 10.1016/j.joen.2016.11.001. Epub 2017 Jan 28.
PubMed 28139285Kaddoura R, Lazkani T, Alsayed Tolibah Y. Effectiveness of guided endodontic microsurgery using a trephine bur in critical anatomical regions: a randomized controlled clinical trial. BDJ Open. 2026 Jul 14;12(1):71. doi: 10.1038/s41405-026-00461-w.
PubMed 42448657
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Guided Endodontic Microsurgery in Critical Anatomical Structures (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05283252
- Acronym / sponsor ID
- UDDS-Endo-01-2022
- Keywords
- Apicoectomy, Guided Endodontic Surgery, Micro-Surgery, Surgical Guide, 3-Dimensional Printed, Critical Structures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 16 Mar 2022 (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.
In recent years, there was a great interest in employing the surgical guide in dentistry due to the development occurred in the 3D printing which became available widely.
Cone beam computed tomography (CBCT) is necessary and crucial in planning for endodontic surgery, but the procedure still depends on how the surgeon reflect the 3D images on the anatomical structures accurately, which may leave room for error.
This study is to compare the clinical and radiographic outcomes using guided endodontic microsurgery versus conventional endodontic microsurgery in critical anatomical structures.
Detailed description
Endodontic microsurgery in critical anatomical structures is considered as a serious challenge for the endodontist.
Major advances have been made to the techniques used in endodontic surgery to make the procedure easier to perform, safer and more predictable.
Several case reports that used surgical guide in endodontic microsurgery found that the procedure was more accurate in control of depth, diameter and angle of osteotomy.
The aim of this study is to compare the clinical and radiographic outcomes using guided endodontic microsurgery versus conventional endodontic microsurgery in critical anatomical structures.
Patients will be selected that they are indicated for endodontic surgery. Upper and lower teeth will be selected close to critical anatomy such as; maxillary sinus, nasal fossa, mental foramen and mandibular canal. medical and dental history will be obtained from all selected patients. Patients will be randomly distributed to either guided micro-surgery group or conventional micro-surgery group. All steps of the surgical procedure will be performed under microscopic magnification. Bioceramic putty will be used as a root-end filling material. Post-surgical instructions will be given to patients. The time of the surgery will be recorded from the first incision to the last suturing. Success and failure will be assessed using radiographic and clinical evaluation at 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Guided Endodontic Micro-Surgery | Experimental | Device: 3-D printed GuideUse of the 3-D printed guide in endodontic micro-surgery |
| Conventional Endodontic Micro-Surgery | Placebo comparator | Other: Conventional Endodontic Micro-SurgeryFree-hand endodontic micro-surgery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients in good general health.
- Patients with age ranging between 18-50 years.
- Posterior/anterior teeth close to critical anatomical structures that indicated for endodontic surgery.
- Patients' acceptance to participate in the trail.
Key exclusion criteria (6 listed)
- Patients with allergy to materials or medications used in the trial.
- Patients with Serious systemic disease incompatible with surgery.
- Pregnant female patients.
- Teeth with periapical pathosis associated with vertical root fracture.
- Non-restorable teeth.
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 |
|---|---|---|
| 3-D printed GuideGuided Endodontic micro-surgery | Device | Guided Endodontic Micro-Surgery |
| Conventional Endodontic Micro-SurgeryFree-hand endodontic micro-surgery | Other | Conventional Endodontic Micro-Surgery |
Primary outcome
Clinical Success at two weeks
Time frame: Periodontal tissue healing will be evaluated clinically "2 weeks"
The position of the oral mucosa at the flap site will be assessed after surgery to evaluate wound healing using the wound healing index (WHI) by Huang et al 2005 as the following criteria: Score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence. Score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration. Score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration.
Clinical Success at one year
Time frame: Clinical signs or symptoms will be evaluated "1 year"
The patient's symptoms will be evaluated and the examination will be done on percussion, palpation and probing. Clinical Success will be defined as absence of pain, swelling or sensitivity on percussion. Clinical failure is the persistence of any of the above-mentioned symptoms.
Radiographic Success at 6 months
Time frame: Periapical tissues healing will be evaluated radiographically at 6 months after surgery
Early follow-up will be done and the initial radiographic Success or failure will be assessed. The size of periapical lesions/radiographic transparency will be measured in millimeters by periapical radiographs and CBCT images
Radiographic Success at 12 months
Time frame: Periapical tissues healing will be evaluated radiographically at 12 months after surgery
Radiographic Success will be defined as either complete or incomplete healing (formation of scar tissue). Radiographic Failure will involve either uncertain healing (small or constant lesion size) or unsatisfactory healing (increased lesion size). The size of periapical lesions/radiographic transparency will be measured in millimeters by periapical radiographs and CBCT images
2 secondary outcomes
Time of surgery
Time frame: During surgery
Change in Pain Perception
Time frame: Pain will be evaluated at 24, 48, and 72 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Background: PubMed 33548331Buniag AG, Pratt AM, Ray JJ. Targeted Endodontic Microsurgery: A Retrospective Outcomes Assessment of 24 Cases. J Endod. 2021 May;47(5):762-769. doi: 10.1016/j.joen.2021.01.007. Epub 2021 Feb 4.
- Background: PubMed 34289664Lio F, Mampieri G, Mazzetti V, Leggeri A, Arcuri L. Guided endodontic microsurgery in apicoectomy: a review. J Biol Regul Homeost Agents. 2021 May-Jun;35(3 Suppl. 1):47-55. doi: 10.23812/21-3supp1-7.
- Background: PubMed 31606146Popowicz W, Palatynska-Ulatowska A, Kohli MR. Targeted Endodontic Microsurgery: Computed Tomography-based Guided Stent Approach with Platelet-rich Fibrin Graft: A Report of 2 Cases. J Endod. 2019 Dec;45(12):1535-1542. doi: 10.1016/j.joen.2019.08.012. Epub 2019 Oct 9.
- Background: PubMed 31253911Monaghan L, Jadun S, Darcey J. Endodontic microsurgery. Part one: diagnosis, patient selection and prognoses. Br Dent J. 2019 Jun;226(12):940-948. doi: 10.1038/s41415-019-0415-3.
- Background: PubMed 31861995Antal M, Nagy E, Braunitzer G, Frater M, Piffko J. Accuracy and clinical safety of guided root end resection with a trephine: a case series. Head Face Med. 2019 Dec 21;15(1):30. doi: 10.1186/s13005-019-0214-8.
- Background: PubMed 29426644Giacomino CM, Ray JJ, Wealleans JA. Targeted Endodontic Microsurgery: A Novel Approach to Anatomically Challenging Scenarios Using 3-dimensional-printed Guides and Trephine Burs-A Report of 3 Cases. J Endod. 2018 Apr;44(4):671-677. doi: 10.1016/j.joen.2017.12.019. Epub 2018 Feb 14.
- Background: PubMed 28139285Strbac GD, Schnappauf A, Giannis K, Moritz A, Ulm C. Guided Modern Endodontic Surgery: A Novel Approach for Guided Osteotomy and Root Resection. J Endod. 2017 Mar;43(3):496-501. doi: 10.1016/j.joen.2016.11.001. Epub 2017 Jan 28.
- Derived from this study: PubMed 42448657Kaddoura R, Lazkani T, Alsayed Tolibah Y. Effectiveness of guided endodontic microsurgery using a trephine bur in critical anatomical regions: a randomized controlled clinical trial. BDJ Open. 2026 Jul 14;12(1):71. doi: 10.1038/s41405-026-00461-w.
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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.
Rami Kaddoura, DDS,MSc principal investigator
Damascus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-D printed Guide and Conventional Endodontic Micro-Surgery in people with Endodontic Disease and Endodontic Re-treatment Failure, run by Damascus University at 1 site in Syria.
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 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: finished, as of the sponsor's last update on 29 Sep 2023. 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 Syria. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Success at two weeks (time frame: Periodontal tissue healing will be evaluated clinically "2 weeks"). The study lists 4 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 NCT05283252, which also lists 8 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 29 Sep 2023.