Endodontic DiseaseNCT04133181
Guided Versus Conventional Periapical Endodontic Surgery
A study testing 3D guide and Mock guide in people with Endodontic Disease and Endodontic Re-treatment Failure, run by Cairo University.
Trial summary
This study is to compare the clinical and radiographic outcomes after guided periapical endodontic surgery versus conventional endodontic surgery. 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?
- 3D guide and Mock guide
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Oct 2021
- 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 with no sex predilection.
- Posterior teeth with an indication for endodontic surgery.
- Patients' acceptance to participate in the study.
Who cannot join
- Patients with allergy to materials or medications used in the trial.
- Pregnant female patients.
- Teeth with pathoses associated with vertical root fracture.
- Severe periodontal bone loss detected with a periodontal probe (5 mm probing depth).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical and Radiographic Success of Guided Versus Conventional Periapical Endodontic Surgery: A Randomized Controlled Trial
This study is to compare the clinical and radiographic outcomes after guided periapical endodontic surgery versus conventional endodontic surgery.
Read the detailed description
The aim of this study is to compare the clinical and radiographic outcomes after guided periapical endodontic surgery versus conventional endodontic surgery. Patients having mandibular posterior teeth indicated for endodontic surgery will be selected. Full medical and dental history will be obtained from all patients. Patients will be randomly assigned to either guided endodontic surgery or conventional endodontic surgery. Surgical procedures will be done under magnification. Root-end cavities will be filled using MTA.Post surgical instrucions will be given to patients. Surgical time will be recorded. Clinical and radiographic success will be asses at 6 and 12 month.
- Being tested
- 3D guide, Mock guide
- Keywords
- Endodontic surgery, Guided surgery, 3D guide
- 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.
3D guideDevice
Use of a 3D guide in endodontic surgery
Mock guideDevice
Use of a mock guide in endodontic surgery
| Study group | Role | What they receive |
|---|---|---|
| Guided endodontic surgery | Experimental | Use of a 3D surgical guide in endodontic surgery Receives: Device: 3D guide |
| Conventional endodontic surgery | Placebo comparator | Use of a mock guide in endodontic surgery Receives: Device: Mock guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
Clinical assessment using a scale by friedman et al 2005 (healed, healing and persisting disease) which healed mean absence of clinical signs and symptoms, persisting disease mean presence of clinical signs and symptoms
Measured: 1 year
Radio graphic Success
Radiograhic assessment using a scale by friedman et al 2005 (healed, healing and persisting disease) which healed mean radiographic classification of complete healing or incomplete healing, persisting disease mean radiographic classification of unsatisfactory healing.
Measured: 1 year
Secondary outcomes (1)
Time of surgery
Recording the surgical time in minutes.
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 posted21 Oct 2019
- Study startDec 2019 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endodontic DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed meneisy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133181
- Sponsor's protocol ID
- Endosurgery
- Status last verified
- Oct 2019
- First submitted
- 17 Oct 2019
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anderson J, Wealleans J, Ray J. Endodontic applications of 3D printing. Int Endod J. 2018 Sep;51(9):1005-1018. doi: 10.1111/iej.12917. Epub 2018 Mar 23.
PubMed 29486052Strbac 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 28139285Ahn SY, Kim NH, Kim S, Karabucak B, Kim E. Computer-aided Design/Computer-aided Manufacturing-guided Endodontic Surgery: Guided Osteotomy and Apex Localization in a Mandibular Molar with a Thick Buccal Bone Plate. J Endod. 2018 Apr;44(4):665-670. doi: 10.1016/j.joen.2017.12.009. Epub 2018 Jan 19.
PubMed 29358006
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Success of Guided Versus Conventional Periapical Endodontic Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04133181
- Acronym / sponsor ID
- Endosurgery
- Keywords
- Endodontic surgery, Guided surgery, 3D guide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 21 Oct 2019 (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 is to compare the clinical and radiographic outcomes after guided periapical endodontic surgery versus conventional endodontic surgery.
Detailed description
The aim of this study is to compare the clinical and radiographic outcomes after guided periapical endodontic surgery versus conventional endodontic surgery. Patients having mandibular posterior teeth indicated for endodontic surgery will be selected. Full medical and dental history will be obtained from all patients. Patients will be randomly assigned to either guided endodontic surgery or conventional endodontic surgery. Surgical procedures will be done under magnification. Root-end cavities will be filled using MTA.Post surgical instrucions will be given to patients. Surgical time will be recorded. Clinical and radiographic success will be asses at 6 and 12 month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided endodontic surgery | Experimental | Device: 3D guideUse of a 3D surgical guide in endodontic surgery |
| Conventional endodontic surgery | Placebo comparator | Device: Mock guideUse of a mock guide in endodontic 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 with no sex predilection.
- Posterior teeth with an indication for endodontic surgery.
- Patients' acceptance to participate in the study.
Key exclusion criteria (4 listed)
- Patients with allergy to materials or medications used in the trial.
- Pregnant female patients.
- Teeth with pathoses associated with vertical root fracture.
- Severe periodontal bone loss detected with a periodontal probe (5 mm probing depth).
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 |
|---|---|---|
| 3D guideUse of a 3D guide in endodontic surgery | Device | Guided endodontic surgery |
| Mock guideUse of a mock guide in endodontic surgery | Device | Conventional endodontic surgery |
Primary outcome
Clinical success
Time frame: 1 year
Clinical assessment using a scale by friedman et al 2005 (healed, healing and persisting disease) which healed mean absence of clinical signs and symptoms, persisting disease mean presence of clinical signs and symptoms
Radio graphic Success
Time frame: 1 year
Radiograhic assessment using a scale by friedman et al 2005 (healed, healing and persisting disease) which healed mean radiographic classification of complete healing or incomplete healing, persisting disease mean radiographic classification of unsatisfactory healing.
1 secondary outcome
Time of surgery
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 22 Oct 2019.
- Background: PubMed 29486052Anderson J, Wealleans J, Ray J. Endodontic applications of 3D printing. Int Endod J. 2018 Sep;51(9):1005-1018. doi: 10.1111/iej.12917. Epub 2018 Mar 23.
- 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.
- Background: PubMed 29358006Ahn SY, Kim NH, Kim S, Karabucak B, Kim E. Computer-aided Design/Computer-aided Manufacturing-guided Endodontic Surgery: Guided Osteotomy and Apex Localization in a Mandibular Molar with a Thick Buccal Bone Plate. J Endod. 2018 Apr;44(4):665-670. doi: 10.1016/j.joen.2017.12.009. Epub 2018 Jan 19.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing 3D guide and Mock guide in people with Endodontic Disease and Endodontic Re-treatment Failure, run by Cairo University.
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 4 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 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Meneisy, Master Degree (+201008143026, Ahmed.meneisy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: 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?
On the ClinicalTrials.gov record for NCT04133181, which also lists 3 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 22 Oct 2019.