Effectiveness of Microscope During Apical Surgery in Endodontic Treated Teeth.NCT01759069
RCT: Effectiveness of a Microscope During Dental Root Apical Surgery
A study testing Surgical treatment with microscope in people with Effectiveness of Microscope During Apical Surgery in Endodontic Treated Teeth., run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
An endodontic treatment is the standard therapy for teeth with periapical periodontitis. The overall success rate for this treatment is high; 97% of the treated teeth are retained in the oral cavity after 8 years (Salehrabi \& Rotstein, 2004). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Effectiveness of Microscope During Apical Surgery in Endodontic Treated Teeth.
- What is being tested?
- Surgical treatment with microscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2012to Dec 2015
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Peri-apical lesion on one of the teeth, confirmed on radiograph.
- Previous endodontic treatment was more than 6 months earlier.
Who cannot join
- Root fracture.
- Periodontal origin of apical infection or absence of marginal buccal bone after flap elevation.
- Root perforation.
- No previous endodontic treatment.
- Previous endodontic surgery.
Trial locations and contacts
1 site in 1 country.
M.H.T. de Ruiter, Drs. contact
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center; Clinic of Oral and Maxillofacial Surgery
Amsterdam, 1105 AZ
M.H.T. de Ruiter, Drs.
About this study
Official title: The Effectiveness of a Microscope During Apical Surgery; a Prospective Randomized Controlled Clinical Trial.
An endodontic treatment is the standard therapy for teeth with periapical periodontitis. The overall success rate for this treatment is high; 97% of the treated teeth are retained in the oral cavity after 8 years (Salehrabi \& Rotstein, 2004). However, there are teeth that have a persistent granuloma because of various reasons and need endodontic retreatment or apical surgery. Overall results in literature for an endodontic retreatment show a success rate of 77%-89% (Ng, Mann, \& Gulabivala, 2008; Salehrabi \& Rotstein, 2010), the results of apical surgery are more or less similar (von Arx, 2005). Which of the two methods is preferred for failed root canal treatments is dependant on a variety of reasons. (For example an amount of gutta-percha outside the apex of the root is better corrected by apical surgery. Persistent infection as a result of insufficient gutta-percha amounts in a treated root is best treated with an endodontic retreatment.) The overall results in apical surgery have increased the past years due to better preparation of the apical end of the root by the use of an ultrasonic device (de Lange, Putters, Baas, \& van Ingen, 2007) and new materials that are used for filling of the rootend e.g. MTA (von Arx, Hanni, \& Jensen, 2010)
Objective of the study:
The objective of this study is to assess whether or not apical surgery that is carried out with the help of a microscope has a higher success rate than apical surgery without the use of a microscope. No RCT is found in present literature (Del Fabbro, Taschieri, Lodi, Banfi, \& Weinstein, 2009).
- Being tested
- Surgical treatment with microscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatment with microscopeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| treatment with microscope | Experimental | treatment with microscope Receives: Procedure: Surgical treatment with microscope |
| treatment without microscope | Experimental | treatment without microscope Receives: Procedure: Surgical treatment with microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success is measured by Clinical outcome and radiographic assessment.
A radiograph of the treated tooth is made directly post-operative, after 6 months and after 1 year post treatment. Clinical examination is performed at 6 months and 1 year after the operation.
Measured: 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effectiveness of Microscope During Apical Surgery in Endodontic Treated Teeth.Studies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.H.T. de Ruiter, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759069
- Sponsor's protocol ID
- Microscope
- Status last verified
- Jan 2014
- First submitted
- 24 Dec 2012
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Microscope During Apical Surgery; a Prospective Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT01759069
- Acronym / sponsor ID
- Microscope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 2 Jan 2013 (estimated)
- 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.
An endodontic treatment is the standard therapy for teeth with periapical periodontitis. The overall success rate for this treatment is high; 97% of the treated teeth are retained in the oral cavity after 8 years (Salehrabi \& Rotstein, 2004). However, there are teeth that have a persistent granuloma because of various reasons and need endodontic retreatment or apical surgery. Overall results in literature for an endodontic retreatment show a success rate of 77%-89% (Ng, Mann, \& Gulabivala, 2008; Salehrabi \& Rotstein, 2010), the results of apical surgery are more or less similar (von Arx, 2005). Which of the two methods is preferred for failed root canal treatments is dependant on a variety of reasons. (For example an amount of gutta-percha outside the apex of the root is better corrected by apical surgery. Persistent infection as a result of insufficient gutta-percha amounts in a treated root is best treated with an endodontic retreatment.) The overall results in apical surgery have increased the past years due to better preparation of the apical end of the root by the use of an ultrasonic device (de Lange, Putters, Baas, \& van Ingen, 2007) and new materials that are used for filling of the rootend e.g. MTA (von Arx, Hanni, \& Jensen, 2010)
Objective of the study:
The objective of this study is to assess whether or not apical surgery that is carried out with the help of a microscope has a higher success rate than apical surgery without the use of a microscope. No RCT is found in present literature (Del Fabbro, Taschieri, Lodi, Banfi, \& Weinstein, 2009).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment with microscope | Experimental | Procedure: Surgical treatment with microscopetreatment with microscope |
| treatment without microscope | Experimental | Procedure: Surgical treatment with microscopetreatment without microscope |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Peri-apical lesion on one of the teeth, confirmed on radiograph.
- Previous endodontic treatment was more than 6 months earlier.
Key exclusion criteria (5 listed)
- Root fracture.
- Periodontal origin of apical infection or absence of marginal buccal bone after flap elevation.
- Root perforation.
- No previous endodontic treatment.
- Previous endodontic surgery.
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 |
|---|---|---|
| Surgical treatment with microscope | Procedure or surgery | treatment with microscope, treatment without microscope |
Primary outcome
Success is measured by Clinical outcome and radiographic assessment.
Time frame: 6 months and 1 year
A radiograph of the treated tooth is made directly post-operative, after 6 months and after 1 year post treatment. Clinical examination is performed at 6 months and 1 year after the operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
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.
M.H.T. de Ruiter, Drs. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical treatment with microscope in people with Effectiveness of Microscope During Apical Surgery in Endodontic Treated Teeth., run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 2 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 20 Jan 2014. 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 Netherlands. 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 M.H.T. de Ruiter, Drs. (m.h.deruiter@amc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success is measured by Clinical outcome and radiographic assessment. (time frame: 6 months and 1 year). 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 20 Jan 2014.