ApexificationPhase 4NCT01817413
Comparison of Two Dental Techniques Used to Treat Teeth Which Have Become Infected or Painful Following Trauma
A Phase 4 study testing Mineral trioxide aggregate and Revascularisation in people with Apexification and Apexogenesis, run by University of Liverpool at 1 site in United Kingdom.
Trial summary
Children often damage their front teeth. In approximately 6% of cases, the nerve inside the affected tooth dies (becomes 'non-vital') and natural root development stops. In these cases, the tooth requires a root canal treatment in order to prevent problems such as pain and dental abscesses from arising. Read more about this study
- Who is it for?
- Ages 7 to 25 years
- Conditions the study is for
- Apexification, Apexogenesis, Pulp Necrosis
- What is being tested?
- Mineral trioxide aggregate and Revascularisation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2011to Aug 2015
- Phase
- Phase 4
- 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 7 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between 7 and 25 years of age
- Have no significant medical history
- Cooperative in the dental chair
- Able to commit to the recall schedules prescribed by the study
- Have one or more traumatised non-vital permanent maxillary central incisors with incomplete root development
Who cannot join
- Have a medical history that may complicate treatment
- Have a medical history for which the study procedures may place the patient at increased risk
- Have a diagnosis of avulsion or severe intrusion following dental trauma
- Exclusion Criteria for Permanent maxillary central incisors:
- Less than half formed
- Have anatomical complexity (such as dens invaginatus)
- Have horizontal or vertical root fractures present
- Have evidence of root resorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Revascularisation Versus Mineral Trioxide Aggregate in the Management of Non-Vital Immature Permanent Incisors in a Young Population: A Randomised Controlled Trial (Pilot Study)
Children often damage their front teeth. In approximately 6% of cases, the nerve inside the affected tooth dies (becomes 'non-vital') and natural root development stops. In these cases, the tooth requires a root canal treatment in order to prevent problems such as pain and dental abscesses from arising. However, because the roots of these young teeth are not fully formed, they are weaker and prone to fracture. In addition, root canal treatment is difficult because a root canal filling cannot be placed in a tooth which is not yet fully formed, due to the fact that the root has an 'open' end.
To enable root canal treatment to be carried out, a 'barrier' must be placed at the end of the 'open' root. This can be done using materials called Calcium Hydroxide or Mineral Trioxide Aggregate (MTA). These materials are placed inside the root and sealed into the tooth. However, although they help to provide a barrier, they do not help to strengthen the walls of the root. Treatment with these materials requires multiple visits to the dentist, over a period of up to 18 months.
Read more
There is evidence to suggest that an alternative treatment involving 'revascularisation' (recovery of the blood supply to the tooth) and the use of a triple antibiotic paste allows 'natural' root growth to restart, and also strengthens the walls of the root. Treatment can often be carried out in just two visits.
The aim of this study is to discover whether there is a difference between one of two methods of treating non-vital teeth with open ends. It is thought that there will be no significant differences seen between the results of the two techniques.
Children with teeth that fall into this category and require root canal treatment will be given one of two treatments, both of which aim to treat infection, close the root end and to allow healing to take place.
Teeth will receive one of the following methods of root treatment:
- Revascularisation (recovery of the natural blood supply to the tooth) following placement of an antibiotic paste into the tooth root. The aim of this treatment is to allow 'natural' root growth to restart. Root growth will allow the tooth to form at barrier at the end of the root. No root canal filling will then be necessary.
- Closure of the open root end by placement of an artificial barrier at the end of the root so that a root canal filling can then be placed. This will be done with a dental material called Mineral Trioxide Aggregate (MTA). Non-vital teeth with an open end are routinely treated in this way at Liverpool Dental Hospital.
Read the detailed description
Participants will be randomly allocated in to one of the above treatment groups. This means that neither the participants, nor the researchers, will be able to choose which group a participant will be allocated to.
In both techniques, in order to learn about the bacteria involved in non-vital teeth, the investigators will take samples of the bacteria within the root canal.
The outcomes of the study will provide us with further information about root growth, the bacteria involved in infection of non-vital teeth and the success of the different treatment methods that are available. This information will enable us to increase our understanding of the treatment of non-vital teeth with an open end and help us to explain our treatments to future patients.
All children presenting to Liverpool University Dental Hospital aged between 7 and 25 years of age and who are medically well and cooperative to receive prolonged treatment in the dental chair are eligible to take part in the study if they have a damaged upper front adult tooth in which the nerve has died and the root is open ended. Unfortunately, if there is dental decay in the tooth or a fracture of the root then these teeth are not suitable for this study. In some cases following damage to a tooth, the root of the tooth starts to dissolve and unfortunately these teeth are also not suitable for this study.
Suitable patients attend with their parent or carer for a consultation to the Paediatric Dentistry Clinic at Liverpool University Dental Hospital. Following this visit, if a suitable patient wishes to join our study the investigators will arrange two further visits during which the dental treatment will take place. Following completion of treatment, patients will be asked to return for four check ups over the next year so that the investigators can check that they are happy and that treatment has been successful.
There are no risks or disadvantages to taking part in this study. However, if the tooth does not respond to treatment, or if symptoms of infection arise, then alternative treatment methods may be initiated as necessary.
The study is being funded by the Royal Liverpool and Broadgreen University Hospitals NHS Trust and by the University of Liverpool.
- Conditions
- Apexification, Apexogenesis, Pulp Necrosis, MTA, Pulp Revascularisation, Periapical Periodontitis
- Being tested
- Mineral trioxide aggregate, Revascularisation
- Keywords
- Calcium hydroxide, Pulp regeneration, Regenerative endodontics, Pulp revitalisation, Triple antibiotic paste, Root canal therapy, Root end closure, Tooth root, Tooth apex, Dental trauma, Non-vital, Immature, Incisor, Periapical periodontitis, Dental pulp
- Medical subject headings
- Dental Pulp Necrosis, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineral trioxide aggregateProcedure or surgery
Also called MTA, MTA cement, Apexification
An apical barrier of mineral trioxide aggregate (MTA cement) will be placed in the tooth root at the open apex in order to achieve root end closure via an apexification technique
RevascularisationProcedure or surgery
Also called Regenerative endodontics, Pulp revitalisation, Apexogenesis
Pulp revascularisation will be induced by instrumentation through the open apex so that a blood clot forms within the root canal in order to achieve root end closure via apexogenesis
| Study group | Role | What they receive |
|---|---|---|
| Apexification with MTA | Active comparator | The control group will receive:
Visit 1: root canal dressing with calcium hydroxide Visit 2: apexification with mineral trioxide aggregate (MTA), followed by obturation of the root canal with gutta percha.
Treatment will be carried out over two visits, two weeks apart. Receives: Procedure: Mineral trioxide aggregate |
| Pulp revascularisation | Experimental | The experimental group will receive:
Visit 1: root canal dressing with triple antibiotic paste Visit 2: pulp revascularisation procedure Treatment will be carried out over two visits, two weeks apart. Receives: Procedure: Revascularisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of periapical healing
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress.
Final outcome measures will be recorded at 12 months.
Measured: 12 months
Presence of a satisfactory apical barrier
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress.
Final outcome measures will be recorded at 12 months.
Measured: 12 months
Secondary outcomes (4)
Patient satisfaction
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress.
Final outcome measures will be recorded at 12 months.
Measured: 12 months
Evidence of root development
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress.
Final outcome measures will be recorded at 12 months.
Measured: 12 months
A satisfactorily restored tooth
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress.
Final outcome measures will be recorded at 12 months.
Measured: 12 months
Absence of signs and symptoms of failure of treatment (pain, mobility, tenderness to percussion, pathology e.g.sinus or swelling)
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress.
Final outcome measures will be recorded at 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startFeb 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApexificationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Laura Gartshore, University of Liverpool
- Investigators
- C C Youngson, Study chair, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817413
- Sponsor's protocol ID
- RD&I 3968, UoL000590
- Other IDs
- Controlled Trials
- Status last verified
- Dec 2015
- First submitted
- 18 Mar 2013
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revascularisation Versus Mineral Trioxide Aggregate in the Management of Non-Vital Immature Permanent Incisors in a Young Population: A Randomised Controlled Trial (Pilot Study)
- ClinicalTrials.gov ID
- NCT01817413
- Acronym / sponsor ID
- RD&I 3968, UoL000590
- Conditions
- Apexification, Apexogenesis, Pulp Necrosis, MTA, Pulp Revascularisation, Periapical Periodontitis
- Keywords
- Calcium hydroxide, Pulp regeneration, Regenerative endodontics, Pulp revitalisation, Triple antibiotic paste, Root canal therapy, Root end closure, Tooth root
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Study start
- Feb 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Mar 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.
Children often damage their front teeth. In approximately 6% of cases, the nerve inside the affected tooth dies (becomes 'non-vital') and natural root development stops. In these cases, the tooth requires a root canal treatment in order to prevent problems such as pain and dental abscesses from arising. However, because the roots of these young teeth are not fully formed, they are weaker and prone to fracture. In addition, root canal treatment is difficult because a root canal filling cannot be placed in a tooth which is not yet fully formed, due to the fact that the root has an 'open' end.
To enable root canal treatment to be carried out, a 'barrier' must be placed at the end of the 'open' root. This can be done using materials called Calcium Hydroxide or Mineral Trioxide Aggregate (MTA). These materials are placed inside the root and sealed into the tooth. However, although they help to provide a barrier, they do not help to strengthen the walls of the root. Treatment with these materials requires multiple visits to the dentist, over a period of up to 18 months.
There is evidence to suggest that an alternative treatment involving 'revascularisation' (recovery of the blood supply to the tooth) and the use of a triple antibiotic paste allows 'natural' root growth to restart, and also strengthens the walls of the root. Treatment can often be carried out in just two visits.
The aim of this study is to discover whether there is a difference between one of two methods of treating non-vital teeth with open ends. It is thought that there will be no significant differences seen between the results of the two techniques.
Children with teeth that fall into this category and require root canal treatment will be given one of two treatments, both of which aim to treat infection, close the root end and to allow healing to take place.
Teeth will receive one of the following methods of root treatment:
- Revascularisation (recovery of the natural blood supply to the tooth) following placement of an antibiotic paste into the tooth root. The aim of this treatment is to allow 'natural' root growth to restart. Root growth will allow the tooth to form at barrier at the end of the root. No root canal filling will then be necessary.
- Closure of the open root end by placement of an artificial barrier at the end of the root so that a root canal filling can then be placed. This will be done with a dental material called Mineral Trioxide Aggregate (MTA). Non-vital teeth with an open end are routinely treated in this way at Liverpool Dental Hospital.
Detailed description
Participants will be randomly allocated in to one of the above treatment groups. This means that neither the participants, nor the researchers, will be able to choose which group a participant will be allocated to.
In both techniques, in order to learn about the bacteria involved in non-vital teeth, the investigators will take samples of the bacteria within the root canal.
The outcomes of the study will provide us with further information about root growth, the bacteria involved in infection of non-vital teeth and the success of the different treatment methods that are available. This information will enable us to increase our understanding of the treatment of non-vital teeth with an open end and help us to explain our treatments to future patients.
All children presenting to Liverpool University Dental Hospital aged between 7 and 25 years of age and who are medically well and cooperative to receive prolonged treatment in the dental chair are eligible to take part in the study if they have a damaged upper front adult tooth in which the nerve has died and the root is open ended. Unfortunately, if there is dental decay in the tooth or a fracture of the root then these teeth are not suitable for this study. In some cases following damage to a tooth, the root of the tooth starts to dissolve and unfortunately these teeth are also not suitable for this study.
Suitable patients attend with their parent or carer for a consultation to the Paediatric Dentistry Clinic at Liverpool University Dental Hospital. Following this visit, if a suitable patient wishes to join our study the investigators will arrange two further visits during which the dental treatment will take place. Following completion of treatment, patients will be asked to return for four check ups over the next year so that the investigators can check that they are happy and that treatment has been successful.
There are no risks or disadvantages to taking part in this study. However, if the tooth does not respond to treatment, or if symptoms of infection arise, then alternative treatment methods may be initiated as necessary.
The study is being funded by the Royal Liverpool and Broadgreen University Hospitals NHS Trust and by the University of Liverpool.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apexification with MTA | Active comparator | Procedure: Mineral trioxide aggregateThe control group will receive: Visit 1: root canal dressing with calcium hydroxide Visit 2: apexification with mineral trioxide aggregate (MTA), followed by obturation of the root canal with gutta percha. Treatment will be carried out over two visits, two weeks apart. |
| Pulp revascularisation | Experimental | Procedure: RevascularisationThe experimental group will receive: Visit 1: root canal dressing with triple antibiotic paste Visit 2: pulp revascularisation procedure Treatment will be carried out over two visits, two weeks apart. |
Who may qualify
- Ages
- 7 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Between 7 and 25 years of age
- Have no significant medical history
- Cooperative in the dental chair
- Able to commit to the recall schedules prescribed by the study
- Have one or more traumatised non-vital permanent maxillary central incisors with incomplete root development
Key exclusion criteria (8 listed)
- Have a medical history that may complicate treatment
- Have a medical history for which the study procedures may place the patient at increased risk
- Have a diagnosis of avulsion or severe intrusion following dental trauma
- Less than half formed
- Have anatomical complexity (such as dens invaginatus)
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 |
|---|---|---|
| Mineral trioxide aggregateAlso: MTA, MTA cement, ApexificationAn apical barrier of mineral trioxide aggregate (MTA cement) will be placed in the tooth root at the open apex in order to achieve root end closure via an apexification technique | Procedure or surgery | Apexification with MTA |
| RevascularisationAlso: Regenerative endodontics, Pulp revitalisation, ApexogenesisPulp revascularisation will be induced by instrumentation through the open apex so that a blood clot forms within the root canal in order to achieve root end closure via apexogenesis | Procedure or surgery | Pulp revascularisation |
Primary outcome
Evidence of periapical healing
Time frame: 12 months
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress. Final outcome measures will be recorded at 12 months.
Presence of a satisfactory apical barrier
Time frame: 12 months
Teeth will be reviewed clinically and radiographically at 3, 6, 9 and 12 months in order to monitor healing progress. Final outcome measures will be recorded at 12 months.
4 secondary outcomes
Patient satisfaction
Time frame: 12 months
Evidence of root development
Time frame: 12 months
A satisfactorily restored tooth
Time frame: 12 months
Absence of signs and symptoms of failure of treatment (pain, mobility, tenderness to percussion, pathology e.g.sinus or swelling)
Time frame: 12 months
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 10 Dec 2015.
- Current Controlled Trials RegistrationLink provided by the sponsor.
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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.
C C Youngson study chair
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mineral trioxide aggregate and Revascularisation in people with Apexification and Apexogenesis, run by University of Liverpool at 1 site in United Kingdom.
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 5 inclusion and 8 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 10 Dec 2015. 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 United Kingdom. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evidence of periapical healing (time frame: 12 months). 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 10 Dec 2015.