Dental TraumaTRAUMANCT03845426
Factors Affecting the Pulpal Prognosis of Injured Teeth
An observational study of Dental Trauma, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Factors affecting the pulpal prognosis of injured teeth. Dental injuries may affect the survival of teeth. It is recommended to monitor the injured teeth at regular intervals to ensure that the appropriate treatment is delivered promptly. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Trauma
- What is being tested?
- Root canal treatment.
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Feb 2019to 1 Mar 2020
- Phase
- Observational
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients will be recruited from the dental trauma clinic, which runs every Monday in Edinburgh Dental Institute.
Who may be able to join
- patients that have suffered dental trauma (lateral luxation)
- patients must have attended the Dental Trauma clinic within 2 weeks form the presenting injury
- patients should re-attend for review and monitor of teeth for at least 3 months following the injury
- patients older than 16 years old
- patients that have signed the informed consent
Who cannot join
- patients presented more than 2 weeks following the injury
- patients suffered from injuries other than lateral luxation
- patients younger than 16 years old
- adults with incapacity
- patient that have not consented to take part
Trial locations and contacts
1 site in 1 country.
About this study
Factors affecting the pulpal prognosis of injured teeth. Dental injuries may affect the survival of teeth. It is recommended to monitor the injured teeth at regular intervals to ensure that the appropriate treatment is delivered promptly. In order to conclude what treatment is required, a correct diagnosis must be reached.
However, reaching this diagnosis can be difficult as injured teeth often respond erroneously to many of the diagnostic tests used, thereby affecting our ability to interpret the results.
Read more
This study aims to identify the clinical factors that affect the ability of the blood supply of a tooth to survive an injury. This will help ensure that patients are provided with the appropriate treatment with the avoidance of delays that may affect the long-term survival of the tooth.
Patients that attend the Edinburgh Dental Institute trauma clinic will be invited to participate in this study. The patients, seen on this clinic, are assessed in regular intervals in a systematic way, as per accepted and validated international guidelines on the subject of dental trauma. There are specific investigations and clinical assessments that are carried out on the initial and each review appointment.
The study will attempt to identify those teeth that lose their vitality at different points following the injury and will attempt to link this to the nature of the injury suffered. The data will be collected from the patients' routine dental trauma assessment and no additional investigations will be required. As per routine practice the patients are reviewed for one year following their injury unless otherwise indicated. All responses to the investigations will be collected and combined to identify the prognostic factors associated with the loss of vitality of traumatised teeth.
Read the detailed description
Dento-alveolar trauma may affect the quality of life of patients and the long term prognosis of the teeth. Following dental trauma regular monitoring and follow up of the teeth is required to ensure that the appropriate treatment is delivered promptly. Although there is information in the literature focused on child and adolescent dental trauma, there is limited information regarding traumatised permanent teeth. Permanent teeth have differing healing capacity after injury and this is dependent on the degree of root formation.
During the initial assessment of patients that have suffered from dental trauma, negative responses to investigations assessing the health of the vasculature might lead clinicians to initiate unnecessary and irreversible treatment on traumatised teeth. Equally false positive results might delay treatment which might have an effect on the outcome, leading to the development of healing complications such as infection and root resorption. By collecting and analysing the clinical factors, we aim to identify which of aspects of the assessment might influence the prognoses of the teeth.
- Conditions
- Dental Trauma
- Being tested
- Root canal treatment.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal treatment.Other
Once pulpal necrosis has been diagnosed, root canal treatment will be carried out by the patient's general practitioner. This is an end point for the tooth in the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulpal necrosis
Number of participants developing pulpal necrosis following lateral luxations tooth injuries
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start25 Feb 2019
- Primary completion1 Feb 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental TraumaStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Robert Philpott, BDS,, Principal investigator, bob.philpott@ed.ac.uk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845426
- Sponsor's protocol ID
- AC18118
- Acronym
- TRAUMA
- Status last verified
- Jun 2020
- First submitted
- 18 Feb 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting the Pulpal Prognosis of Injured Teeth
- ClinicalTrials.gov ID
- NCT03845426
- Acronym / sponsor ID
- TRAUMA / AC18118
- Conditions
- Dental Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 19 Feb 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.
Factors affecting the pulpal prognosis of injured teeth. Dental injuries may affect the survival of teeth. It is recommended to monitor the injured teeth at regular intervals to ensure that the appropriate treatment is delivered promptly. In order to conclude what treatment is required, a correct diagnosis must be reached.
However, reaching this diagnosis can be difficult as injured teeth often respond erroneously to many of the diagnostic tests used, thereby affecting our ability to interpret the results.
This study aims to identify the clinical factors that affect the ability of the blood supply of a tooth to survive an injury. This will help ensure that patients are provided with the appropriate treatment with the avoidance of delays that may affect the long-term survival of the tooth.
Patients that attend the Edinburgh Dental Institute trauma clinic will be invited to participate in this study. The patients, seen on this clinic, are assessed in regular intervals in a systematic way, as per accepted and validated international guidelines on the subject of dental trauma. There are specific investigations and clinical assessments that are carried out on the initial and each review appointment.
The study will attempt to identify those teeth that lose their vitality at different points following the injury and will attempt to link this to the nature of the injury suffered. The data will be collected from the patients' routine dental trauma assessment and no additional investigations will be required. As per routine practice the patients are reviewed for one year following their injury unless otherwise indicated. All responses to the investigations will be collected and combined to identify the prognostic factors associated with the loss of vitality of traumatised teeth.
Detailed description
Dento-alveolar trauma may affect the quality of life of patients and the long term prognosis of the teeth. Following dental trauma regular monitoring and follow up of the teeth is required to ensure that the appropriate treatment is delivered promptly. Although there is information in the literature focused on child and adolescent dental trauma, there is limited information regarding traumatised permanent teeth. Permanent teeth have differing healing capacity after injury and this is dependent on the degree of root formation.
During the initial assessment of patients that have suffered from dental trauma, negative responses to investigations assessing the health of the vasculature might lead clinicians to initiate unnecessary and irreversible treatment on traumatised teeth. Equally false positive results might delay treatment which might have an effect on the outcome, leading to the development of healing complications such as infection and root resorption. By collecting and analysing the clinical factors, we aim to identify which of aspects of the assessment might influence the prognoses of the teeth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be recruited from the dental trauma clinic, which runs every Monday in Edinburgh Dental Institute.
Key inclusion criteria (5 listed)
- patients that have suffered dental trauma (lateral luxation)
- patients must have attended the Dental Trauma clinic within 2 weeks form the presenting injury
- patients should re-attend for review and monitor of teeth for at least 3 months following the injury
- patients older than 16 years old
- patients that have signed the informed consent
Key exclusion criteria (5 listed)
- patients presented more than 2 weeks following the injury
- patients suffered from injuries other than lateral luxation
- patients younger than 16 years old
- adults with incapacity
- patient that have not consented to take part
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 |
|---|---|---|
| Root canal treatment.Once pulpal necrosis has been diagnosed, root canal treatment will be carried out by the patient's general practitioner. This is an end point for the tooth in the study. | Other | – |
Primary outcome
Pulpal necrosis
Time frame: 3 months
Number of participants developing pulpal necrosis following lateral luxations tooth injuries
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 4 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
Robert Philpott, BDS, principal investigator
bob.philpott@ed.ac.uk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Trauma, run by University of Edinburgh 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 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: finished, as of the sponsor's last update on 4 Jun 2020. 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.
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?
Pulpal necrosis (time frame: 3 months). 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 4 Jun 2020.