Dental TraumaNCT03700866
Evaluation of Functional Versus IADT Splinting Times on Tooth Mobility After Surgical Extrusion
A study testing Functional splinting time in people with Dental Trauma, run by Cairo University.
Trial summary
The objective of this study is to compare functional splinting time effect versus the suggested splinting time of (IADT) effect on tooth mobility and possible healing outcomes for surgically extruded permanent anterior teeth with crown root fracture. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Trauma
- What is being tested?
- Functional splinting time
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 30 Jan 2019
- 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 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Permanent anterior tooth/teeth with crown root fracture that needs surgical extrusion.
- Complicated or uncomplicated crown root fracture.
- Vital or necrotic tooth/ teeth.
- Mature or immature tooth /teeth.
Who cannot join
- Medically compromised patient
- Tooth suffered any type of luxation injury to decrease the risk of root resorption
- When root resorption is evident during the initial radiographic examination.
- Teeth with dilacerated root to avoid pulp necrosis and periapical infection that occur without any evident decay in these teeth as the central lumen of the root constitutes a pathway for bacteria.
- When root resorption is evident during the initial radiographic examination.
- Teeth with dilacerated root to avoid pulp necrosis and periapical infection that occur without any evident decay in these teeth as the central lumen of the root constitutes a pathway for bacteria.
About this study
Official title: Evaluation of Functional Versus IADT Splinting Times on Tooth Mobility After Surgical Extrusion of Permanent Anterior Teeth: A Randomized Controlled Trial
The objective of this study is to compare functional splinting time effect versus the suggested splinting time of (IADT) effect on tooth mobility and possible healing outcomes for surgically extruded permanent anterior teeth with crown root fracture.
Read the detailed description
Trauma involving the tooth supporting tissue, especially luxation injuries, is considered the most severe with consequences such as neurovascular disruption, pulp necrosis, and root resorption. Healing depends on factors such as the level of root development, the extent of damage to periodontal tissues, and the effects of bacterial contamination from the oral cavity .
The course of healing of the severed periodontal ligament will determine the treatment outcome of these injured teeth .As a result, all treatment procedures are directed to minimize undesired consequences which might lead not only to loss of tooth, but also to loss of alveolar bone.
The common treatment of luxated teeth is repositioning and splinting to achieve stability and to prevent further damage to the pulp and periodontal structures during healing. Splints should ensure adequate fixation, prevent accidental ingestion or inhalation, and should protect teeth against traumatic forces during the vulnerable healing period .
The current guidelines for treatment of traumatic injuries by the International Association of Dental Traumatology (IADT) specify a short term functional splint for luxated teeth. However these protocols are based on clinical studies and animal experimentation employed rigid fixation techniques so the results of these investigations are not representative of the current protocols . Also splinting times in IADT guidelines are derived mainly from animal studies which considered of low quality evidence .
As a result of, surgical tooth extrusion as treatment modality in cases of crown root fracture was chosen as a controlled traumatic injury to examine the true cause-effect relationship between splinting time and healing outcomes of periodontal ligament aiming to decrease the effect of bias, con-founders and probability of chance associated with the other types of luxation injury.
- Conditions
- Dental Trauma
- Being tested
- Functional splinting time
- Keywords
- luxation injury, splinting time, crown-root fracture, surgical extrusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional splinting timeProcedure or surgery
Functional splinting time is the time needed for the final healing and organization of Peridontal ligament of tooth with extrusive luxation injury to reattach to the alveolus and function normally in the oral cavity
| Study group | Role | What they receive |
|---|---|---|
| (Functional splinting time) | Experimental | Teeth with crown root fracture will be surgically extruded and splinted then the Periotest values will determine when the splint should be removed which will indicate the functional periodontal healing and as well the functional splinting time.
The Periotest readings will be repeated with one week time interval between each series When the Periotest values of the traumatized tooth reach or even approximate the values of the corresponding normal tooth the splint will be removed. Receives: Procedure: Functional splinting time |
| (IADT splinting time) | Active comparator | Teeth with crown root fracture in this group will be surgically extruded and splinted for two weeks according to the international association of dental traumatology (IADT) splinting time two ,weeks splinting, regardless the Periotest score. Receives: Procedure: Functional splinting time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth mobility
Tooth mobility will be assessed using Periotest the measurement unite is discrete range (-8 to 50)
Measured: 3 months
Tooth mobility
Tooth mobility will be assessed using Periotest the measurement unite is discrete range (-8 to 50)
Measured: 6 months
Tooth mobility
Tooth mobility will be assessed using Periotest the measurement unite is discrete range (-8 to 50)
Measured: 9 months
Secondary outcomes (2)
Root resorption
Root resorption will be assessed using digital radiography the outcome will be binary outcome (Present or Absent) using DIGORA software.
Measured: 9 months
marginal bone resorption
marginal bone resorption will be assessed using digital radiography the outcome will be binary outcome (Present or Absent) using DIGORA software.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Oct 2016
- Primary completion30 Jan 2019 (estimated)
- Study completion30 Jan 2019 (estimated)
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 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maii Mohamed Mohamed Mohamed Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700866
- Sponsor's protocol ID
- splinting time
- Status last verified
- Oct 2018
- First submitted
- 4 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functional Versus IADT Splinting Times on Tooth Mobility After Surgical Extrusion of Permanent Anterior Teeth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03700866
- Acronym / sponsor ID
- splinting time
- Conditions
- Dental Trauma
- Keywords
- luxation injury, splinting time, crown-root fracture, surgical extrusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Jan 2019 (estimated)
- Study completion
- 30 Jan 2019 (estimated)
- First posted
- 9 Oct 2018 (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.
The objective of this study is to compare functional splinting time effect versus the suggested splinting time of (IADT) effect on tooth mobility and possible healing outcomes for surgically extruded permanent anterior teeth with crown root fracture.
Detailed description
Trauma involving the tooth supporting tissue, especially luxation injuries, is considered the most severe with consequences such as neurovascular disruption, pulp necrosis, and root resorption. Healing depends on factors such as the level of root development, the extent of damage to periodontal tissues, and the effects of bacterial contamination from the oral cavity .
The course of healing of the severed periodontal ligament will determine the treatment outcome of these injured teeth .As a result, all treatment procedures are directed to minimize undesired consequences which might lead not only to loss of tooth, but also to loss of alveolar bone.
The common treatment of luxated teeth is repositioning and splinting to achieve stability and to prevent further damage to the pulp and periodontal structures during healing. Splints should ensure adequate fixation, prevent accidental ingestion or inhalation, and should protect teeth against traumatic forces during the vulnerable healing period .
The current guidelines for treatment of traumatic injuries by the International Association of Dental Traumatology (IADT) specify a short term functional splint for luxated teeth. However these protocols are based on clinical studies and animal experimentation employed rigid fixation techniques so the results of these investigations are not representative of the current protocols . Also splinting times in IADT guidelines are derived mainly from animal studies which considered of low quality evidence .
As a result of, surgical tooth extrusion as treatment modality in cases of crown root fracture was chosen as a controlled traumatic injury to examine the true cause-effect relationship between splinting time and healing outcomes of periodontal ligament aiming to decrease the effect of bias, con-founders and probability of chance associated with the other types of luxation injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Functional splinting time) | Experimental | Procedure: Functional splinting timeTeeth with crown root fracture will be surgically extruded and splinted then the Periotest values will determine when the splint should be removed which will indicate the functional periodontal healing and as well the functional splinting time. The Periotest readings will be repeated with one week time interval between each series When the Periotest values of the traumatized tooth reach or even approximate the values of the corresponding normal tooth the splint will be removed. |
| (IADT splinting time) | Active comparator | Procedure: Functional splinting timeTeeth with crown root fracture in this group will be surgically extruded and splinted for two weeks according to the international association of dental traumatology (IADT) splinting time two ,weeks splinting, regardless the Periotest score. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Permanent anterior tooth/teeth with crown root fracture that needs surgical extrusion.
- Complicated or uncomplicated crown root fracture.
- Vital or necrotic tooth/ teeth.
- Mature or immature tooth /teeth.
Key exclusion criteria (6 listed)
- Medically compromised patient
- Tooth suffered any type of luxation injury to decrease the risk of root resorption
- When root resorption is evident during the initial radiographic examination.
- Teeth with dilacerated root to avoid pulp necrosis and periapical infection that occur without any evident decay in these teeth as the central lumen of the root constitutes a pathway for bacteria.
- When root resorption is evident during the initial radiographic examination.
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 |
|---|---|---|
| Functional splinting timeFunctional splinting time is the time needed for the final healing and organization of Peridontal ligament of tooth with extrusive luxation injury to reattach to the alveolus and function normally in the oral cavity | Procedure or surgery | (Functional splinting time), (IADT splinting time) |
Primary outcome
Tooth mobility
Time frame: 3 months
Tooth mobility will be assessed using Periotest the measurement unite is discrete range (-8 to 50)
Tooth mobility
Time frame: 6 months
Tooth mobility will be assessed using Periotest the measurement unite is discrete range (-8 to 50)
Tooth mobility
Time frame: 9 months
Tooth mobility will be assessed using Periotest the measurement unite is discrete range (-8 to 50)
2 secondary outcomes
Root resorption
Time frame: 9 months
marginal bone resorption
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Functional splinting time in people with Dental Trauma, 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 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: status not confirmed, as of the sponsor's last update on 9 Oct 2018. 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. 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?
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?
Tooth mobility (time frame: 3 months). The study lists 3 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 9 Oct 2018.