Evaluation of Functional Versus IADT Splinting Times on Tooth Mobility After Surgical Extrusion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Functional Versus IADT Splinting Times on Tooth Mobility After Surgical Extrusion of Permanent Anterior Teeth: A Randomized Controlled Trial

Conditions
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Dental Trauma

Intervention / Treatment
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* Procedure: Functional splinting time


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (Functional splinting time)<br>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. | Procedure: Functional splinting time<br>* 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<br>|
| Active Comparator: (IADT splinting time)<br>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. | Procedure: Functional splinting time<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tooth mobility | Tooth mobility will be assessed using Periotest the measurement unite is discrete range (-8 to 50) | 3 months | 
| Tooth mobility | Tooth mobility will be assessed using Periotest the measurement unite is discrete range (-8 to 50) | 6 months | 
| Tooth mobility | Tooth mobility will be assessed using Periotest the measurement unite is discrete range (-8 to 50) | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Root resorption | Root resorption will be assessed using digital radiography the outcome will be binary outcome (Present or Absent) using DIGORA software. | 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. | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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luxation injury, splinting time, crown-root fracture, surgical extrusion