Clinical trial NCT03700866: Evaluation of Functional Versus IADT Splinting Times on Tooth Mobility After Surgical Extrusion
Official title: Evaluation of Functional Versus IADT Splinting Times on Tooth Mobility After Surgical Extrusion of Permanent Anterior Teeth: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Trauma
Keywords: luxation injury
splinting time
crown-root fracture
surgical extrusion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 22
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tooth mobility
timeFrame: 3 months
measure: Tooth mobility
timeFrame: 6 months
measure: Tooth mobility
timeFrame: 9 months
Secondary outcomes:
measure: Root resorption
timeFrame: 9 months
measure: marginal bone resorption
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
References: