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

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.

Study Overview

• Status: Unknown
• Conditions: Dental Trauma
• Intervention / Treatment: Procedure: Functional splinting time

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 Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: (Functional splinting time); 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; 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
Active Comparator: (IADT splinting time); 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Anticipated): January 30, 2019
• Study Completion (Anticipated): January 30, 2019

Study Registration Dates

• First Submitted: October 4, 2018
• First Submitted That Met QC Criteria: October 6, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 6, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: surgical extrusion; luxation injury; splinting time; crown-root fracture
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Mobility
• Other Study ID Numbers: splinting time

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No