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

Dental Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03700866
• Other study ID #: splinting time
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: January 30, 2019

Study information

• Verified date: October 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Trauma
• Tooth Mobility

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tooth mobility	Tooth mobility will be assessed using Periotest the measurement unite is discrete range (-8 to 50)	3 months
Primary	Tooth mobility	Tooth mobility will be assessed using Periotest the measurement unite is discrete range (-8 to 50)	6 months
Primary	Tooth mobility	Tooth mobility will be assessed using Periotest the measurement unite is discrete range (-8 to 50)	9 months
Secondary	Root resorption	Root resorption will be assessed using digital radiography the outcome will be binary outcome (Present or Absent) using DIGORA software.	9 months
Secondary	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