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

NCT03700866 | Unknown

• 1 other identifier: splinting time
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Trauma

Keywords

luxation injury; splinting time; crown-root fracture; surgical extrusion

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Root resorption

  9 months

• marginal bone resorption

  9 months

Study Arms (2)

(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.

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.

Procedure: Functional splinting time

Interventions

Functional splinting time PROCEDURE

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

(Functional splinting time); (IADT splinting time)

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Pediatric Dentistry and Community Dentistry, Faculty of Dentistry, Cairo University, Egypt

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 9, 2018
• Study Start: October 1, 2016
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: October 9, 2018

Record last verified: 2018-10