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

Primary Purpose

Dental Trauma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Functional splinting time
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Trauma focused on measuring luxation injury, splinting time, crown-root fracture, surgical extrusion

Eligibility Criteria

7 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    (Functional splinting time)

    (IADT splinting time)

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Tooth mobility
    Tooth mobility will be assessed using Periotest the measurement unite is discrete range (-8 to 50)
    Tooth mobility
    Tooth mobility will be assessed using Periotest the measurement unite is discrete range (-8 to 50)
    Tooth mobility
    Tooth mobility will be assessed using Periotest the measurement unite is discrete range (-8 to 50)

    Secondary Outcome Measures

    Root resorption
    Root resorption will be assessed using digital radiography the outcome will be binary outcome (Present or Absent) using DIGORA software.
    marginal bone resorption
    marginal bone resorption will be assessed using digital radiography the outcome will be binary outcome (Present or Absent) using DIGORA software.

    Full Information

    First Posted
    October 4, 2018
    Last Updated
    October 6, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03700866
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2016 (Actual)
    Primary Completion Date
    January 30, 2019 (Anticipated)
    Study Completion Date
    January 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Trauma
    Keywords
    luxation injury, splinting time, crown-root fracture, surgical extrusion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    (Functional splinting time)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    (IADT splinting time)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Functional splinting time
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Tooth mobility
    Description
    Tooth mobility will be assessed using Periotest the measurement unite is discrete range (-8 to 50)
    Time Frame
    3 months
    Title
    Tooth mobility
    Description
    Tooth mobility will be assessed using Periotest the measurement unite is discrete range (-8 to 50)
    Time Frame
    6 months
    Title
    Tooth mobility
    Description
    Tooth mobility will be assessed using Periotest the measurement unite is discrete range (-8 to 50)
    Time Frame
    9 months
    Secondary Outcome Measure Information:
    Title
    Root resorption
    Description
    Root resorption will be assessed using digital radiography the outcome will be binary outcome (Present or Absent) using DIGORA software.
    Time Frame
    9 months
    Title
    marginal bone resorption
    Description
    marginal bone resorption will be assessed using digital radiography the outcome will be binary outcome (Present or Absent) using DIGORA software.
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

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

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