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Soft Tissue Outcomes Of Badly Broken-Down Teeth Treated With Orthodontic Extrusion Compared With Immediate Implant Placement

Primary Purpose

Broken Teeth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Orthodontic extrusion
Immediate implant placement
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Broken Teeth

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients at 20-40 years old and have no history of periodontal disease. (periodontally healthy patients).
  • Single rooted teeth with adjacent intact or restored neighboring teeth, more than one tooth may be included in the same arch.
  • More than 1:1 crown root ratio, so that the C/R is 1:1 after extrusion and restoration.
  • Presence of intact adjacent teeth.

Exclusion Criteria:

  • Badly broken-down teeth with active signs of infection.
  • Teeth with vertical root fracture.
  • Teeth with severely tapered roots..
  • Diabetic patients, assessed by measuring glycosylated hemoglobin (HbA1c). Patients with an HbA1c level greater than 8 will be excluded.
  • Potentially uncooperative patients who are not willing to go through the proposed interventions (patients who will refuse to undergo orthodontic treatment).
  • Moderate-to-heavy daily smokers* (who report consuming at least 11 cigarettes/day).
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems, emotional instability, and unrealistic esthetic demands.
  • History of radiation therapy to the head and neck, or bone augmentation to implant site.
  • Labial cortical bone fenestration diagnosed from CBCT.
  • Bruxism.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Orthodontic extrusion

    Immediate implant placement

    Arm Description

    An orthodontic attachment will be bonded to the core of the experimental tooth. Orthodontic brackets "American Orthodontics Roth prescription. 0.022" slot" will be bonded to the adjacent teeth. A passive rectangular stainless steel wire (0.016X0.022") will be inserted in the adjacent teeth with a step down and a coil at the site of the experimental tooth. Orthodontic extrusion will start using a light overlay wire of 0.012" NiTi and then continued by elastic chains/ threads extending between the attachment on the tooth and the stabilizing wire. The patient is followed up for appliance activation every 3-4 weeks and extrusion is performed until an adequate ferrule effect of 2 mm is present all around the tooth circumference (in addition to the biologic width). So the extrusion is completed when the tooth is 4-4.5 mm from the alveolar bone crest as judged by periapical radiographs.

    The patient is anaesthetized. Atraumatic extraction of the badly broken down teeth will be performed using peroiotome. Luxation should be done mesiodistally and not buccolingually, to avoid damaging the buccal plate. After tooth removal, a curette is used to confirm that the location of the buccal plate is intact. Standard drilling procedures are performed according to the manufacturer's instructions. Then the implant is placed in the prepared site. Temporization should be done using composite 3M Filtek Z250 XT material. Finally, a porcelain fused to zirconia crown will be performed.

    Outcomes

    Primary Outcome Measures

    Soft tissue outcome
    Pink esthetic score: 0-1-2 scoring system, 0 being the lowest, 2 being the highest value

    Secondary Outcome Measures

    Survival
    Tooth and Implant survival

    Full Information

    First Posted
    June 15, 2020
    Last Updated
    June 16, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04436094
    Brief Title
    Soft Tissue Outcomes Of Badly Broken-Down Teeth Treated With Orthodontic Extrusion Compared With Immediate Implant Placement
    Official Title
    Soft Tissue Outcomes Of Badly Broken-Down Teeth Treated With Orthodontic Extrusion Compared With Immediate Implant Placement: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2020 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    September 2021 (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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Many patients suffer from tooth substance loss as a result of fracture or decay of teeth situated in the esthetic zone. This might commonly occur with car accidents, sport injuries, falls or even fistfights. For those patients, most of the crown is lost and only the root remains, so there is no enough ferrule in order to restore the tooth with a crown. The most common treatment for those patients is immediate single-tooth implant. However, some problems may arise such as: high treatment expenses, the need for bone augmentation, the refill of the papilla to its normal position may be questionable in some implant cases, young growing patients, apprehensive patients, dental facilities and rural areas lacking cone beam computed tomography (CBCT) machines. Accordingly, orthodontic extrusion may be an alternative attempt to preserve the tooth by traction of the remaining root to create a sufficient ferrule effect to restore the tooth.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Broken Teeth

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Orthodontic extrusion
    Arm Type
    Experimental
    Arm Description
    An orthodontic attachment will be bonded to the core of the experimental tooth. Orthodontic brackets "American Orthodontics Roth prescription. 0.022" slot" will be bonded to the adjacent teeth. A passive rectangular stainless steel wire (0.016X0.022") will be inserted in the adjacent teeth with a step down and a coil at the site of the experimental tooth. Orthodontic extrusion will start using a light overlay wire of 0.012" NiTi and then continued by elastic chains/ threads extending between the attachment on the tooth and the stabilizing wire. The patient is followed up for appliance activation every 3-4 weeks and extrusion is performed until an adequate ferrule effect of 2 mm is present all around the tooth circumference (in addition to the biologic width). So the extrusion is completed when the tooth is 4-4.5 mm from the alveolar bone crest as judged by periapical radiographs.
    Arm Title
    Immediate implant placement
    Arm Type
    Active Comparator
    Arm Description
    The patient is anaesthetized. Atraumatic extraction of the badly broken down teeth will be performed using peroiotome. Luxation should be done mesiodistally and not buccolingually, to avoid damaging the buccal plate. After tooth removal, a curette is used to confirm that the location of the buccal plate is intact. Standard drilling procedures are performed according to the manufacturer's instructions. Then the implant is placed in the prepared site. Temporization should be done using composite 3M Filtek Z250 XT material. Finally, a porcelain fused to zirconia crown will be performed.
    Intervention Type
    Procedure
    Intervention Name(s)
    Orthodontic extrusion
    Intervention Description
    An orthodontic attachment will be bonded to the core of the experimental tooth. Orthodontic brackets "American Orthodontics Roth prescription. 0.022" slot" will be bonded to the adjacent teeth. A passive rectangular stainless steel wire (0.016X0.022") will be inserted in the adjacent teeth with a step down and a coil at the site of the experimental tooth. Orthodontic extrusion will start using a light overlay wire of 0.012" NiTi and then continued by elastic chains/ threads extending between the attachment on the tooth and the stabilizing wire. The patient is followed up for appliance activation every 3-4 weeks and extrusion is performed until an adequate ferrule effect of 2 mm is present all around the tooth circumference (in addition to the biologic width). So the extrusion is completed when the tooth is 4-4.5 mm from the alveolar bone crest as judged by periapical radiographs.
    Intervention Type
    Procedure
    Intervention Name(s)
    Immediate implant placement
    Intervention Description
    The patient is anaesthetized. Atraumatic extraction of the badly broken down teeth will be performed using peroiotome. Luxation should be done mesiodistally and not buccolingually, to avoid damaging the buccal plate. After tooth removal, a curette is used to confirm that the location of the buccal plate is intact. Standard drilling procedures are performed according to the manufacturer's instructions. Then the implant is placed in the prepared site. Temporization should be done using composite 3M Filtek Z250 XT material. Finally, a porcelain fused to zirconia crown will be performed.
    Primary Outcome Measure Information:
    Title
    Soft tissue outcome
    Description
    Pink esthetic score: 0-1-2 scoring system, 0 being the lowest, 2 being the highest value
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Survival
    Description
    Tooth and Implant survival
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients at 20-40 years old and have no history of periodontal disease. (periodontally healthy patients). Single rooted teeth with adjacent intact or restored neighboring teeth, more than one tooth may be included in the same arch. More than 1:1 crown root ratio, so that the C/R is 1:1 after extrusion and restoration. Presence of intact adjacent teeth. Exclusion Criteria: Badly broken-down teeth with active signs of infection. Teeth with vertical root fracture. Teeth with severely tapered roots.. Diabetic patients, assessed by measuring glycosylated hemoglobin (HbA1c). Patients with an HbA1c level greater than 8 will be excluded. Potentially uncooperative patients who are not willing to go through the proposed interventions (patients who will refuse to undergo orthodontic treatment). Moderate-to-heavy daily smokers* (who report consuming at least 11 cigarettes/day). Patients with systemic disease that may affect normal healing. Psychiatric problems, emotional instability, and unrealistic esthetic demands. History of radiation therapy to the head and neck, or bone augmentation to implant site. Labial cortical bone fenestration diagnosed from CBCT. Bruxism.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Moustafa O Shehata, B.D.S.
    Phone
    00201225897482
    Email
    moustafa.hassan@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ismail T Mansour, B.D.S.
    Phone
    00201003361428
    Email
    ismail.mansour@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Moustafa O Shehata, B.D.S.
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
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    Soft Tissue Outcomes Of Badly Broken-Down Teeth Treated With Orthodontic Extrusion Compared With Immediate Implant Placement

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