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Investigate New Surgical Techniques to Improve Esthetics and Patient Satisfaction at Implant Sites

Primary Purpose

Fractured Tooth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
socket shield technique with xenophobic graft particulate and without the use of graft
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fractured Tooth

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with non-restorable maxillary anterior teeth in the esthetic zone indicated for implant placement.
  • Both sexes.
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placement

Exclusion Criteria:

  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.
  • Uncontrolled diabetic patients.
  • Pregnant patients.
  • Teeth with Large pulpal pathosis as cysts, large periapical granulomas
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
  • Immunodeficiency pathology, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
  • Psychiatric problems.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    grafted versus graft less socket shield technique

    Arm Description

    Outcomes

    Primary Outcome Measures

    Marginal bone loss
    Will be measured using linear measurements from CBCT

    Secondary Outcome Measures

    secondary stability
    Will be measured using Osstell

    Full Information

    First Posted
    September 22, 2019
    Last Updated
    September 23, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04101552
    Brief Title
    Investigate New Surgical Techniques to Improve Esthetics and Patient Satisfaction at Implant Sites
    Official Title
    Clinical and Radiographic Assessment of Immediate Implant Placement in Maxillary Esthetic Zone Using Socket Shield Technique With and Without the Use of Xenograft Particulate Graft Material
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 20, 2019 (Anticipated)
    Primary Completion Date
    February 20, 2020 (Anticipated)
    Study Completion Date
    August 20, 2020 (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 techniques have been proposed to prevent or rather minimize the labial bone resorption following extraction including guided bone regeneration techniques that has been attempted for many years now to preserve the alveolar ridge dimensions . Immediate implant placement, flapless implant placement, palataly positioned implants and even platform switching. However none of these methods were able to completely preserve the coronal part of the facial bone wall, and since the main reason of bone loss following extraction is the loss of the periodontal ligament, it seemed logical that root retention may affect the resorption process,The reason the root retention technique works in its different applications is due to the maintenance of the periodontal attachment including cementum, periodontal ligaments and bundle bone, this principle was used by Hurzeler in 2010 in a technique called socket shied technique.
    Detailed Description
    The selected patients will be informed of the nature of the research work and informed consent will be obtained then randomized in equal proportions between control group conventional immediate implant placement with immediate temporization and study group socket shield technique with immediate temporization. Patients of both groups will be subjected to CBCT (diagnostic for upper arch). Intra operative procedures (for both groups) followed by CBCT will be taken for every patient Infiltration local anesthesia will be given to the patient (Articaine 4% 1:100 000 epinephrine) Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures. In the study group: along surgical fissure bur will be used for hemisectioning. The palatal portion will be carefully separated and extracted by a periotome and forceps. The osteomy site will be inspected and cleaned from any granulation tissue and the implant will be placed palatal to the tooth fragment. The jump gap was grafted with a xenogeneic bone particulate (De-proteinized bovine bone mineral Small granules (0.25-1 mm), the implant gained primary stability from bone apical and palatal sufficient to immediately restore with provisional restoration. In the control group: the root was hemisected using a fissure bur in a mesio-distal direction, and a traumatic removal of the palatal fragment of the root was achieved (no pressure was applied on it), then the buccal fragment was reduced using surgical bur leaving a thin layer of the root aspect intact to the buccal plate of the bone. The implant is placed in the socket in a way leaving space away from the remaining buccal plate without grafting this jumping gap The provisional restorations were relieved of occlusal contacts in centric occlusion and excursive movements. These restorations remained in situ for at least 6 to 12 weeks prior to any modifications or commencement of definitive restorative therapy A soft diet was recommended for the duration of the implant-healing phase. The patient was advised against functioning or activities to the implant site.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fractured Tooth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    grafted versus graft less socket shield technique
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    socket shield technique with xenophobic graft particulate and without the use of graft
    Intervention Description
    the jumping gap between the implant and the shield is grafted by xenograft particulate and the control group is not grafted
    Primary Outcome Measure Information:
    Title
    Marginal bone loss
    Description
    Will be measured using linear measurements from CBCT
    Time Frame
    • Amount of bone loss will be measured after 6 month using linear measurement from CBCT
    Secondary Outcome Measure Information:
    Title
    secondary stability
    Description
    Will be measured using Osstell
    Time Frame
    will be measured intraoperative and 3 months after surgery
    Other Pre-specified Outcome Measures:
    Title
    pink esthetic score
    Description
    Will be measured using pink esthetic index chart
    Time Frame
    Pink esthetics will be measured using pink esthetic index chart After 6 months.

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with non-restorable maxillary anterior teeth in the esthetic zone indicated for implant placement. Both sexes. No intraoral soft and hard tissue pathology No systemic condition that contraindicate implant placement Exclusion Criteria: Heavy smokers more than 20 cigarettes per day. Patients with systemic disease that may affect normal healing. Uncontrolled diabetic patients. Pregnant patients. Teeth with Large pulpal pathosis as cysts, large periapical granulomas Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site. Immunodeficiency pathology, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands. Psychiatric problems.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Poosy H. Mohamed, principal investigator
    Phone
    01098008064
    Ext
    00202
    Email
    pussy_hany@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed A. Abdelrasoul, lecturer

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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