Status:

COMPLETED

Maxillary Anterior Immediate Tooth Replacement With and Without Socket-shield

Lead Sponsor:

Loma Linda University

Collaborating Sponsors:

Nobel Biocare

Conditions:

Anterior Teeth

Eligibility:

All Genders

21+ years

Phase:

NA

Brief Summary

The purpose of this clinical controlled study is to compare anterior facial gingival level change between Immediate implant placement and provisionalization with bone graft and with socket shield tech...

Detailed Description

Immediate implant placement and provisionalization, short for IIPP, is one of a very viable option for failing anterior teeth. It has been advocated with documented success for more than 20 years. Des...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Patients must be 21 years of age or older and able to consent to treatment.
  • Good oral hygiene. Patient's oral hygiene should be control to a certain level before start the procedure: Plaque Index (PI) score19 ≤20% and Papillary Bleeding Index (PBI) score20 of less than 5%
  • Have a single failing maxillary anterior tooth with periodontally healthy adjacent teeth.
  • No active infection associated with the failing tooth
  • An extraction socket that will allow a facial implant-socket space of ≥2mm after placement of an implant with a minimum dimensions of 3.0 mm diameter and 13.0 mm in length.
  • Presence of opposing dentition (natural teeth, fixed or removable prostheses)
  • Exclusion Criteria (control group)
  • Systemic disease and/or associated medications that could interfere with implant therapy.
  • Dental history of bruxism, parafunction habit, and/or lack of stable posterior occlusion.
  • Smoker.
  • History of head and neck radiation.
  • Pregnant patient, intending to conceive or breast feeding.
  • Soft tissue defect (inflammation, tissue cleft, recession, papilla loss, unhealthy tissue) around a future implant site.
  • Exclusion Criteria (test group)
  • Systemic disease and/or associated medications that could interfere with implant therapy.
  • Dental history of bruxism, parafunction habit, and/or lack of stable posterior occlusion.
  • Smoker.
  • History of head and neck radiation.
  • Pregnant patient, intending to conceive or breast feeding.
  • Soft tissue defect (inflammation, tissue cleft, recession, papilla loss, unhealthy tissue) around a future implant site.
  • Teeth with active infection like periodontal disease, periapical lesions.
  • Teeth with vertical root fractures on the buccal aspect, horizontal fracture at or below buccal bone level.
  • Teeth with any other pathologies affecting the buccal part of the root, like external or internal resorptions.
  • History of head and neck radiation.
  • Any mobility of the extraction tooth.

Exclusion

    Key Trial Info

    Start Date :

    August 30 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 29 2023

    Estimated Enrollment :

    25 Patients enrolled

    Trial Details

    Trial ID

    NCT04060784

    Start Date

    August 30 2019

    End Date

    March 29 2023

    Last Update

    November 20 2024

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Loma Linda University school of dentistry

    Loma Linda, California, United States, 92350

    2

    Loma Linda University Health

    Loma Linda, California, United States, 92354