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Post Extraction Wound Healing Evaluation of Immediate Complete Denture Using IPR Scale

Primary Purpose

Complete Edentulism Due to Periodontal Disease (Disorder)

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CEO Pack
Sponsored by
Badr University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complete Edentulism Due to Periodontal Disease (Disorder)

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Good physical and mental health
  • Willing to give informed consent
  • Normal maxilla-mandibular relationship Angle Class I
  • Adequate bone quality and quantity in terms of width and height in the anterior maxillary and mandibular ridges verified by preoperative cone beam CT
  • Adequate inter-arch space to accommodate maxillary and mandibular implant prostheses

Exclusion Criteria:

  • Uncontrolled diabetes
  • Smoking habits
  • Radiotherapy
  • Clinical or radiographic signs of pathologic conditions, osteoporosis
  • Patients on corticosteroids
  • Bruxism

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Conventional upper immediate denture

    Upper immediate denture lined by surgical dressing

    Arm Description

    Conventional upper immediate denture without any surgical lining

    Upper immediate denture lined by surgical dressing using CEO Pack dressing

    Outcomes

    Primary Outcome Measures

    Post extraction Assessment
    Post extraction Assessment of Wound Healing following Inflammatory Proliferative Remodeling (IPR) scale. The scale is divided into three subscales corresponding to the three phases of wound healing, and each is rated at the appropriate time point during follow-up,3 yielding three subscale scores and a total score. The outcome parameters of the subscales depend on the biological events that occur during that specific phase. At the end of follow up, the total score of the IPR Scale was calculated (0-16), where 0-4 indicated poor healing, 5-10 acceptable healing, and 11-16 excellent healing

    Secondary Outcome Measures

    Full Information

    First Posted
    July 15, 2022
    Last Updated
    July 20, 2022
    Sponsor
    Badr University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05464914
    Brief Title
    Post Extraction Wound Healing Evaluation of Immediate Complete Denture Using IPR Scale
    Official Title
    Post Extraction Wound Healing Evaluation of Immediate Complete Denture Using IPR Scale
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    February 1, 2023 (Anticipated)
    Study Completion Date
    April 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    In the first part, after a brief introduction, the advantages and disadvantages of immediate dentures are compared. There is a detailed discussion on assessment and treatment planning which includes history taking, examination of the soft and hard tissues, current prostheses, occlusion as well as discussion on investigations required and formulating a diagnosis. The first part ends with a summary of types of immediate dentures and denture designs.
    Detailed Description
    An Immediate denture is a complete or partial removable prosthesis that is fitted immediately after extraction or modification of teeth. The prosthesis replaces the missing/modified teeth and where required, the adjacent hard and soft tissues. It is constructed prior to the extraction of teeth and is used immediately to provide function and aesthetics which are lost as a result of tooth removal and avoid the embarrassment patients may have with living without teeth, while waiting for the tissues to heal prior to definitive tooth replacement.1 (See image 1) Some clinicians take impressions on the day of the extractions and fit the dentures a few days later. These dentures are fraught with challenges as the alveolar ridge begins to resorb soon after. Therefore an immediate denture is only truly an immediate denture when fitted on the day of the extractions. The use of a removable prosthesis within the UK is currently around 19% of adults in the general population 2 and in spite of this decreasing trend, as patients retain their natural dentition into older age,2 there is still a need for prosthodontic replacement as teeth are lost as a result of caries, periodontal disease, tooth wear or trauma. 3,4,5 The provision of an immediate denture can be challenging and close co-operation between patient, technician, and clinician is required.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Complete Edentulism Due to Periodontal Disease (Disorder)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional upper immediate denture
    Arm Type
    No Intervention
    Arm Description
    Conventional upper immediate denture without any surgical lining
    Arm Title
    Upper immediate denture lined by surgical dressing
    Arm Type
    Active Comparator
    Arm Description
    Upper immediate denture lined by surgical dressing using CEO Pack dressing
    Intervention Type
    Drug
    Intervention Name(s)
    CEO Pack
    Other Intervention Name(s)
    Perio pak, Surgical pak
    Intervention Description
    is a eugenol-free, surgical dressing and periodontal pack that has no burning sensation, no unpleasant taste or odor, and offers proven protection to surgical sites. This product promotes cleanliness and healing. Plastic and cohesive, ropes of any length or thickness can be formed. The smooth texture allows this product to adapt closely to the teeth and tissue in order to protect the wound. It sets with resilient, non-brittle hardness.
    Primary Outcome Measure Information:
    Title
    Post extraction Assessment
    Description
    Post extraction Assessment of Wound Healing following Inflammatory Proliferative Remodeling (IPR) scale. The scale is divided into three subscales corresponding to the three phases of wound healing, and each is rated at the appropriate time point during follow-up,3 yielding three subscale scores and a total score. The outcome parameters of the subscales depend on the biological events that occur during that specific phase. At the end of follow up, the total score of the IPR Scale was calculated (0-16), where 0-4 indicated poor healing, 5-10 acceptable healing, and 11-16 excellent healing
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Good physical and mental health Willing to give informed consent Normal maxilla-mandibular relationship Angle Class I Adequate bone quality and quantity in terms of width and height in the anterior maxillary and mandibular ridges verified by preoperative cone beam CT Adequate inter-arch space to accommodate maxillary and mandibular implant prostheses Exclusion Criteria: Uncontrolled diabetes Smoking habits Radiotherapy Clinical or radiographic signs of pathologic conditions, osteoporosis Patients on corticosteroids Bruxism
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shady M. El Naggar, PhD
    Phone
    01122110085
    Email
    shady.mahmoud@buc.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shady M. El Naggar, PhD
    Organizational Affiliation
    Badr University in Cairo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Post Extraction Wound Healing Evaluation of Immediate Complete Denture Using IPR Scale

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