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Clinical Performance and Stability of Different Types of Implant Supported Overdenture

Sponsor
National Research Centre, Egypt (Other)
Overall Status
Completed
CT.gov ID
NCT05972538
Collaborator
(none)
6
Enrollment
1
Location
2
Arms
3.1
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A Total number of 36 implants were installed in 6 patients having mandibular single denture.

The patients were divided into two groups according to the definitive prosthesis.

Group I received ball and socket retained mandibular implant overdenture while Group II received cement retained implant supported fixed bridges.

Condition or Disease Intervention/Treatment Phase
  • Device: Osstell ( Osstell AB, Goteborg, Sweden).
  • Device: periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein
  • Other: questionnaire for patient satisfaction
 N/A

Detailed Description

Implant's stability, clinical performance (gingival index, pocket depth, plaque index and bleeding on probing) and patient's satisfaction were performed after 15, 30,60 and 90 days after prosthesis delivery

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
two groups.Group I received ball and socket retained mandibular implant overdenture while Group II received cement retained implant supported fixed bridgestwo groups.Group I received ball and socket retained mandibular implant overdenture while Group II received cement retained implant supported fixed bridges
Masking:
Single (Participant)
Masking Description:
participants don't know which treatment type they received.
Primary Purpose:
Treatment
Official Title:
Clinical Performance and Stability of Different Types of Implant Supported Overdenture
Actual Study Start Date :
Apr 1, 2023
Actual Primary Completion Date :
Jul 1, 2023
Actual Study Completion Date :
Jul 5, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group I

patients received ball and socket retained mandibular implant overdentures restoring complete edentulous mandible.

Device: Osstell ( Osstell AB, Goteborg, Sweden).
Implant stability were assessed on 15, 30,60 and 90 days of prosthesis delivery

Device: periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein
Clinical evaluation included assessment of pocket depth, plaque index and bleeding on probing) around the implant abutments on 15, 30,60 and 90 days of prosthesis delivery
Other Names:
  • - Assessment of implants clinical performance

    • Other: questionnaire for patient satisfaction
    A questionnaire was used to evaluate patient satisfaction on 90 days at the end of follow up period.
    Experimental: Group II

    patients received cement retained mandibular implant overdentures restoring complete edentulous mandible.

    Device: Osstell ( Osstell AB, Goteborg, Sweden).
    Implant stability were assessed on 15, 30,60 and 90 days of prosthesis delivery

    Device: periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein
    Clinical evaluation included assessment of pocket depth, plaque index and bleeding on probing) around the implant abutments on 15, 30,60 and 90 days of prosthesis delivery
    Other Names:
  • - Assessment of implants clinical performance

    • Other: questionnaire for patient satisfaction
    A questionnaire was used to evaluate patient satisfaction on 90 days at the end of follow up period.

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of change in implant stability [on the 15th, 30th, 60th and 90th days of overdenture insertion]

      Assessment of implant stability by device ( Ostell device)

    2. Assessment of change in implants clinical performance throughout the follow-up period. [on the 15th, 30th, 60th and 90th days of over denture insertion.]

      Assessment of change in pocket depth, plaque index and bleeding on probing) around the implant abutments. by periodontal probe.

    Secondary Outcome Measures

    1. Assessment of patient satisfaction [on the 90th day of prosthesis delivery]

      A questionnaire was used to evaluate patient satisfaction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 60 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • highly co-operative

    • non-smoker

    • systemically free from any chronic diseases

    Exclusion Criteria:

    • immunocompromised patients

    • patients having knife edge, flat or flabby ridge,

    • patients having T. M. J disorders

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Research Centre Cairo Dokki Egypt 12622

    Sponsors and Collaborators

    • National Research Centre, Egypt

    Investigators

    • Principal Investigator: Asmaa N. Elboraey, Asso, Prof, National Research Centre, Egypt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Asmaa Nabil Elboraey, Associate Professor, National Research Centre, Egypt
    ClinicalTrials.gov Identifier:
    NCT05972538
    Other Study ID Numbers:
    • 64312012023
    First Posted:
    Aug 2, 2023
    Last Update Posted:
    Aug 2, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Asmaa Nabil Elboraey, Associate Professor, National Research Centre, Egypt
    Implant stability
    Pocket depth
    Patient Satisfaction
    Overdentures

    Study Results

    No Results Posted as of Aug 2, 2023