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Change in Gingival Volume and Quality of Life Due to Initial Periodontal Therapy in Smokers

Primary Purpose

Periodontitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Initial periodontal therapy and 3D intraoral scanning
Sponsored by
University of Rijeka
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Periodontitis focused on measuring 3D imaging, gingiva, nonsurgical periodontal debridement, periodontitis, quality of life, smoking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: periodontitis cigarette smokers non smokers Exclusion Criteria: previous periodontal treatment pregnancy minors antibiotic therapy in the last 6 months patients with ortho appliances patients using drugs that affect gingival volume immunosuppressive therapy systemic conditions that affects periodontal tissues and therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Smokers

    Non smokers

    Arm Description

    Outcomes

    Primary Outcome Measures

    Volume changes
    soft tissue volume changes after therapy ( mm3)

    Secondary Outcome Measures

    Full Information

    First Posted
    January 25, 2023
    Last Updated
    February 7, 2023
    Sponsor
    University of Rijeka
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05719519
    Brief Title
    Change in Gingival Volume and Quality of Life Due to Initial Periodontal Therapy in Smokers
    Official Title
    Change in Gingival Volume and Quality of Life Due to Initial Periodontal Therapy in Smokers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    The aim of this study is to compare the dimensional changes of the gingiva due to initial periodontal therapy in non-smokers and cigarette smokers and to compare the oral health related quality of life of non-smokers and cigarette smokers with periodontitis before and after initial periodontal therapy. Changes in gingival volume are expected to be greater in non-smokers than in cigarette smokers. It is expected that the quality of life will be better after therapy in both groups, with better results in the non-smoking group. 60 subjects with periodontitis will be included in the study 30 non-smokers and 30 cigarette smokers. All subjects will fill out a quality of life questionnaire which will be validated before the onset of this research. This will be followed by clinical periodontal examination. After examination, the upper and lower jaw will be scanned using an intraoral scanner and initial periodontal therapy will be performed. After 8 weeks, subjects will fill out the quality of life questionnaire again, measurement of periodontal indices and scanning will be performed. The digital scans wll be superimposed, and the dimensional changes of the gingiva will be quantified and compared between the two groups. By using 3D technology, it will be possible to objectively quantify tissue changes and monitor the course of the disease. A 3D comparison between non-smokers and cigarette smokers will provide a new perspective on the relationship between smoking and periodontitis. Furthermore, it will be demonstrated to what extent smoking affects the quality of life of patients with periodontitis and the results of non-surgical therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis
    Keywords
    3D imaging, gingiva, nonsurgical periodontal debridement, periodontitis, quality of life, smoking

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Smokers
    Arm Type
    Other
    Arm Title
    Non smokers
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Initial periodontal therapy and 3D intraoral scanning
    Intervention Description
    Initial periodontal therapy using GBT ( guided biofilm therapy) principle and 3D intraoral scanning
    Primary Outcome Measure Information:
    Title
    Volume changes
    Description
    soft tissue volume changes after therapy ( mm3)
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: periodontitis cigarette smokers non smokers Exclusion Criteria: previous periodontal treatment pregnancy minors antibiotic therapy in the last 6 months patients with ortho appliances patients using drugs that affect gingival volume immunosuppressive therapy systemic conditions that affects periodontal tissues and therapy

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Change in Gingival Volume and Quality of Life Due to Initial Periodontal Therapy in Smokers

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