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BMP-2 and ALP Levels Following Laser Therapy With Scaling and Root Planing in Periodontitis- RCT.

Primary Purpose

Periodontitis, Laser

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SRP+Laser
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis, Laser

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Periodontitis

Exclusion Criteria:

  • Uncontrolled medical condition

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    SRP only

    SRP+Laser

    Arm Description

    Outcomes

    Primary Outcome Measures

    Amount of attachment gain
    Described in mm

    Secondary Outcome Measures

    Level of BMP-2 in GCF
    ELISA test
    Level of ALP in GCF
    Colorimetry

    Full Information

    First Posted
    September 22, 2022
    Last Updated
    September 22, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05555420
    Brief Title
    BMP-2 and ALP Levels Following Laser Therapy With Scaling and Root Planing in Periodontitis- RCT.
    Official Title
    Assessment of BMP-2 and ALP Levels Following Laser Therapy as an Adjunct to Scaling and Root Planing for Treatment of Periodontitis- A Randomized Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2022 (Anticipated)
    Primary Completion Date
    July 1, 2023 (Anticipated)
    Study Completion Date
    December 1, 2023 (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
    Yes

    5. Study Description

    Brief Summary
    Patients with periodontitis will be treated by either SRP only or SRP in combination with laser. Samples from GCF will be collected immediately after treatment and at 3 months follow-up time. Levels of BMP-2 and ALP will be assessed at these time points. Statistical analysis to compare the results will be performed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis, Laser

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SRP only
    Arm Type
    Active Comparator
    Arm Title
    SRP+Laser
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    SRP+Laser
    Intervention Description
    Non-surgical periodontal therapy in combination with Laser
    Primary Outcome Measure Information:
    Title
    Amount of attachment gain
    Description
    Described in mm
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Level of BMP-2 in GCF
    Description
    ELISA test
    Time Frame
    3 months
    Title
    Level of ALP in GCF
    Description
    Colorimetry
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Periodontitis Exclusion Criteria: Uncontrolled medical condition

    12. IPD Sharing Statement

    Learn more about this trial

    BMP-2 and ALP Levels Following Laser Therapy With Scaling and Root Planing in Periodontitis- RCT.

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