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Assessment of Efficacy of Calprotectin and Cross-linked N-telopeptides

Primary Purpose

Peri-Implantitis, Dental Implant Failed

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Collection of sulcular (crevicular) fluid
Probing depth
Bleeding on probing
Gingival index
Bone loss rate of alveolar bone
Sponsored by
Mansour Assery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Peri-Implantitis focused on measuring biomarkers, Calprotectin, Cross-linked N-telopeptides

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Exclusion Criteria:

  • Patients with history of any systemic illness, metabolic disease.
  • Patients with history of antibiotic therapy in past ninety days.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Healthy peri-implant status

    Presence of peri-implant diseases

    Arm Description

    Patient with healthy peri-implant status

    Patients with presence of peri-implant diseases

    Outcomes

    Primary Outcome Measures

    Calprotectin concentration in GCF
    One of inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with bone inflammation
    Cross-linked N-telopeptides concentration in GCF
    One of inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with bone inflammation

    Secondary Outcome Measures

    Full Information

    First Posted
    November 22, 2019
    Last Updated
    November 27, 2019
    Sponsor
    Mansour Assery
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04177732
    Brief Title
    Assessment of Efficacy of Calprotectin and Cross-linked N-telopeptides
    Official Title
    Assessment of Efficacy of Calprotectin and Cross-linked N-telopeptides of Type I Collagen Levels in Crevicular Fluid as a Biomarker in Patients With Peri-implantitis: A Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 10, 2019 (Anticipated)
    Primary Completion Date
    February 1, 2020 (Anticipated)
    Study Completion Date
    April 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mansour Assery

    4. Oversight

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

    5. Study Description

    Brief Summary
    The study aims to assess the efficacy of Calprotectin and cross-linked N-telopeptides of type I collagen levels in crevicular fluid as a biomarker in patients with peri-implantitis.
    Detailed Description
    Ethical approval will be obtained from the ethical committee of the Riyadh Elm University and written consent will be obtained from all the patients after explaining in detail the entire research protocol. Inclusion criteria for the present study: 10 patients who underwent dental implant procedure five to ten years ago; among these- 5 patients will be with healthy peri-implant status and 5 patients with presence of peri-implant diseases Patients of comparable age and gender distribution- Patients within the age group of 25 to 45 years; and 3 males and 2 females in peri-implant diseases group and 3 males and 2 females in healthy peri-implant status group Patients with negative history of any systemic illness, metabolic disease. Patients with negative history of antibiotic therapy in past ninety days. After collecting the PICF and GCF, examination of probing depth (PD), bleeding on probing (BOP) and gingival index (GI) will be done.Modified Löe and Silness criteria will be used for evaluating the GI score.Using modification of criteria described by Schei et al, bone loss rate of alveolar bone will be analyzed on radiographic assessment. Periodontal sites with PD of equal to or more than 3mm with GI score of equal to or more than 1mm and presence or absence of BOP, will be categorized as peri-implant disease sites. Periodontal sites with PD of less than 3mm with GI score of 0 and absence of BOP will be categorized as healthy implant sites. Sterile paper strips will be used for collecting PICF samples, followed by PICF sample preparation using modified criteria described previously in the literature. Isolation of the PICF sampling sites will be done using cotton roles. This will be followed by removal of supra-gingival plaques and gentle air drying. Insertion of the periopaper will be done into the peri-implant crevice and will be kept there for thirty seconds. Periotron will be used for measuring the volume of PICF. Further, all the samples will be sent to laboratory where ELISA technique will be used for measuring the calprotectin

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peri-Implantitis, Dental Implant Failed
    Keywords
    biomarkers, Calprotectin, Cross-linked N-telopeptides

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group A: Healthy peri-implant status Group B: Presence of peri-implant diseases
    Masking
    None (Open Label)
    Masking Description
    No masking
    Allocation
    Non-Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy peri-implant status
    Arm Type
    Other
    Arm Description
    Patient with healthy peri-implant status
    Arm Title
    Presence of peri-implant diseases
    Arm Type
    Other
    Arm Description
    Patients with presence of peri-implant diseases
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Collection of sulcular (crevicular) fluid
    Intervention Description
    Sterile paper strips will be used for collecting crevicular fluid
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Probing depth
    Intervention Description
    Williams SE manual probe will be used to measure the probing depth
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Bleeding on probing
    Intervention Description
    Williams SE manual probe will be used to probe the sulcus a oserve the gingival reaction
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Gingival index
    Intervention Description
    Modified Löe and Silness criteria will be used for evaluating the gingival index score
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Bone loss rate of alveolar bone
    Intervention Description
    Using modification of criteria described by Schei et al, bone loss rate of alveolar bone will be analyzed on radiographic assessment
    Primary Outcome Measure Information:
    Title
    Calprotectin concentration in GCF
    Description
    One of inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with bone inflammation
    Time Frame
    3 weeks
    Title
    Cross-linked N-telopeptides concentration in GCF
    Description
    One of inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with bone inflammation
    Time Frame
    3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Exclusion Criteria: Patients with history of any systemic illness, metabolic disease. Patients with history of antibiotic therapy in past ninety days.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Assessment of Efficacy of Calprotectin and Cross-linked N-telopeptides

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