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
About this trial
This is an interventional screening trial for Peri-Implantitis focused on measuring biomarkers, Calprotectin, Cross-linked N-telopeptides
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.
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
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
Learn more about this trial
Assessment of Efficacy of Calprotectin and Cross-linked N-telopeptides
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