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

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

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.

Study Overview

• Status: Unknown
• Conditions: Peri-Implantitis; Dental Implant Failed
• Intervention / Treatment: Diagnostic test: Collection of sulcular (crevicular) fluid; Diagnostic test: Probing depth; Diagnostic test: Bleeding on probing; Diagnostic test: Gingival index; Diagnostic test: Bone loss rate of alveolar bone

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

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Healthy peri-implant status; Patient with healthy peri-implant status	Diagnostic test: Collection of sulcular (crevicular) fluid; Sterile paper strips will be used for collecting crevicular fluid; Diagnostic test: Probing depth; Williams SE manual probe will be used to measure the probing depth; Diagnostic test: Bleeding on probing; Williams SE manual probe will be used to probe the sulcus a oserve the gingival reaction; Diagnostic test: Gingival index; Modified Löe and Silness criteria will be used for evaluating the gingival index score; Diagnostic test: Bone loss rate of alveolar bone; Using modification of criteria described by Schei et al, bone loss rate of alveolar bone will be analyzed on radiographic assessment
OTHER: Presence of peri-implant diseases; Patients with presence of peri-implant diseases	Diagnostic test: Collection of sulcular (crevicular) fluid; Sterile paper strips will be used for collecting crevicular fluid; Diagnostic test: Probing depth; Williams SE manual probe will be used to measure the probing depth; Diagnostic test: Bleeding on probing; Williams SE manual probe will be used to probe the sulcus a oserve the gingival reaction; Diagnostic test: Gingival index; Modified Löe and Silness criteria will be used for evaluating the gingival index score; Diagnostic test: Bone loss rate of alveolar bone; Using modification of criteria described by Schei et al, bone loss rate of alveolar bone will be analyzed on radiographic assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calprotectin concentration in GCF	One of inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with bone inflammation	3 weeks
Cross-linked N-telopeptides concentration in GCF	One of inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with bone inflammation	3 weeks

Collaborators and Investigators

• Sponsor: Mansour Assery

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 10, 2019
• Primary Completion (ANTICIPATED): February 1, 2020
• Study Completion (ANTICIPATED): April 1, 2020

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (ACTUAL): November 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: biomarkers; Calprotectin; Cross-linked N-telopeptides
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: Calprotectin-N-telopeptides

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No