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

Peri-Implantitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04177732
• Other study ID #: Calprotectin-N-telopeptides
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: November 2019
• Source: Riyadh Elm University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: April 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

Exclusion Criteria:

• Patients with history of any systemic illness, metabolic disease.

• Patients with history of antibiotic therapy in past ninety days.

Related Conditions & MeSH terms

• Dental Implant Failed
• Peri-Implantitis

Intervention

Diagnostic Test:
• Collection of sulcular (crevicular) fluid
Sterile paper strips will be used for collecting crevicular fluid
• Probing depth
Williams SE manual probe will be used to measure the probing depth
• Bleeding on probing
Williams SE manual probe will be used to probe the sulcus a oserve the gingival reaction
• Gingival index
Modified Löe and Silness criteria will be used for evaluating the gingival index score
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansour Assery

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calprotectin concentration in GCF	One of inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with bone inflammation	3 weeks
Primary	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