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

Status Not yet recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04177732
Study type	Interventional
Source	Riyadh Elm University
Contact
Status	Not yet recruiting
Phase	N/A
Start date	December 10, 2019
Completion date	April 1, 2020

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms