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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04177732
Enrollment
10
Registered
2019-11-26
Start date
2019-12-10
Completion date
2020-04-01
Last updated
2019-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-Implantitis, Dental Implant Failed

Keywords

biomarkers, Calprotectin, Cross-linked N-telopeptides

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

Interventions

DIAGNOSTIC_TESTCollection of sulcular (crevicular) fluid

Sterile paper strips will be used for collecting crevicular fluid

DIAGNOSTIC_TESTProbing depth

Williams SE manual probe will be used to measure the probing depth

DIAGNOSTIC_TESTBleeding on probing

Williams SE manual probe will be used to probe the sulcus a oserve the gingival reaction

DIAGNOSTIC_TESTGingival index

Modified Löe and Silness criteria will be used for evaluating the gingival index score

DIAGNOSTIC_TESTBone 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

Sponsors

Mansour Assery
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Masking description

No masking

Intervention model description

Group A: Healthy peri-implant status Group B: Presence of peri-implant diseases

Eligibility

Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
Yes

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Calprotectin concentration in GCF3 weeksOne of inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with bone inflammation
Cross-linked N-telopeptides concentration in GCF3 weeksOne of inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with bone inflammation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026