NCT04177732

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

December 10, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

December 2, 2019

Status Verified

November 1, 2019

Enrollment Period

2 months

First QC Date

November 22, 2019

Last Update Submit

November 27, 2019

Conditions

Peri-ImplantitisDental Implant Failed

Keywords

biomarkersCalprotectinCross-linked N-telopeptides

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Healthy peri-implant status

OTHER

Patient with healthy peri-implant status

Diagnostic Test: Collection of sulcular (crevicular) fluidDiagnostic Test: Probing depthDiagnostic Test: Bleeding on probingDiagnostic Test: Gingival indexDiagnostic Test: Bone loss rate of alveolar bone

Presence of peri-implant diseases

OTHER

Patients with presence of peri-implant diseases

Diagnostic Test: Collection of sulcular (crevicular) fluidDiagnostic Test: Probing depthDiagnostic Test: Bleeding on probingDiagnostic Test: Gingival indexDiagnostic Test: Bone loss rate of alveolar bone

Interventions

Collection of sulcular (crevicular) fluidDIAGNOSTIC_TEST

Sterile paper strips will be used for collecting crevicular fluid

Healthy peri-implant statusPresence of peri-implant diseases
Probing depthDIAGNOSTIC_TEST

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

Healthy peri-implant statusPresence of peri-implant diseases
Bleeding on probingDIAGNOSTIC_TEST

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

Healthy peri-implant statusPresence of peri-implant diseases
Gingival indexDIAGNOSTIC_TEST

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

Healthy peri-implant statusPresence of peri-implant diseases
Bone loss rate of alveolar boneDIAGNOSTIC_TEST

Using modification of criteria described by Schei et al, bone loss rate of alveolar bone will be analyzed on radiographic assessment

Healthy peri-implant statusPresence of peri-implant diseases

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Group A: Healthy peri-implant status Group B: Presence of peri-implant diseases
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant in Prosthodontics & Dental Implant

Study Record Dates

First Submitted

November 22, 2019

First Posted

November 26, 2019

Study Start

December 10, 2019

Primary Completion

February 1, 2020

Study Completion

April 1, 2020

Last Updated

December 2, 2019

Record last verified: 2019-11