Peri-ImplantitisNCT04177732
Assessment of Efficacy of Calprotectin and Cross-linked N-telopeptides
A study testing Collection of sulcular (crevicular) fluid, Probing depth and Bleeding on probing in people with Peri-Implantitis and Dental Implant Failed, run by Mansour Assery.
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. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis, Dental Implant Failed
- What is being tested?
- Collection of sulcular (crevicular) fluid, Probing depth and Bleeding on probing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2019to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Patients with history of any systemic illness, metabolic disease.
- Patients with history of antibiotic therapy in past ninety days.
About this study
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
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.
Read the 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
- Conditions
- Peri-Implantitis, Dental Implant Failed
- Being tested
- Collection of sulcular (crevicular) fluid, Probing depth, Bleeding on probing, Gingival index, Bone loss rate of alveolar bone
- Keywords
- biomarkers, Calprotectin, Cross-linked N-telopeptides
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of sulcular (crevicular) fluidDiagnostic test
Sterile paper strips will be used for collecting crevicular fluid
Probing depthDiagnostic test
Williams SE manual probe will be used to measure the probing depth
Bleeding on probingDiagnostic test
Williams SE manual probe will be used to probe the sulcus a oserve the gingival reaction
Gingival indexDiagnostic test
Modified Löe and Silness criteria will be used for evaluating the gingival index score
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy peri-implant status | Other | Patient with healthy peri-implant status Receives: 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 |
| Presence of peri-implant diseases | Other | Patients with presence of peri-implant diseases Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calprotectin concentration in GCF
One of inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with bone inflammation
Measured: 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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start10 Dec 2019 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Group A: Healthy peri-implant status Group B: Presence of peri-implant diseases
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansour Assery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mansour Assery, Riyadh Elm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177732
- Sponsor's protocol ID
- Calprotectin-N-telopeptides
- Status last verified
- Nov 2019
- First submitted
- 22 Nov 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04177732
- Acronym / sponsor ID
- Calprotectin-N-telopeptides
- Conditions
- Peri-Implantitis, Dental Implant Failed
- Keywords
- biomarkers, Calprotectin, Cross-linked N-telopeptides
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mansour AsseryUniversity, hospital or other
- Study start
- 10 Dec 2019 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A: Healthy peri-implant status Group B: Presence of peri-implant diseases
| Arm | Type | Receives |
|---|---|---|
| Healthy peri-implant status | Other | 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 bonePatient with healthy peri-implant status |
| Presence of peri-implant diseases | Other | 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 bonePatients with presence of peri-implant diseases |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Patients with history of any systemic illness, metabolic disease.
- Patients with history of antibiotic therapy in past ninety days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of sulcular (crevicular) fluidSterile paper strips will be used for collecting crevicular fluid | Diagnostic test | Healthy peri-implant status, Presence of peri-implant diseases |
| Probing depthWilliams SE manual probe will be used to measure the probing depth | Diagnostic test | Healthy peri-implant status, Presence of peri-implant diseases |
| Bleeding on probingWilliams SE manual probe will be used to probe the sulcus a oserve the gingival reaction | Diagnostic test | Healthy peri-implant status, Presence of peri-implant diseases |
| Gingival indexModified Löe and Silness criteria will be used for evaluating the gingival index score | Diagnostic test | Healthy peri-implant status, Presence of peri-implant diseases |
| Bone loss rate of alveolar boneUsing modification of criteria described by Schei et al, bone loss rate of alveolar bone will be analyzed on radiographic assessment | Diagnostic test | Healthy peri-implant status, Presence of peri-implant diseases |
Primary outcome
Calprotectin concentration in GCF
Time frame: 3 weeks
One of inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with bone inflammation
Cross-linked N-telopeptides concentration in GCF
Time frame: 3 weeks
One of inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with bone inflammation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of sulcular (crevicular) fluid, Probing depth and Bleeding on probing in people with Peri-Implantitis and Dental Implant Failed, run by Mansour Assery.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calprotectin concentration in GCF (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.