Chronic PeriodontitisNCT03128502
Estimation of Pentrexin-3 Levels in GCF and Saliva of Patients With Periodontal Disease
An observational study of Chronic Periodontitis and Aggressive Periodontitis, run by Cairo University.
Trial summary
Subjects were selected from the outpatient clinic, Department of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University. Ten healthy control subjects presented with clinically healthy periodontium. Ten patients who had plaque induced gingivitis. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Chronic Periodontitis, Aggressive Periodontitis
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Apr 2017
- Phase
- Observational
- 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 50 years
- All sexes
- Adult
Study population: Patients from the outpatient clinic, Department of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University suffering from diffrent periodontal diseases.
Who may be able to join
- patients with plaque induced gingivitis
- patients with chronic periodontitis
- patients with aggressive periodontitis
Who cannot join
- Patients with any systemic disease according to Cornell medical index (1968).
- Patients taking any medications or antibiotics in the last 3 months.
- Current or former smoker patients.
- Pregnant females.
About this study
Official title: Assessment of Pentraxin-3 Levels in Gingival Crevicular Fluid and Saliva in Periodontal Health and Disease
Subjects were selected from the outpatient clinic, Department of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University. Ten healthy control subjects presented with clinically healthy periodontium. Ten patients who had plaque induced gingivitis. Ten patients who had generalized chronic periodontitis. Ten patients who had generalised aggressive periodontitis. Pentraxin-3 levels were evaluated in GCF and saliva of all subjects included in this study with ELISA technique.
Read the detailed description
The study population consisted of 4 groups of forty patients selected as follows:
Group 1 - Healthy Controls:
Ten healthy control subjects presented with clinically healthy periodontium. Control subjects had to meet the following criteria for inclusion: probing depth less than 3mm, no clinical attachment loss, no bleeding on probing, with Gingival and Plaque index 0-1.
Group 2 - Plaque induced gingivitis patients:
Ten patients who had plaque induced gingivitis characterized by the presence of any of the following clinical signs: redness and edema of the gingival tissue, bleeding upon provocation, changes in contour and consistency, presence of calculus and/or plaque, with no clinical attachment loss nor radiographic evidence of bone loss.
Group 3 - Chronic periodontitis group:
Ten chronic moderate to severe periodontitis patients selected according to the criteria currently adopted by Armitage 1999. Moderate destruction is generally characterized by periodontal probing depths up to 6 mm with clinical attachment loss of up to 4 mm. Advanced destruction is generally characterized by periodontal probing depths greater than 6 mm with attachment loss greater than 4 mm. Radiographic evidence of bone loss is apparent, Increased tooth mobility may be present.
Group 4 - Aggressive periodontitis group:
Ten patients suffering generalized aggressive periodontitis, patients were less than 35 years of age and had generalized interproximal attachment loss affecting at least 3 permanent teeth other than the first molars and incisors with at least one site each with PD and CAL >5 mm, Attachment loss occurs in pronounced episodic periods of destruction, and there is familial aggregation (subjects were asked if they had at least one other member of the family presenting or with a history of periodontal diseases).
GCF and saliva samples were collected for all patients. Pentraxin-3 levels were evaluated in GCF and saliva of all subjects included in this study with ELISA technique.
- Conditions
- Chronic Periodontitis, Aggressive Periodontitis
- Keywords
- saliva, GCF, pentraxin-3
- Medical subject headings
- Chronic Periodontitis, Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy control | Ten healthy control subjects presented with clinically healthy periodontium. Control subjects had to meet the following criteria for inclusion: probing depth less than 3mm, no clinical attachment loss, no bleeding on probing, with Gingival and Plaque index 0-1. | |
| plaque induced gingivitis | Ten patients who had plaque induced gingivitis characterized by the presence of any of the following clinical signs: redness and edema of the gingival tissue, bleeding upon provocation, changes in contour and consistency, presence of calculus and/or plaque, with no clinical attachment loss nor radiographic evidence of bone loss. | |
| chronic periodontitis | Ten chronic moderate to severe periodontitis patients selected according to the criteria currently adopted by Armitage 1999. Moderate destruction is generally characterized by periodontal probing depths up to 6 mm with clinical attachment loss of up to 4 mm. Advanced destruction is generally characterized by periodontal probing depths greater than 6 mm with attachment loss greater than 4 mm. Radiographic evidence of bone loss is apparent, Increased tooth mobility may be present. | |
| aggressive periodontitis | Ten patients suffering generalized aggressive periodontitis, patients were less than 35 years of age and had generalized interproximal attachment loss affecting at least 3 permanent teeth other than the first molars and incisors with at least one site each with PD and CAL >5 mm, Attachment loss occurs in pronounced episodic periods of destruction, and there is familial aggregation (subjects were asked if they had at least one other member of the family presenting or with a history of periodontal diseases). |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCF and salivary pentraxin-3 levels
levels of pentraxin-3 in GCF and saliva
Measured: baseline
Secondary outcomes (4)
plaque index
Oral hygiene status of the patients were recorded using the plaque index of Silness \& Lӧe (1964)
Measured: baseline
gingival index
Performed using the gingival index of Lӧe (1967)
Measured: baseline
probing pocket depth
The depths of the periodontal pockets were measured as the distance from the gingival margin to the base of the pocket using periodontal probe with William's graduation.
Measured: baseline
clinical attachment level
Clinical attachment levels were measured as the distance from the CEJ to the base of the pocket using William's graduated periodontal probe.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study startDec 2015
- Primary completionFeb 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Ayman Ghallab, Cairo University
- Investigators
- Engy Ahmed, M.D., Study director, Associate Professor of Oral Medicine & Periodontology, faculty of Oral and Dental Medicine, Cairo UniversityYasmine Mansour, B.D.Sc, Principal investigator, master candidate at faculty of dentistry cairo universityOlfat Shaker, Study chair, Professor of Medical Biochemistry, Faculty of Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128502
- Sponsor's protocol ID
- PTX-3_AgP_CP
- Status last verified
- Jun 2017
- First submitted
- 21 Apr 2017
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fujita Y, Ito H, Sekino S, Numabe Y. Correlations between pentraxin 3 or cytokine levels in gingival crevicular fluid and clinical parameters of chronic periodontitis. Odontology. 2012 Jul;100(2):215-21. doi: 10.1007/s10266-011-0042-1. Epub 2011 Sep 20.
PubMed 21932007Lakshmanan R, Jayakumar ND, Sankari M, Padmalatha O, Varghese S. Estimation of pentraxin-3 levels in the gingival tissues of chronic and aggressive periodontitis participants: an in vivo study. J Periodontol. 2014 Feb;85(2):290-7. doi: 10.1902/jop.2013.120718. Epub 2013 May 23.
PubMed 23701480Gumus P, Nizam N, Nalbantsoy A, Ozcaka O, Buduneli N. Saliva and serum levels of pentraxin-3 and interleukin-1beta in generalized aggressive or chronic periodontitis. J Periodontol. 2014 Mar;85(3):e40-6. doi: 10.1902/jop.2013.130281. Epub 2013 Aug 16.
PubMed 23952075
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pentraxin-3 Levels in Gingival Crevicular Fluid and Saliva in Periodontal Health and Disease
- ClinicalTrials.gov ID
- NCT03128502
- Acronym / sponsor ID
- PTX-3_AgP_CP
- Conditions
- Chronic Periodontitis, Aggressive Periodontitis
- Keywords
- saliva, GCF, pentraxin-3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 25 Apr 2017 (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.
Subjects were selected from the outpatient clinic, Department of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University. Ten healthy control subjects presented with clinically healthy periodontium. Ten patients who had plaque induced gingivitis. Ten patients who had generalized chronic periodontitis. Ten patients who had generalised aggressive periodontitis. Pentraxin-3 levels were evaluated in GCF and saliva of all subjects included in this study with ELISA technique.
Detailed description
The study population consisted of 4 groups of forty patients selected as follows:
Group 1 - Healthy Controls:
Ten healthy control subjects presented with clinically healthy periodontium. Control subjects had to meet the following criteria for inclusion: probing depth less than 3mm, no clinical attachment loss, no bleeding on probing, with Gingival and Plaque index 0-1.
Group 2 - Plaque induced gingivitis patients:
Ten patients who had plaque induced gingivitis characterized by the presence of any of the following clinical signs: redness and edema of the gingival tissue, bleeding upon provocation, changes in contour and consistency, presence of calculus and/or plaque, with no clinical attachment loss nor radiographic evidence of bone loss.
Group 3 - Chronic periodontitis group:
Ten chronic moderate to severe periodontitis patients selected according to the criteria currently adopted by Armitage 1999. Moderate destruction is generally characterized by periodontal probing depths up to 6 mm with clinical attachment loss of up to 4 mm. Advanced destruction is generally characterized by periodontal probing depths greater than 6 mm with attachment loss greater than 4 mm. Radiographic evidence of bone loss is apparent, Increased tooth mobility may be present.
Group 4 - Aggressive periodontitis group:
Ten patients suffering generalized aggressive periodontitis, patients were less than 35 years of age and had generalized interproximal attachment loss affecting at least 3 permanent teeth other than the first molars and incisors with at least one site each with PD and CAL >5 mm, Attachment loss occurs in pronounced episodic periods of destruction, and there is familial aggregation (subjects were asked if they had at least one other member of the family presenting or with a history of periodontal diseases).
GCF and saliva samples were collected for all patients. Pentraxin-3 levels were evaluated in GCF and saliva of all subjects included in this study with ELISA technique.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy control | – | –Ten healthy control subjects presented with clinically healthy periodontium. Control subjects had to meet the following criteria for inclusion: probing depth less than 3mm, no clinical attachment loss, no bleeding on probing, with Gingival and Plaque index 0-1. |
| plaque induced gingivitis | – | –Ten patients who had plaque induced gingivitis characterized by the presence of any of the following clinical signs: redness and edema of the gingival tissue, bleeding upon provocation, changes in contour and consistency, presence of calculus and/or plaque, with no clinical attachment loss nor radiographic evidence of bone loss. |
| chronic periodontitis | – | –Ten chronic moderate to severe periodontitis patients selected according to the criteria currently adopted by Armitage 1999. Moderate destruction is generally characterized by periodontal probing depths up to 6 mm with clinical attachment loss of up to 4 mm. Advanced destruction is generally characterized by periodontal probing depths greater than 6 mm with attachment loss greater than 4 mm. Radiographic evidence of bone loss is apparent, Increased tooth mobility may be present. |
| aggressive periodontitis | – | –Ten patients suffering generalized aggressive periodontitis, patients were less than 35 years of age and had generalized interproximal attachment loss affecting at least 3 permanent teeth other than the first molars and incisors with at least one site each with PD and CAL >5 mm, Attachment loss occurs in pronounced episodic periods of destruction, and there is familial aggregation (subjects were asked if they had at least one other member of the family presenting or with a history of periodontal diseases). |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients from the outpatient clinic, Department of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University suffering from diffrent periodontal diseases.
Key inclusion criteria (3 listed)
- patients with plaque induced gingivitis
- patients with chronic periodontitis
- patients with aggressive periodontitis
Key exclusion criteria (4 listed)
- Patients with any systemic disease according to Cornell medical index (1968).
- Patients taking any medications or antibiotics in the last 3 months.
- Current or former smoker patients.
- Pregnant females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GCF and salivary pentraxin-3 levels
Time frame: baseline
levels of pentraxin-3 in GCF and saliva
4 secondary outcomes
plaque index
Time frame: baseline
gingival index
Time frame: baseline
probing pocket depth
Time frame: baseline
clinical attachment level
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Results publication: PubMed 21932007Fujita Y, Ito H, Sekino S, Numabe Y. Correlations between pentraxin 3 or cytokine levels in gingival crevicular fluid and clinical parameters of chronic periodontitis. Odontology. 2012 Jul;100(2):215-21. doi: 10.1007/s10266-011-0042-1. Epub 2011 Sep 20.
- Results publication: PubMed 23701480Lakshmanan R, Jayakumar ND, Sankari M, Padmalatha O, Varghese S. Estimation of pentraxin-3 levels in the gingival tissues of chronic and aggressive periodontitis participants: an in vivo study. J Periodontol. 2014 Feb;85(2):290-7. doi: 10.1902/jop.2013.120718. Epub 2013 May 23.
- Results publication: PubMed 23952075Gumus P, Nizam N, Nalbantsoy A, Ozcaka O, Buduneli N. Saliva and serum levels of pentraxin-3 and interleukin-1beta in generalized aggressive or chronic periodontitis. J Periodontol. 2014 Mar;85(3):e40-6. doi: 10.1902/jop.2013.130281. Epub 2013 Aug 16.
- Individual participant dataSharing planned: No
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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.
Engy Ahmed, M.D. study director
Associate Professor of Oral Medicine & Periodontology, faculty of Oral and Dental Medicine, Cairo University
Yasmine Mansour, B.D.Sc principal investigator
master candidate at faculty of dentistry cairo university
Olfat Shaker study chair
Professor of Medical Biochemistry, Faculty of Medicine, Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Periodontitis and Aggressive Periodontitis, run by Cairo University.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 15 Jun 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
GCF and salivary pentraxin-3 levels (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03128502, which also lists 3 linked publications.
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 15 Jun 2017.