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Chronic PeriodontitisNCT02127203

Nitro-oxidative Stress in Periodontitis

An observational study of Chronic Periodontitis and Aggressive Periodontitis, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Periodontitis is a chronic inflammatory disease whose etio-pathogencity is not fully understood yet. Reactive oxygen species (ROS) and reactive nitrogen species (RNS) are involved in physiological and pathological processes. Nitro-oxidative stress has been implicated in Periodontitis. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Type of treatment
Pill or oral medicine
How many people
80 participants
Where
1 siteSyria
Study dates
May 2014to Oct 2015
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 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: A total of 80 subjects will be invited to participate in this study from the patients referred to the Department of Periodontology, Faculty of Dentistry, University of Damascus. The study has been pproved by our local Review Board. Subjects will be recruited according to specific inclusion criteria after completion of medical and dental history questionnaires. Patients will sign a consent form after being advised about the nature of the study. The selection of patients will be made according of the criteria approved by the 1999 international world workshop for a classification system of periodontal diseases and conditions (Armitage 1999) using five clinical parameters and full mouth or panoramic radiographs for diagnosis.

Who may be able to join

  • Patients of Syrian descent
  • Systemically healthy
  • Have at least 20 teeth

Who cannot join

  • Periodontal treatment during the last three months,
  • History of major systemic diseases
  • Consumption of anti oxidant supplements, antibiotics, anti inflammatory or any other drugs in the last three months
  • Smoking
  • Alcohol consumption
  • Pregnant and lactating women.

Trial locations and contacts

1 site in 1 country.

Syria1 site
  • Department of Periodontics, University of Damascus Dental School

    Damascus, Rif-dimashq Governorate, DM20AM18

Other trials in Syria

About this study

Official title: Assessment of Nitro - Oxidative Stress in Periodontal Disease

Periodontitis is a chronic inflammatory disease whose etio-pathogencity is not fully understood yet. Reactive oxygen species (ROS) and reactive nitrogen species (RNS) are involved in physiological and pathological processes. Nitro-oxidative stress has been implicated in Periodontitis.

The aim of this study is to assess the levels of ROS and RNS in serum and gingival crevicular fluid (GCF) samples taken from periodontitis (chronic and aggressive) patients and healthy controls. Subsequently, correlating these levels with the severity of periodontal disease.

Eighty subjects will be invited to participate in this study. Patients will be allocated into four groups (20 patients each). The biochemical parameters that will be investigated are Malondialdehyde (MDA) (using TBRSA assay) as a marker of oxidative stress and (NO- level using Griess reagent) as a marker of nitrosative stress.

Read the detailed description

Introduction:

Teeth and their supporting periodontal structures are of great importance in good oral health. Periodontitis is an inflammatory disease of the periodontium which affects the supporting tissues of the teeth. The disease is multifaceted and its etio-pathogenecity is still not fully understood and therefore the treatment of different types of periodontal disease can be very difficult. Numerous risk factors have been implicated in the disease process including risk determinants and risk indicators. Most recently, strong body of evidence has accumulated to support a role for reactive oxygen (ROS) and nitrogen species (RNS) either as trigger agents or more frequently, aggravators of the primary lesions in periodontitis.

Oxygen and nitrogen reactive species are involved in a large number of physiological and pathological processes. ROS generated by monocytes and neutrophyles during inflammation are important aggression factors in the periodontal tissues. ROS play an important role in activation of osteoclasts and in bone resorption.

Oxidative stress is a condition arising when there is a serious imbalance between the levels of free radicals in a cell and its antioxidant defenses in favor of the former. Thus, tissue damage can result when antioxidant systems are unable to counteract the free radicals actions efficiently. Inflammation when stimulated by bacterial pathogens, host cells release proinflammatory cytokines (IL-1α, IL-6, IL-8, and tumor necrosis factor-α) as part of immune response. These cytokines recruit polymorphonuclear cells (PMNs) that play a major role in the etiology of periodontal disease by producing proteolytic enzymes, such as elastase and O2 (molecular oxygen) by the oxidative burst.

In a recent study, Abou Sulaiman \& Shehadeh found that serum total antioxidant capacity (TAS) was lower in non-smokers Syrian patients with chronic periodontitis compared to healthy controls. Also, they reported that periodontal treatment restored TAS levels to normal levels similar to healthy controls.

The aim of this study is to assess the levels of ROS and RNS in serum and gingival crevicular fluid (GCF) samples taken from periodontitis patients (chronic and aggressive) and healthy controls. Subsequently, correlating these levels with severity of periodontal disease in Syrian patients.

Materials and methods:

A total of 80 subjects will be invited to participate in this study from the patients referred to the Department of Periodontology, Faculty of Dentistry, University of Damascus. The study has been approved by our local Review Board. Subjects will be recruited according to specific inclusion criteria after completion of medical and dental history questionnaires. Patients will sign a consent form after being advised about the nature of the study.

The selection of patients will be made according of the criteria approved by the 1999 international world workshop for a classification system of periodontal diseases and conditions using five clinical parameters and full mouth or panoramic radiographs for diagnosis.

Subjects will be allocated into four groups:

  • Chronic Periodontitis group (ChP): comprise 20 patients aged > 45 years and have presence of ≥2 non-adjacent sites per quadrant that were not first molars or incisors, with probing depth (PD) ≥5 mm, which bleed on gentle probing. The demonstrated radiographic bone loss ≥30% of the root length, patient with poor oral hygiene, the amount of accumulated plaque commensurate with the amount of clinical attachment level (CAL)
  • Resistant Control group (R): comprise 20 age-sex matched patients who are > 45 years exhibit no signs of periodontal disease as determined by the absence of the evidence of interproximal (CAL ≤ 1mm), PD > 3 mm at any site, whole-mouth bleeding scores <10% and have no clinical signs of gingival inflammation .
  • Aggressive Periodontitis group (AgP): comprise 20 patients who are aged < 35 years and diagnosed with rapid attachment loss with periodontal pocket depth (PD) > 4 mm around at least three teeth other than the first molars and incisors. Rapid bone destruction (>50%bone loss at diseased sites). Weak relationship between dental plaque and the severity of gingival inflammation.
  • Young Control group (YC): comprise 20 age- and sex matched patients who are < 35 years and exhibit no signs of periodontal disease.

Clinical measurements:

A standard periodontal probe will be used for recording periodontal indices at six sites per tooth. The examined clinical parameters include bleeding on probing (BOP), plaque index (PI), clinical attachment loss (CAL) and periodontal pocket depth (PPD) and gingival index (GI).

Collection of samples

Subjects will be asked to refrain from brushing within 1 hour of sampling. (GCF) samples will be obtained using standard paper strips (Periocol strips, Oraflow, NY, USA). 6 samples from each individual (mesiofacial, distopalatal) sites from each examined tooth (incisor, premolar and molar) in the maxilla (Chapple et al. 2002). Strips will be put in PBS Buffer solution for 30 minutes then extracted and stored under liquid nitrogen.

Venous blood samples will be collected from the antecubital fossa and stored in lithium heparin tubes and allowed to stand for 30 minutes before being centrifuged at 1000 ×g for 30 minutes, samples will be aliquoted into cryogenic vials and will be stored under liquid nitrogen.

Laboratory studies:

  • TBARS assay (HPLC) will be used to assess the malondialdihyde levels as a marker of oxidative stress.
  • Griess reagent to assess nitric oxide levels as a marker of nitrosative stress.
Keywords
oxidative stress, periodontal disease, nitric oxide
Medical subject headings
Chronic Periodontitis, Aggressive Periodontitis, Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02127203
Study groupRoleWhat they receive
Chronic Periodontitis group (ChP)20 patients aged > 45 years and have presence of ≥2 non-adjacent sites per quadrant that were not first molars or incisors, with probing depth (PD) ≥5 mm, which bleed on gentle probing. The demonstrated radiographic bone loss ≥30% of the root length, patient with poor oral hygiene, the amount of accumulated plaque commensurate with the amount of clinical attachment level (CAL)
Resistant Control group (R)20 age-sex matched patients who are > 45 years exhibit no signs of periodontal disease as determined by the absence of the evidence of interproximal (CAL ≤ 1mm), PD > 3 mm at any site, whole-mouth bleeding scores <10% and have no clinical signs of gingival inflammation .
Aggressive Periodontitis group (AgP)20 patients who are aged < 35 years and diagnosed with rapid attachment loss with periodontal pocket depth (PD) > 4 mm around at least three teeth other than the first molars and incisors. Rapid bone destruction (>50%bone loss at diseased sites). Weak relationship between dental plaque and the severity of gingival inflammation.
Young Control group (YC)20 age- and sex matched patients who are < 35 years and exhibit no signs of periodontal disease.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nitric oxide levels in serum and gingival cervicular fluid

    Griess reagent to assess nitric oxide levels as a marker of nitrosative stress.

    Measured: Within 24 hours after the collection of the serum and gingival fluid

  2. Malondialdihyide levels in serum and gingival cervicular fluid

    TBARS assay (HPLC) will be used to assess the malondialdihyde levels as a marker of oxidative stress.

    Measured: Within 24 hours after the collection of the serum and gingival fluid

Secondary outcomes (5)
  1. Bleeding on Probing (BOP)

    A standard periodontal probe will be used for recording periodontal indices at six sites per tooth. The examined clinical parameters include bleeding on probing (BOP)

    Measured: One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision

  2. Plaque Index (PI)

    A standard periodontal probe will be used for recording periodontal indices at six sites per tooth.

    Measured: One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision

  3. Clinical Attachment Loss (CAL)

    A standard periodontal probe will be used for recording periodontal indices at six sites per tooth.

    Measured: One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision

  4. Periodontal Pocket Depth (PPD)

    A standard periodontal probe will be used for recording periodontal indices at six sites per tooth.

    Measured: One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision

  5. Gingival Index (GI).

    A standard periodontal probe will be used for recording periodontal indices at six sites per tooth.

    Measured: One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionSep 2015
  4. Study completionOct 2015

Resources

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
Case-control
Time perspective
Cross-sectional
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02127203
Sponsor's protocol ID
UDDS-Perio-03-2014
Status last verified
Oct 2015
First submitted
25 Apr 2014
Last updated
5 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Abou Sulaiman AE, Shehadeh RM. Assessment of total antioxidant capacity and the use of vitamin C in the treatment of non-smokers with chronic periodontitis. J Periodontol. 2010 Nov;81(11):1547-54. doi: 10.1902/jop.2010.100173. Epub 2010 Jun 22.

    PubMed 20569170
  • Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. doi: 10.1902/annals.1999.4.1.1.

    PubMed 10863370
  • Chapple IL, Matthews JB. The role of reactive oxygen and antioxidant species in periodontal tissue destruction. Periodontol 2000. 2007;43:160-232. doi: 10.1111/j.1600-0757.2006.00178.x. No abstract available.

    PubMed 17214840
  • Halliwell B. Reactive oxygen species in living systems: source, biochemistry, and role in human disease. Am J Med. 1991 Sep 30;91(3C):14S-22S. doi: 10.1016/0002-9343(91)90279-7.

    PubMed 1928205
  • Kinane DF. Causation and pathogenesis of periodontal disease. Periodontol 2000. 2001;25:8-20. doi: 10.1034/j.1600-0757.2001.22250102.x. No abstract available.

    PubMed 11155179
  • Sies H. Oxidative stress: oxidants and antioxidants. Exp Physiol. 1997 Mar;82(2):291-5. doi: 10.1113/expphysiol.1997.sp004024.

    PubMed 9129943
  • Wactawski-Wende J. Periodontal diseases and osteoporosis: association and mechanisms. Ann Periodontol. 2001 Dec;6(1):197-208. doi: 10.1902/annals.2001.6.1.197.

    PubMed 11887465

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Periodontitis and Aggressive Periodontitis, run by Damascus University at 1 site in Syria.

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 6 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 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Nitric oxide levels in serum and gingival cervicular fluid (time frame: Within 24 hours after the collection of the serum and gingival fluid). 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?

On the ClinicalTrials.gov record for NCT02127203, which also lists 7 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 5 Oct 2015.

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Nitro-oxidative Stress in Periodontitis (NCT02127203) | AzTrials