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Nitro-oxidative Stress in Periodontitis

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ClinicalTrials.gov Identifier: NCT02127203
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : October 5, 2015
Sponsor:
Information provided by (Responsible Party):
Damascus University

Brief 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.

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.


Condition or disease
Chronic Periodontitis Aggressive Periodontitis

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Assessment of Nitro - Oxidative Stress in Periodontal Disease
Study Start Date : May 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Group/Cohort
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.



Primary Outcome Measures :
  1. Nitric oxide levels in serum and gingival cervicular fluid [ Time Frame: Within 24 hours after the collection of the serum and gingival fluid ]
    Griess reagent to assess nitric oxide levels as a marker of nitrosative stress.

  2. Malondialdihyide levels in serum and gingival cervicular fluid [ Time Frame: Within 24 hours after the collection of the serum and gingival fluid ]
    TBARS assay (HPLC) will be used to assess the malondialdihyde levels as a marker of oxidative stress.


Secondary Outcome Measures :
  1. Bleeding on Probing (BOP) [ Time Frame: One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision ]
    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)

  2. Plaque Index (PI) [ Time Frame: One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision ]
    A standard periodontal probe will be used for recording periodontal indices at six sites per tooth.

  3. Clinical Attachment Loss (CAL) [ Time Frame: One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision ]
    A standard periodontal probe will be used for recording periodontal indices at six sites per tooth.

  4. Periodontal Pocket Depth (PPD) [ Time Frame: One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision ]
    A standard periodontal probe will be used for recording periodontal indices at six sites per tooth.

  5. Gingival Index (GI). [ Time Frame: One time assessment once sample recruitment has completed. This outcome will be assessed within one week before treatment provision ]
    A standard periodontal probe will be used for recording periodontal indices at six sites per tooth.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion criteria:

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

Exclusion criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127203


Locations
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Syrian Arab Republic
Department of Periodontics, University of Damascus Dental School
Damascus, Syrian Arab Republic, DM20AM18
Sponsors and Collaborators
Damascus University
Investigators
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Principal Investigator: Abeer Alasadi, DDS MSc student, Department of Periodontology, University of Damascus Dental School
Study Director: Ali Abou Sulaiman, DDS MSc Phd Senior Lecturer in Periodontics, University of Damascus Dental School, Damascus
Study Director: Francoise Qarabit, BSc MSc PhD Senior Lecturer in Chemistry, Department of Chemistry, Faculty of Sciences, University of Damascus, Baramkeh, Damascus, Syria
Publications:
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Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT02127203    
Other Study ID Numbers: UDDS-Perio-03-2014
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: October 2015
Keywords provided by Damascus University:
oxidative stress
periodontal disease
nitric oxide
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Aggressive Periodontitis
Mouth Diseases
Stomatognathic Diseases