Nitro-oxidative Stress in Periodontitis

NCT02127203 | Completed DMC

• 1 other identifier: UDDS-Perio-03-2014
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis; Aggressive Periodontitis

Keywords

oxidative stress; periodontal disease; nitric oxide

Outcome Measures

Primary Outcomes (2)

• Nitric oxide levels in serum and gingival cervicular fluid

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

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

• 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.

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

Secondary Outcomes (5)

• Bleeding on Probing (BOP)

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

• Plaque Index (PI)

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

• Clinical Attachment Loss (CAL)

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

• Periodontal Pocket Depth (PPD)

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

• Gingival Index (GI).

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

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Periodontics, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, DM20AM18, Syria

Location

Related Publications (7)

• 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.

  PMID: 20569170 BACKGROUND

• 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.

  PMID: 10863370 BACKGROUND

• 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.

  PMID: 17214840 BACKGROUND

• 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.

  PMID: 1928205 BACKGROUND

• 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.

  PMID: 11155179 BACKGROUND

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

  PMID: 9129943 BACKGROUND

• 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.

  PMID: 11887465 BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis; Aggressive Periodontitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Periodontitis; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Abeer Alasadi, DDS

  MSc student, Department of Periodontology, University of Damascus Dental School

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: April 30, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 5, 2015

Record last verified: 2015-10

Locations

SY (1)