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Smoking Influence on Apoptosis in Periodontitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02111005
Recruitment Status : Completed
First Posted : April 10, 2014
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Damascus University

Brief Summary:

Apoptosis is an evolutionary form of physiological cell death. Studies suggest that apoptosis is involved in the pathogenesis of periodontal diseases. Human gingival fibroblasts (HGF) have an important role in the periodontal immune response. It is believed that HGF can be diminished and/or eliminated by means of apoptosis.

Smoking is one of the most common risk factor of periodontal disease. Studies indicated that smoking can increase the risk of periodontitis by enhancing the apoptosis of gingival fibroblast.

The purpose of this study is to determine and to investigate apoptosis of HGF in gingival biopsies collected from smokers and non smokers who are diagnosed with chronic periodontitis or aggressive periodontitis.

Eighty subjects will be invited to participate in this study. Patients will be allocated into four groups (20 patients each). Gingival biopsies will be obtained from the base of papillae during surgical treatment (open flap curettage) and will be examined by Immuno-histochemical analysis. Immune-staining will be done using p53 monoclonal mouse anti-human antibody.


Condition or disease
Chronic Periodontitis Aggressive Periodontitis

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Influence of Smoking on Fibroblast Apoptosis in Patients With Chronic and Aggressive Periodontitis
Study Start Date : April 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Group/Cohort
Smoking Aggressive Periodontitis group
This group comprises 20 patients who are smokers and 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.
Smoking Chronic Periodontitis group
This group comprises 20 patients who are smokers and 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)
Non-smoking Aggressive Periodontitis grp
This group comprises 20 patients who are age- and sex- matched to the 'Smoking Aggressive Periodontitis group' and are non-smokers suffering from aggressive periodontitis.
Non-smoking Chronic periodontitis grp
This group comprises 20 patients who are age- and sex-matched to the 'Smoking Chronic Periodontitis group' and are non-smokers suffering from chronic periodontitis.



Primary Outcome Measures :
  1. P53 levels in gingival biopsy samples [ Time Frame: The measurement will be performed at T0 (baseline measurement) once the sample has been recruited ]
    This variable is going to be measured by an immunohistochemical analysis


Secondary Outcome Measures :
  1. presence or absence of fibroblasts' apoptosis in the gingival tissues [ Time Frame: The measurement will be performed at T0 (baseline measurement) once the sample has been recruited ]
    this variable is going to be measured by an immunohistochemical analysis



Information from the National Library of Medicine

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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. Patients should have a diagnosis of periodontitis (either chronic or aggressive). Any candidate will be approached and informed about this clinical study with the relevant information sheet. Informed consent forms will be obtained.Using five clinical parameters and full mouth or panoramic radiographs, the participants will be allocated to four groups according to their condition as well as their smoking habit. The description of these groups has given before.
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 antibiotics or anti-inflammatory 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): NCT02111005


Locations
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Syrian Arab Republic
Ali Abou Sulaiman
Damascus, Syrian Arab Republic, DM20AM18
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: Ali Abou Sulaiman, DDS MSc PhD University of Damascus Dental School, Department of Periodontology
Study Director: Sharif Barakat, DDS MSc Phd University of Damascus Dental School, Department of Periodontology
Publications:
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Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT02111005    
Other Study ID Numbers: UDDS-Perio-01-2014
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Keywords provided by Damascus University:
apoptosis
periodontal disease
smoking
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Aggressive Periodontitis
Aggression
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms