Smoking Influence on Apoptosis in Periodontitis

NCT02111005 | Completed DMC

• 1 other identifier: UDDS-Perio-01-2014
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Periodontitis; Aggressive Periodontitis

Keywords

apoptosis; periodontal disease; smoking

Outcome Measures

Primary Outcomes (1)

• P53 levels in gingival biopsy samples

  This variable is going to be measured by an immunohistochemical analysis

  The measurement will be performed at T0 (baseline measurement) once the sample has been recruited

Secondary Outcomes (1)

• presence or absence of fibroblasts' apoptosis in the gingival tissues

  The measurement will be performed at T0 (baseline measurement) once the sample has been recruited

Study Arms (4)

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.

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. 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.

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 antibiotics or anti-inflammatory drugs in the last three months
• Smoking
• Alcohol consumption
• Pregnant and lactating women.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (2)

Department of Periodontics, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, DM20AM18, Syria

Location

Ali Abou Sulaiman

Damascus, Syrian Arab Republic, DM20AM18, Syria

Location

Related Publications (8)

• 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

• Bostrom L, Linder LE, Bergstrom J. Clinical expression of TNF-alpha in smoking-associated periodontal disease. J Clin Periodontol. 1998 Oct;25(10):767-73. doi: 10.1111/j.1600-051x.1998.tb02368.x.

  PMID: 9797047 BACKGROUND

• Bulut S, Uslu H, Ozdemir BH, Bulut OE. Expression of caspase-3, p53 and Bcl-2 in generalized aggressive periodontitis. Head Face Med. 2006 Jun 20;2:17. doi: 10.1186/1746-160X-2-17.

  PMID: 16787530 BACKGROUND

• Chen Y, Zychlinsky A. Apoptosis induced by bacterial pathogens. Microb Pathog. 1994 Oct;17(4):203-12. doi: 10.1006/mpat.1994.1066.

  PMID: 7715420 BACKGROUND

• Jarnbring F, Somogyi E, Dalton J, Gustafsson A, Klinge B. Quantitative assessment of apoptotic and proliferative gingival keratinocytes in oral and sulcular epithelium in patients with gingivitis and periodontitis. J Clin Periodontol. 2002 Dec;29(12):1065-71. doi: 10.1034/j.1600-051x.2002.291203.x.

  PMID: 12492905 BACKGROUND

• Hanioka T, Tanaka M, Ojima M, Takaya K, Matsumori Y, Shizukuishi S. Oxygen sufficiency in the gingiva of smokers and non-smokers with periodontal disease. J Periodontol. 2000 Dec;71(12):1846-51. doi: 10.1902/jop.2000.71.12.1846.

  PMID: 11156041 BACKGROUND

• Renehan AG, Booth C, Potten CS. What is apoptosis, and why is it important? BMJ. 2001 Jun 23;322(7301):1536-8. doi: 10.1136/bmj.322.7301.1536. No abstract available.

  PMID: 11420279 BACKGROUND

• Shivanaikar S, Faizuddin M and Bhatt K. Influence of smoking on fibroblast apoptosis in chronic periodontitis. RGUHS J Dent Sciences. 2001; 3: 9-14

  BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis; Aggressive Periodontitis; Periodontal Diseases; Smoking

Condition Hierarchy (Ancestors)

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

Study Officials

• Ali Abou Sulaiman, DDS MSc PhD

  University of Damascus Dental School, Department of Periodontology

  PRINCIPAL INVESTIGATOR

• Sharif Barakat, DDS MSc Phd

  University of Damascus Dental School, Department of Periodontology

  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: March 14, 2014
• First Posted: April 10, 2014
• Study Start: April 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

SY (2)