Prevalence of Porphyromonas Gingivalis Fimbrial Subunit Genotype in Smokers and Nonsmokers After Periodontal Therapy

NCT02879903 | Unknown Early Phase 1 DMC

• 1 other identifier: CAAE: 53022216.0.0000.5626
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aims of the present study will be identify 5 types of fimbrial subunit genotype strains in smokers and nonsmokers with periodontitis, before and after periodontal therapy. Third two periodontitis patients will be selected to these study, 16 nonsmokers and 16 smokers. Clinical and microbiological parameters were evaluated at baseline and 3 months after periodontal treatment: Plaque Index, Bleeding On Probe, Probing Depth, Gingival Recession and Clinical Attachment Level. The prevalence of P. gingivalis and fimbrial subunit gene strains will be determined by Polymerase Chain Reaction.

Conditions

Chronic Periodontitis

Keywords

Porphyromonas gingivalis; Periodontal treatment; Smokers

Outcome Measures

Primary Outcomes (8)

• Change from baseline Bleeding on Probe to 3 months

  Bleeding On Probe will be expressed in percentage per individual to evaluate presence of bleeding on probe.

  3 months

• Change from Baseline Plaque Index to 3 months

  Plaque Index will be expressed in percentage per individual to evaluate presence of plaque.

  3 months

• Change from Baseline Pocket Probing Depth to 3 months

  Pocket Probing Depth will be evaluated in millimeter. The measure will be performed at six sites per tooth using a periodontal probe.

  3 months

• Change from Baseline Gingival Recession to 3months

  Gingival Recession will be evaluated in millimeter. The measure will be performed at six sites per tooth, from cementoenamel junction to gingival margin, using a periodontal probe.

  3 months

• Change from Baseline Clinical Attachment level to 3 months

  Clinical Attachment Level will be evaluated in millimeter. The measure will be performed at six sites per tooth, from cementoenamel junction to the end of periodontal pocket, using a periodontal probe.

  3 months

• Change from Baseline Biofilm to 3 months

  Pooled biofilms from each site with Probe Depth \>5mm will be collected and checked for the presence of fimbrial subunit genotype of Porphyromonas gingivalis I, II, III, IV and V by Polymerase Chain Reaction analysis. The results will be expressed by percentage of frequency of each type of fim A.

  3 months

• Change from baseline Age to 3 months

  Age will be expressed in years.

  3 months

• Change from Baseline Cigarette consumption to 3 months

  Time of cigarette consumption - will be expressed in years.

  3 months

Study Arms (2)

biofilm tobacco effect

EXPERIMENTAL

Group smokers - patients will receive periodontal treatment and biofilm will be collected.

Procedure: Periodontal treatment; Procedure: Microbiological collect; Procedure: Questionnaire

biofilm non smoker effect

EXPERIMENTAL

Group Non Smokers - patients will receive periodontal treatment and biofilm will be collected.

Procedure: Periodontal treatment; Procedure: Microbiological collect; Procedure: Questionnaire

Interventions

Periodontal treatment PROCEDURE

An experienced periodontist will be performed clinical periodontal parameters, including Plaque Index, Bleeding On Probe, Pocket Probing Depth, Gingival Recession, Clinical Attachment Level using a periodontal probe, at six sites per tooth at all teeth, excluding third molars. Quadrant scaling and root planning will be weekly performed on each patient under local anesthesia using periodontal curettes and ultrasonic scalers. The maintenance therapy will be included professional plaque control and Scaling and root planing in recurrent periodontal pockets.

biofilm non smoker effect; biofilm tobacco effect

Microbiological collect PROCEDURE

Biofilm will be collected with the paper point to analyse presence of Porphyromonas gingivalis fimbrial subunit gene type I, II, III, IV and V.

biofilm non smoker effect; biofilm tobacco effect

Questionnaire PROCEDURE

Age will be expressed in years Sex -female and male, will be expressed in percentage. Time of cigarette consumption - will be expressed in years

biofilm non smoker effect; biofilm tobacco effect

Eligibility Criteria

• Age: 27 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of chronic periodontitis Consumption of 10 or more cigarettes/day.

You may not qualify if:

• Diabetes mellitus Osteoporosis Pregnant and lactating females Immune suppressive medication Phenytoin Cyclosporine Calcium channel blockers Immunotherapy or diagnosed as HIV+

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Related Publications (4)

• Lin X, Wu J, Xie H. Porphyromonas gingivalis minor fimbriae are required for cell-cell interactions. Infect Immun. 2006 Oct;74(10):6011-5. doi: 10.1128/IAI.00797-06.

  PMID: 16988281 RESULT

• Zhao L, Wu YF, Meng S, Yang H, OuYang YL, Zhou XD. Prevalence of fimA genotypes of Porphyromonas gingivalis and periodontal health status in Chinese adults. J Periodontal Res. 2007 Dec;42(6):511-7. doi: 10.1111/j.1600-0765.2007.00975.x.

  PMID: 17956463 RESULT

• Amano A, Kuboniwa M, Nakagawa I, Akiyama S, Morisaki I, Hamada S. Prevalence of specific genotypes of Porphyromonas gingivalis fimA and periodontal health status. J Dent Res. 2000 Sep;79(9):1664-8. doi: 10.1177/00220345000790090501.

  PMID: 11023261 RESULT

• Zeller I, Hutcherson JA, Lamont RJ, Demuth DR, Gumus P, Nizam N, Buduneli N, Scott DA. Altered antigenic profiling and infectivity of Porphyromonas gingivalis in smokers and non-smokers with periodontitis. J Periodontol. 2014 Jun;85(6):837-44. doi: 10.1902/jop.2013.130336. Epub 2013 Oct 23.

  PMID: 24147843 RESULT

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Periodontal Index; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dental Health Surveys; Health Surveys; Data Collection; Epidemiologic Methods; Investigative Techniques; Dentistry; Periodontics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Dentistry

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 26, 2016
• Study Start: August 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 30, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share