Clinical Conditions and Prevalence of Periodontopathogens in Smokers and Non-smokers After Periodontal Therapy

NCT02581319 | Unknown DMC

• 1 other identifier: E-26/103.243/2012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Smoking has been considered the most important risk factor for periodontitis among all lifestyle factors. Fewer studies evaluated longitudinal clinical and microbiological status of smokers undergoing periodontal maintenance therapy and controversial results were found. This study will evaluate clinical conditions and prevalence of putative periodontopathogens and Candida spp. in smokers and non-smokers at baseline and after 3 and 6 months of nonsurgical periodontal therapy. Clinical parameters, including oral status assessed using Plaque Index (PI), Bleeding On Probe (BOP), Pocket Probing Depth (PPD), Gingival Recession (GR), Clinical Attachment Level (CAL) will be measured in smokers and non-smokers patients with chronic periodontitis. Samples of subgingival biofilm will be obtained from the periodontal pockets and furcation sites and submitted to phenol-chloroform DNA extraction and Polymerase Chain Reaction (PCR) analysis using specific primers for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia, Campylobacter rectus, Candida albicans, Candida glabrata, Candida tropicalis and Candida dublinienses.

Conditions

Periodontal Disease; Smoking

Outcome Measures

Primary Outcomes (2)

• Evaluation of periodontal status represented by means/standard deviations of the percentage of high scores of PI and BOP and levels (mm) of PPD, GR and CAL in smokers and non-smokers patients before and after periodontal treatment

  An experienced periodontist will perform clinical periodontal analysis and periodontal treatment. Six sites (mesio-buccal, mediobuccal, disto-buccal, mesio-lingual, medio-lingual, disto-lingual) of each selected tooth (at least six teeth) will be measured using standard scores for the following periodontal markers: Plaque Index (PI) and Bleeding On Probe (BOP) and determined the levels (mm) of Pocket Probing Depth (PPD), Gingival Recession (GR) and Clinical Attachment Level (CAL) using a periodontal probe PCP15 (PCP-UNC15, Hu-Friedy, Chicago, IL). Means/standard deviations will be calculated from the percentage of high scores of PI and BOP and levels (mm) of PPD, GR and CAL for each patient and after that for each group: smokers and non-smokers. All patients with periodontal disease (high scores of periodontal markers) will be submitted to periodontal treatment and clinically evaluated at baseline, 3 months, 6 months and 1 year after treatment.

  Up to one year

• Prevalence of periodontopathogens calculated in percentage of sites containing the species tested for PCR, comparing smokers and non-smokers

  Gingival crevicular samples will be taken from 4 sites with the deepest PPD (\>5mm) in each patient. DNA from these samples will be extracted using phenol-chloroform method and quantified in a spectrophotometer at 260 nm and stored at -20 °C. Microbial molecular identification will be carried out by PCR with specific primers for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia, Campylobacter rectus, Candida albicans, Candida glabrata, Candida tropicalis and Candida dublinienses. PCR amplification will be performed with a GeneAmp PCR system 2400 (Perkin-Elmer - Applied Biosystems) for TGradient 96 (Biometra, Germany) under thermal conditions specific for each pair of primers. The prevalence of periodontopathogens will be calculated in percentage of sites containing the species tested for PCR, comparing smokers and non-smokers at baseline, 3 months, 6 months and 1 year after periodontal treatment.

  Up to one year

Study Arms (1)

Periodontal treatment

OTHER

Both groups of patients (smokers and non-smokers) will receive periodontal treatment consisting of scaling and planning root, 4 times in the first month and after that once a month until complete one year. Patients will be clinically evaluated and microbiological collects will be made at baseline, 3 months, 6 months and 1 year after periodontal treatment.

Procedure: Periodontal treatment

Interventions

Periodontal treatment PROCEDURE

Periodontal treatment will consist of scaling and planning root, 4 times in the first month and after that once a month until complete one year. Patients will be clinically evaluated and microbiological collects were made at baseline, 3 months, 6 months and 1 year after periodontal treatment.

Also known as: Scaling and planning root

Periodontal treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of periodontal disease in unirradicular teeth
• bleeding on probing in sites where probing depth was ≥5 mm in a minimum of two teeth in different arch;
• radiographic bone loss ranging from 30% to 50%.

You may not qualify if:

• patients with systemic diseases, diabetes; osteoporosis;
• pregnant lactating females;
• use of immune suppressive medication, phenytoin, cyclosporine, calcium channel blockers or any use of antibiotics or nonsteroidal anti-inflammatory drugs in the past 3 months;
• any medical conditions requiring immunotherapy or diagnosed as HIV+ or with AIDS, that could interfere with the periodontium status.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Federal Fluminense University

Nova Friburgo, Rio de Janeiro, 28625-650, Brazil

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases; Smoking

Interventions

Periodontal Index; Tooth Exfoliation

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Dental Health Surveys; Health Surveys; Surveys and Questionnaires; 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; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Cristiane Duque, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Gabriela AC Camargo, PhD

  Federal Fluminense University

  STUDY DIRECTOR

Central Study Contacts

Gabriela AC Camargo, PhD

CONTACT

:+55 22 2528-7168; gaby.3003@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 20, 2015
• Study Start: July 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 21, 2015

Record last verified: 2015-10

Locations

BR (1)