Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Smoking on Non-surgical Periodontal Therapy in Generalized Aggressive 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: NCT03512938
Recruitment Status : Completed
First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
Nurcan Buduneli, Ege University

Brief Summary:
Smoking is the major preventable risk factor in the initiation and progression of periodontal diseases. Periodontitis risk was found to be 3.9 times higher among smokers aged between 19-30 years and 2.8 times higher among smokers aged 31-40 years compared to non-smokers. Aggressive periodontitis (AgP), is characterized by a rapid attachment loss usually incompatible with the amount of plaque and dental calculus. It is often not possible to predict the prognosis of treatment with various treatment options in cases of aggressive periodontitis. It was hypothesized that non-smoker patients with generalized aggressive periodontitis (GAgP) will respond better to conventional mechanical non-surgical periodontal therapy compared to the smokers. Therefore, the aim of this study was to evaluate the effects of smoking on the outcomes of non-surgical periodontal treatment in terms of the clinical, biochemical and microbiological parameters.

Condition or disease Intervention/treatment Phase
Generalized Aggressive Periodontitis Smoking Procedure: Non-surgical periodontal therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Smoking on Non-surgical Periodontal Therapy in Generalized Aggressive Periodontitis
Actual Study Start Date : June 23, 2014
Actual Primary Completion Date : February 8, 2016
Actual Study Completion Date : September 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Active Comparator: Non-smoker Group
This group included non-smoker generalized aggressive periodontitis patients.
Procedure: Non-surgical periodontal therapy
Patients were motivated and instructed to brush with modified Bass technique and use interdental toothbrushes, dental floss. Each patient underwent quadrant scaling and root planning (SRP) under local anaesthesia over a 4-week period. Root planing (RP) was performed under local anaesthesia (2% lidocaine, epinephrine 1:100.000) and a standard curette set newly sharpened with Arkansas stone was used for each patient.

Experimental: Smoker Group
This group included smoker generalized aggressive periodontitis patients.
Procedure: Non-surgical periodontal therapy
Patients were motivated and instructed to brush with modified Bass technique and use interdental toothbrushes, dental floss. Each patient underwent quadrant scaling and root planning (SRP) under local anaesthesia over a 4-week period. Root planing (RP) was performed under local anaesthesia (2% lidocaine, epinephrine 1:100.000) and a standard curette set newly sharpened with Arkansas stone was used for each patient.




Primary Outcome Measures :
  1. Change in Clinical Attachment Level (CAL) [ Time Frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy ]

Secondary Outcome Measures :
  1. Change in Probing Depth (PD) [ Time Frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy ]
  2. Change in Bleeding on Probing (BoP) [ Time Frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy ]
  3. Change in Plaque Index (PI) [ Time Frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy ]
  4. Changing of the salivary biomarkers [ Time Frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy ]
    In the morning following an overnight fast, during which subjects were requested not to drink (except water) or to chew gum, whole saliva samples were obtained by expectorating into polypropylene tubes; clinical periodontal measurements and any necessary periodontal interventions were then carried out. Cytokine levels were assessed by Enzyme-linked immunosorbent assay (ELISA).

  5. Changing of the serum biomarkers [ Time Frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy ]
    Nine milliliters of venous blood were taken from the antecubital vein by a standard venipuncture method and centrifuged for 10 minutes at 3,000 rpm, separating serum from the cells. Cytokine levels were assessed by Enzyme-linked immunosorbent assay (ELISA).

  6. Changing of the gingival crevicular fluid (GCF) biomarkers [ Time Frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy ]
    GCF samples were obtained from buccal aspects of one interproximal site in each quadrant. Supragingival plaque was removed carefully by sterile curettes; the surfaces were dried and isolated by cotton rolls. Filter paper strips were placed in the orifices of the gingival sulcus/pocket for 30 seconds. Care was used to avoid mechanical trauma, and strips contaminated with blood were discarded. The absorbed GCF volume was estimated by a calibrated instrument. The readings of GCF sample volumes were converted to an actual volume (μL) by reference to the standard curve. Cytokine levels were assessed by Enzyme-linked immunosorbent assay (ELISA).

  7. Changing of the amount of pathogen microorganisms [ Time Frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy ]
    Plaque samples were collected from the same sites by sterile paper points from the base of the pockets. Paper points were inserted into the deepest part of the pocket and kept for 5 seconds. Paper points were then placed into propylene tubes. Real-time polymerase chain reaction was used for detection and quantification of bacterial cell copy numbers in 1 mg plaque.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having at least six permanent teeth, including incisors and/or first molars with severe periodontal disease
  • Having at least one site with probing depth (PD) and clinical attachment level (CAL) ≥5 mm and six teeth other than first molars and incisors with similar PD and CAL measurements
  • Familial aggregation

Exclusion Criteria:

  • Medical disorders such as diabetes mellitus, immunological disorders
  • Having an antibiotic or periodontal treatment in the last 6 months
  • Having <15 teeth

Layout table for additonal information
Responsible Party: Nurcan Buduneli, Clinical Professor, Ege University
ClinicalTrials.gov Identifier: NCT03512938     History of Changes
Other Study ID Numbers: 2014-DIS-013
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nurcan Buduneli, Ege University:
Generalized aggressive periodontitis
Non-surgical periodontal therapy
Periodontopathogens
Smoking
Gingival crevicular fluid

Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontitis
Aggressive Periodontitis
Aggression
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms