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The Influence of Smoking in Periodontitis Patients, Before and After Nonsurgical Treatment

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nonsurgical periodontal treatment
Sponsored by
University of Medicine and Pharmacy at Ho Chi Minh City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, smoking, neutrophil, matrix metalloproteinase-8, nonsurgical treatment

Eligibility Criteria

30 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male patients
  • Aged from 30 to 60 years old
  • Systemically healthy
  • Having at least 20 teeth
  • Diagnosed with moderate to severe periodontitis according to american academy of periodontology 2015: gingival bleeding at examination, ≥5mm periodontal pocket depth (PPD), bone resorption on x-ray film ≥16% or >3mm root length
  • Having at least two sites at anterior teeth with PPD from 5 to 7 mm
  • For group 1, subjects who never smoke
  • For group 2, subjects who had smoked more than 10 cigarettes per day for at least the past 10 years

Exclusion Criteria:

  • Patients with acute or chronic medical disorders
  • Patients under any medication for the past 3 months
  • Patients who had undergone periodontal therapy in the last 12 months
  • Patients with oral lesions such as ulcers, aphthous ulcers, glossitis or multi tooth decays

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Non-smoker group

    Smoker group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Oral neutrophils
    The number of neutrophils in saliva
    Oral neutrophils
    The number of neutrophils in saliva
    Oral neutrophils
    The number of neutrophils in saliva
    Matrix metalloproteinase-8 (MMP-8)
    The level of matrix metalloproteinase-8 (MMP-8) in gingival crevicular fluid
    Matrix metalloproteinase-8 (MMP-8)
    The level of matrix metalloproteinase-8 (MMP-8) in gingival crevicular fluid

    Secondary Outcome Measures

    Plaque Index (PlI)
    Plaque Index (Silness and Loe, 1967)
    Plaque Index (PlI)
    Plaque Index (Silness and Loe, 1967)
    Plaque Index (PlI)
    Plaque Index (Silness and Loe, 1967)
    Gingival Index (GI)
    Gingival Index (Silness and Loe, 1967)
    Gingival Index (GI)
    Gingival Index (Silness and Loe, 1967)
    Gingival Index (GI)
    Gingival Index (Silness and Loe, 1967)
    Probing pocket depth (PPD)
    The distance from the gingival margin to pocket base
    Probing pocket depth (PPD)
    The distance from the gingival margin to pocket base
    Probing pocket depth (PPD)
    The distance from the gingival margin to pocket base
    Clinical attachment loss (CAL)
    The distance from the cementoenamel junction (CEJ) to the gingival margin
    Clinical attachment loss (CAL)
    The distance from the cementoenamel junction (CEJ) to the gingival margin

    Full Information

    First Posted
    July 1, 2021
    Last Updated
    July 20, 2021
    Sponsor
    University of Medicine and Pharmacy at Ho Chi Minh City
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04974502
    Brief Title
    The Influence of Smoking in Periodontitis Patients, Before and After Nonsurgical Treatment
    Official Title
    The Influence of Smoking on Oral Neutrophils and Matrix Metalloproteinase-8 in Periodontitis Patients, Before and After Nonsurgical Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (Actual)
    Primary Completion Date
    December 2018 (Actual)
    Study Completion Date
    March 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Medicine and Pharmacy at Ho Chi Minh City

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Objective: The aim of this study was to evaluate and compare the oral neutrophil numbers (ONN) in saliva, the level of matrix metalloproteinase-8 (MMP-8) in gingival crevicular fluid (GCF) and the periodontal parameters in smokers and non-smokers with periodontitis, before and after nonsurgical periodontal treatment (NSPT). Materials and method: 40 periodontitis patients including 20 smokers and 20 non-smokers were enrolled in this study. All patients were received the NSPT included instructing oral hygiene, scaling and root planning. Clinical parameters (plaque index (PlI), gingival index (GI), bleeding on probing (BOP), probing pocket depth (PPD) and clinical attachment loss (CAL)), ONN and GCF MMP-8 level were assessed before (baseline) and after NSPT 1 month and 3 months.
    Detailed Description
    After periodontal examination and medical history evaluation, all patients received oral hygiene instructions. The modified-Bass tooth brushing technique, as well as the use of dental floss and interproximal brushes (if needed) were showed to the patients. They were educated to brush their teeth at least twice a day. All patients were given a dentifrice and toothbrush. Patient motivation to quit smoking was also provided. At the first visit, supragingival scaling with ultrasonic scalers (Cavitron Jet Plus (Densply Sirona, Mississauga, Canada) were provided to all patients. Occlusion adjustments were also performed in the case of indications. After one week, the baseline (T0) parameters were recorded. The following samples were collected: (1) saliva, (2) gingival cervical fluid (GCF), and (3) clinical periodontal parameters. A doctor who collected the samples was blinded about the smoking status. Subsequently, scaling and root planning (SRP) by ultrasonic scalers (Cavitron Jet Plus (Densply Sirona, Mississauga, Canada) and Gracey curettes (Hu-Friedy, Chicago, USA), under local anesthesia, were performed by a periodontist, who was also blinded about the smoking status. The number of SRP visits was determined by patient disease conditions. Following the completion of NSPT, all subjects were recalled after one month and three months for re-evaluation. The collection of (1) saliva, (2) gingival cervical fluid (GCF), and (3) clinical periodontal parameters were performed. Based on the patients' periodontal status, supragingival scaling and polishing were given.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis
    Keywords
    periodontitis, smoking, neutrophil, matrix metalloproteinase-8, nonsurgical treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Non-smoker group
    Arm Type
    Experimental
    Arm Title
    Smoker group
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Nonsurgical periodontal treatment
    Intervention Description
    Oral hygiene instructions, scaling and root planning.
    Primary Outcome Measure Information:
    Title
    Oral neutrophils
    Description
    The number of neutrophils in saliva
    Time Frame
    At baseline (T0)
    Title
    Oral neutrophils
    Description
    The number of neutrophils in saliva
    Time Frame
    After Nonsurgical periodontal treatment one month (T1)
    Title
    Oral neutrophils
    Description
    The number of neutrophils in saliva
    Time Frame
    After Nonsurgical periodontal treatment three months (T3)
    Title
    Matrix metalloproteinase-8 (MMP-8)
    Description
    The level of matrix metalloproteinase-8 (MMP-8) in gingival crevicular fluid
    Time Frame
    At baseline (T0).
    Title
    Matrix metalloproteinase-8 (MMP-8)
    Description
    The level of matrix metalloproteinase-8 (MMP-8) in gingival crevicular fluid
    Time Frame
    After Nonsurgical periodontal treatment three months (T3)
    Secondary Outcome Measure Information:
    Title
    Plaque Index (PlI)
    Description
    Plaque Index (Silness and Loe, 1967)
    Time Frame
    At baseline (T0).
    Title
    Plaque Index (PlI)
    Description
    Plaque Index (Silness and Loe, 1967)
    Time Frame
    After Nonsurgical periodontal treatment one month (T1)
    Title
    Plaque Index (PlI)
    Description
    Plaque Index (Silness and Loe, 1967)
    Time Frame
    After Nonsurgical periodontal treatment three months (T3)
    Title
    Gingival Index (GI)
    Description
    Gingival Index (Silness and Loe, 1967)
    Time Frame
    At baseline (T0).
    Title
    Gingival Index (GI)
    Description
    Gingival Index (Silness and Loe, 1967)
    Time Frame
    After Nonsurgical periodontal treatment one month (T1)
    Title
    Gingival Index (GI)
    Description
    Gingival Index (Silness and Loe, 1967)
    Time Frame
    After Nonsurgical periodontal treatment three months (T3)
    Title
    Probing pocket depth (PPD)
    Description
    The distance from the gingival margin to pocket base
    Time Frame
    At baseline (T0).
    Title
    Probing pocket depth (PPD)
    Description
    The distance from the gingival margin to pocket base
    Time Frame
    After Nonsurgical periodontal treatment one month (T1)
    Title
    Probing pocket depth (PPD)
    Description
    The distance from the gingival margin to pocket base
    Time Frame
    After Nonsurgical periodontal treatment three months (T3)
    Title
    Clinical attachment loss (CAL)
    Description
    The distance from the cementoenamel junction (CEJ) to the gingival margin
    Time Frame
    At baseline (T0).
    Title
    Clinical attachment loss (CAL)
    Description
    The distance from the cementoenamel junction (CEJ) to the gingival margin
    Time Frame
    After Nonsurgical periodontal treatment three months (T3)

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    Smoking male
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male patients Aged from 30 to 60 years old Systemically healthy Having at least 20 teeth Diagnosed with moderate to severe periodontitis according to american academy of periodontology 2015: gingival bleeding at examination, ≥5mm periodontal pocket depth (PPD), bone resorption on x-ray film ≥16% or >3mm root length Having at least two sites at anterior teeth with PPD from 5 to 7 mm For group 1, subjects who never smoke For group 2, subjects who had smoked more than 10 cigarettes per day for at least the past 10 years Exclusion Criteria: Patients with acute or chronic medical disorders Patients under any medication for the past 3 months Patients who had undergone periodontal therapy in the last 12 months Patients with oral lesions such as ulcers, aphthous ulcers, glossitis or multi tooth decays

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    17539718
    Citation
    Al-Ghamdi HS, Anil S. Serum antibody levels in smoker and non-smoker saudi subjects with chronic periodontitis. J Periodontol. 2007 Jun;78(6):1043-50. doi: 10.1902/jop.2007.060431.
    Results Reference
    result
    PubMed Identifier
    26644719
    Citation
    Akbari G, Prabhuji ML, Karthikeyan BV, Raghunatha K, Narayanan R. Analysis of matrix metalloproteinase-8 levels in gingival crevicular fluid and whole mouth fluid among smokers and nonsmokers using enzyme-linked immune-sorbent assay and a novel chair-side test. J Indian Soc Periodontol. 2015 Sep-Oct;19(5):525-30. doi: 10.4103/0972-124X.162201.
    Results Reference
    result

    Learn more about this trial

    The Influence of Smoking in Periodontitis Patients, Before and After Nonsurgical Treatment

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