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

About this trial
This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, smoking, neutrophil, matrix metalloproteinase-8, nonsurgical treatment
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
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
NCT ID
NCT04974502
First Posted
July 1, 2021
Last Updated
July 20, 2021
Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
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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