- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04974502
The Influence of Smoking in Periodontitis Patients, Before and After Nonsurgical Treatment
The Influence of Smoking on Oral Neutrophils and Matrix Metalloproteinase-8 in Periodontitis Patients, Before and After Nonsurgical Treatment
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Non-smoker group
|
Oral hygiene instructions, scaling and root planning.
|
|
Experimental: Smoker group
|
Oral hygiene instructions, scaling and root planning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral neutrophils
Time Frame: At baseline (T0)
|
The number of neutrophils in saliva
|
At baseline (T0)
|
|
Oral neutrophils
Time Frame: After Nonsurgical periodontal treatment one month (T1)
|
The number of neutrophils in saliva
|
After Nonsurgical periodontal treatment one month (T1)
|
|
Oral neutrophils
Time Frame: After Nonsurgical periodontal treatment three months (T3)
|
The number of neutrophils in saliva
|
After Nonsurgical periodontal treatment three months (T3)
|
|
Matrix metalloproteinase-8 (MMP-8)
Time Frame: At baseline (T0).
|
The level of matrix metalloproteinase-8 (MMP-8) in gingival crevicular fluid
|
At baseline (T0).
|
|
Matrix metalloproteinase-8 (MMP-8)
Time Frame: After Nonsurgical periodontal treatment three months (T3)
|
The level of matrix metalloproteinase-8 (MMP-8) in gingival crevicular fluid
|
After Nonsurgical periodontal treatment three months (T3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plaque Index (PlI)
Time Frame: At baseline (T0).
|
Plaque Index (Silness and Loe, 1967)
|
At baseline (T0).
|
|
Plaque Index (PlI)
Time Frame: After Nonsurgical periodontal treatment one month (T1)
|
Plaque Index (Silness and Loe, 1967)
|
After Nonsurgical periodontal treatment one month (T1)
|
|
Plaque Index (PlI)
Time Frame: After Nonsurgical periodontal treatment three months (T3)
|
Plaque Index (Silness and Loe, 1967)
|
After Nonsurgical periodontal treatment three months (T3)
|
|
Gingival Index (GI)
Time Frame: At baseline (T0).
|
Gingival Index (Silness and Loe, 1967)
|
At baseline (T0).
|
|
Gingival Index (GI)
Time Frame: After Nonsurgical periodontal treatment one month (T1)
|
Gingival Index (Silness and Loe, 1967)
|
After Nonsurgical periodontal treatment one month (T1)
|
|
Gingival Index (GI)
Time Frame: After Nonsurgical periodontal treatment three months (T3)
|
Gingival Index (Silness and Loe, 1967)
|
After Nonsurgical periodontal treatment three months (T3)
|
|
Probing pocket depth (PPD)
Time Frame: At baseline (T0).
|
The distance from the gingival margin to pocket base
|
At baseline (T0).
|
|
Probing pocket depth (PPD)
Time Frame: After Nonsurgical periodontal treatment one month (T1)
|
The distance from the gingival margin to pocket base
|
After Nonsurgical periodontal treatment one month (T1)
|
|
Probing pocket depth (PPD)
Time Frame: After Nonsurgical periodontal treatment three months (T3)
|
The distance from the gingival margin to pocket base
|
After Nonsurgical periodontal treatment three months (T3)
|
|
Clinical attachment loss (CAL)
Time Frame: At baseline (T0).
|
The distance from the cementoenamel junction (CEJ) to the gingival margin
|
At baseline (T0).
|
|
Clinical attachment loss (CAL)
Time Frame: After Nonsurgical periodontal treatment three months (T3)
|
The distance from the cementoenamel junction (CEJ) to the gingival margin
|
After Nonsurgical periodontal treatment three months (T3)
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 92/DHYD-HDDD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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