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

July 20, 2021 updated by: Nguyen Thu Thuy, University of Medicine and Pharmacy at Ho Chi Minh City

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

Completed

Conditions

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

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

July 1, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (Actual)

July 23, 2021

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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