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Completed

NCT Number: NCT04974502

The Influence of Smoking 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.

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Key information

Age range

30 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nonsurgical periodontal treatment

Procedure

Oral hygiene instructions, scaling and root planning.

Primary outcomes

  1. Oral neutrophils

    Time frame: At baseline (T0)

    The number of neutrophils in saliva

  2. Oral neutrophils

    Time frame: After Nonsurgical periodontal treatment one month (T1)

    The number of neutrophils in saliva

  3. Oral neutrophils

    Time frame: After Nonsurgical periodontal treatment three months (T3)

    The number of neutrophils in saliva

  4. Matrix metalloproteinase-8 (MMP-8)

    Time frame: At baseline (T0).

    The level of matrix metalloproteinase-8 (MMP-8) in gingival crevicular fluid

  5. 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

Secondary outcomes

  1. Plaque Index (PlI)

    Time frame: At baseline (T0).

    Plaque Index (Silness and Loe, 1967)

  2. Plaque Index (PlI)

    Time frame: After Nonsurgical periodontal treatment one month (T1)

    Plaque Index (Silness and Loe, 1967)

  3. Plaque Index (PlI)

    Time frame: After Nonsurgical periodontal treatment three months (T3)

    Plaque Index (Silness and Loe, 1967)

  4. Gingival Index (GI)

    Time frame: At baseline (T0).

    Gingival Index (Silness and Loe, 1967)

  5. Gingival Index (GI)

    Time frame: After Nonsurgical periodontal treatment one month (T1)

    Gingival Index (Silness and Loe, 1967)

  6. Gingival Index (GI)

    Time frame: After Nonsurgical periodontal treatment three months (T3)

    Gingival Index (Silness and Loe, 1967)

  7. Probing pocket depth (PPD)

    Time frame: At baseline (T0).

    The distance from the gingival margin to pocket base

  8. Probing pocket depth (PPD)

    Time frame: After Nonsurgical periodontal treatment one month (T1)

    The distance from the gingival margin to pocket base

  9. Probing pocket depth (PPD)

    Time frame: After Nonsurgical periodontal treatment three months (T3)

    The distance from the gingival margin to pocket base

  10. Clinical attachment loss (CAL)

    Time frame: At baseline (T0).

    The distance from the cementoenamel junction (CEJ) to the gingival margin

  11. Clinical attachment loss (CAL)

    Time frame: After Nonsurgical periodontal treatment three months (T3)

    The distance from the cementoenamel junction (CEJ) to the gingival margin

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study title

The Influence of Smoking on Oral Neutrophils and Matrix Metalloproteinase-8 in Periodontitis Patients, Before and After Nonsurgical Treatment

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jul 23, 2021
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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