Clinical trial NCT04974502: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: periodontitis
smoking
neutrophil
matrix metalloproteinase-8
nonsurgical treatment
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 40
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Oral neutrophils
timeFrame: At baseline (T0)
measure: Oral neutrophils
timeFrame: After Nonsurgical periodontal treatment one month (T1)
measure: Oral neutrophils
timeFrame: After Nonsurgical periodontal treatment three months (T3)
measure: Matrix metalloproteinase-8 (MMP-8)
timeFrame: At baseline (T0).
measure: Matrix metalloproteinase-8 (MMP-8)
timeFrame: After Nonsurgical periodontal treatment three months (T3)
Secondary outcomes:
measure: Plaque Index (PlI)
timeFrame: At baseline (T0).
measure: Plaque Index (PlI)
timeFrame: After Nonsurgical periodontal treatment one month (T1)
measure: Plaque Index (PlI)
timeFrame: After Nonsurgical periodontal treatment three months (T3)
measure: Gingival Index (GI)
timeFrame: At baseline (T0).
measure: Gingival Index (GI)
timeFrame: After Nonsurgical periodontal treatment one month (T1)
measure: Gingival Index (GI)
timeFrame: After Nonsurgical periodontal treatment three months (T3)
measure: Probing pocket depth (PPD)
timeFrame: At baseline (T0).
measure: Probing pocket depth (PPD)
timeFrame: After Nonsurgical periodontal treatment one month (T1)
measure: Probing pocket depth (PPD)
timeFrame: After Nonsurgical periodontal treatment three months (T3)
measure: Clinical attachment loss (CAL)
timeFrame: At baseline (T0).
measure: Clinical attachment loss (CAL)
timeFrame: After Nonsurgical periodontal treatment three months (T3)
Other outcomes:
Locations:
Study officials:
References:
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.
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.