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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04974502
• Other study ID #: 92/DHYD-HDDD
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: March 2019

Study information

• Verified date: July 2021
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• Nonsurgical periodontal treatment
Oral hygiene instructions, scaling and root planning.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Pharmacy at Ho Chi Minh City

References & Publications (2)

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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral neutrophils	The number of neutrophils in saliva	At baseline (T0)
Primary	Oral neutrophils	The number of neutrophils in saliva	After Nonsurgical periodontal treatment one month (T1)
Primary	Oral neutrophils	The number of neutrophils in saliva	After Nonsurgical periodontal treatment three months (T3)
Primary	Matrix metalloproteinase-8 (MMP-8)	The level of matrix metalloproteinase-8 (MMP-8) in gingival crevicular fluid	At baseline (T0).
Primary	Matrix metalloproteinase-8 (MMP-8)	The level of matrix metalloproteinase-8 (MMP-8) in gingival crevicular fluid	After Nonsurgical periodontal treatment three months (T3)
Secondary	Plaque Index (PlI)	Plaque Index (Silness and Loe, 1967)	At baseline (T0).
Secondary	Plaque Index (PlI)	Plaque Index (Silness and Loe, 1967)	After Nonsurgical periodontal treatment one month (T1)
Secondary	Plaque Index (PlI)	Plaque Index (Silness and Loe, 1967)	After Nonsurgical periodontal treatment three months (T3)
Secondary	Gingival Index (GI)	Gingival Index (Silness and Loe, 1967)	At baseline (T0).
Secondary	Gingival Index (GI)	Gingival Index (Silness and Loe, 1967)	After Nonsurgical periodontal treatment one month (T1)
Secondary	Gingival Index (GI)	Gingival Index (Silness and Loe, 1967)	After Nonsurgical periodontal treatment three months (T3)
Secondary	Probing pocket depth (PPD)	The distance from the gingival margin to pocket base	At baseline (T0).
Secondary	Probing pocket depth (PPD)	The distance from the gingival margin to pocket base	After Nonsurgical periodontal treatment one month (T1)
Secondary	Probing pocket depth (PPD)	The distance from the gingival margin to pocket base	After Nonsurgical periodontal treatment three months (T3)
Secondary	Clinical attachment loss (CAL)	The distance from the cementoenamel junction (CEJ) to the gingival margin	At baseline (T0).
Secondary	Clinical attachment loss (CAL)	The distance from the cementoenamel junction (CEJ) to the gingival margin	After Nonsurgical periodontal treatment three months (T3)