NCT04974502

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

2.5 years

First QC Date

July 1, 2021

Last Update Submit

July 20, 2021

Conditions

Keywords

periodontitissmokingneutrophilmatrix metalloproteinase-8nonsurgical treatment

Outcome Measures

Primary Outcomes (5)

  • Oral neutrophils

    The number of neutrophils in saliva

    At baseline (T0)

  • Oral neutrophils

    The number of neutrophils in saliva

    After Nonsurgical periodontal treatment one month (T1)

  • Oral neutrophils

    The number of neutrophils in saliva

    After Nonsurgical periodontal treatment three months (T3)

  • Matrix metalloproteinase-8 (MMP-8)

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

    At baseline (T0).

  • 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 Outcomes (11)

  • Plaque Index (PlI)

    At baseline (T0).

  • Plaque Index (PlI)

    After Nonsurgical periodontal treatment one month (T1)

  • Plaque Index (PlI)

    After Nonsurgical periodontal treatment three months (T3)

  • Gingival Index (GI)

    At baseline (T0).

  • Gingival Index (GI)

    After Nonsurgical periodontal treatment one month (T1)

  • +6 more secondary outcomes

Study Arms (2)

Non-smoker group

EXPERIMENTAL
Procedure: Nonsurgical periodontal treatment

Smoker group

EXPERIMENTAL
Procedure: Nonsurgical periodontal treatment

Interventions

Oral hygiene instructions, scaling and root planning.

Non-smoker groupSmoker group

Eligibility Criteria

Age30 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsSmoking male
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

  • Do HT, Nguyen TT, Vo TL, Huynh NC, Nguyen ATK. The influence of smoking on oral neutrophils and matrix metalloproteinase-8 in periodontitis patients before and after nonsurgical treatment. J Oral Biol Craniofac Res. 2023 May-Jun;13(3):442-447. doi: 10.1016/j.jobcr.2023.05.004. Epub 2023 May 8.

MeSH Terms

Conditions

PeriodontitisSmoking

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean of Faculty of Odonto-stomatology

Study Record Dates

First Submitted

July 1, 2021

First Posted

July 23, 2021

Study Start

June 1, 2016

Primary Completion

December 1, 2018

Study Completion

March 1, 2019

Last Updated

July 23, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share