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PeriodontitisNCT04974502

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

A study testing Nonsurgical periodontal treatment in people with Periodontitis, run by University of Medicine and Pharmacy at Ho Chi Minh City.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 30 to 60 years, men only
Conditions the study is for
Periodontitis
What is being tested?
Nonsurgical periodontal treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Jun 2016to Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: 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.

Read the 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.

Conditions
Periodontitis
Being tested
Nonsurgical periodontal treatment
Keywords
periodontitis, smoking, neutrophil, matrix metalloproteinase-8, nonsurgical treatment
Medical subject headings
Periodontitis, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nonsurgical periodontal treatmentProcedure or surgery

    Oral hygiene instructions, scaling and root planning.

Study groups in NCT04974502
Study groupRoleWhat they receive
Non-smoker groupExperimentalNot described
Receives: Procedure: Nonsurgical periodontal treatment
Smoker groupExperimentalNot described
Receives: Procedure: Nonsurgical periodontal treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oral neutrophils

    The number of neutrophils in saliva

    Measured: At baseline (T0)

  2. Oral neutrophils

    The number of neutrophils in saliva

    Measured: After Nonsurgical periodontal treatment one month (T1)

  3. Oral neutrophils

    The number of neutrophils in saliva

    Measured: After Nonsurgical periodontal treatment three months (T3)

  4. Matrix metalloproteinase-8 (MMP-8)

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

    Measured: At baseline (T0).

  5. Matrix metalloproteinase-8 (MMP-8)

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

    Measured: After Nonsurgical periodontal treatment three months (T3)

Secondary outcomes (11)

  1. Plaque Index (PlI)

    Plaque Index (Silness and Loe, 1967)

    Measured: At baseline (T0).

  2. Plaque Index (PlI)

    Plaque Index (Silness and Loe, 1967)

    Measured: After Nonsurgical periodontal treatment one month (T1)

  3. Plaque Index (PlI)

    Plaque Index (Silness and Loe, 1967)

    Measured: After Nonsurgical periodontal treatment three months (T3)

  4. Gingival Index (GI)

    Gingival Index (Silness and Loe, 1967)

    Measured: At baseline (T0).

  5. Gingival Index (GI)

    Gingival Index (Silness and Loe, 1967)

    Measured: After Nonsurgical periodontal treatment one month (T1)

  6. Gingival Index (GI)

    Gingival Index (Silness and Loe, 1967)

    Measured: After Nonsurgical periodontal treatment three months (T3)

  7. Probing pocket depth (PPD)

    The distance from the gingival margin to pocket base

    Measured: At baseline (T0).

  8. Probing pocket depth (PPD)

    The distance from the gingival margin to pocket base

    Measured: After Nonsurgical periodontal treatment one month (T1)

  9. Probing pocket depth (PPD)

    The distance from the gingival margin to pocket base

    Measured: After Nonsurgical periodontal treatment three months (T3)

  10. Clinical attachment loss (CAL)

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

    Measured: At baseline (T0).

  11. Clinical attachment loss (CAL)

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

    Measured: After Nonsurgical periodontal treatment three months (T3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2021
  2. Study startJun 2016
  3. Primary completionDec 2018
  4. Study completionMar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04974502
Sponsor's protocol ID
92/DHYD-HDDD
Status last verified
Jul 2021
First submitted
1 Jul 2021
Last updated
23 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17539718

  • 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.

    PubMed 26644719

  • 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.

    PubMed 37215391

Questions about this trial

What is this clinical trial studying?

A study testing Nonsurgical periodontal treatment in people with Periodontitis, run by University of Medicine and Pharmacy at Ho Chi Minh City.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oral neutrophils (time frame: At baseline (T0)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04974502, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.

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