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CompletedNCT04846166Updated Apr 19, 2021

I-Smads in Periodontitis

An observational study in Periodontitis and Treatment Adherence, sponsored by Bulent Ecevit University. Completed at 1 site in Turkey. Open to participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-19.

Sponsored by Bulent Ecevit University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Ages
25 Years to 55 Years
Sex
All
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Study summary

Recently, it has been stated that Smads play an active role in all conditions where transforming growth factor-beta (TGF-β) is involved, including periodontal inflammation. This study aimed to examine the levels of TGF-β and inhibitor Smads in saliva and gingival crevicular fluid (GCF) in patients with Stage 3 Grade B periodontitis before and after non-surgical periodontal treatment. Twenty (20) stage 3 grade B periodontitis and 20 periodontally healthy individuals were included in the study. Clinical periodontal measurements were recorded; periodontitis patients received non-surgical periodontal treatment, and GCF and saliva samples were obtained at baseline and one month after treatment. TGF-β, Smad6, and Smad7 were determined by ELISA.

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Conditions studied

  • Periodontitis
  • Treatment Adherence

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Keywords

  • Smad
  • Periodontitis
  • Gingival crevicular fluid
  • Saliva
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 40 is below the median of 90 across 428 observational studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Bulent Ecevit University is the lead sponsor of 45 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

  1. group (Control): Periodontally and systemically healthy
  2. group: Systemically healthy and periodontitis

Inclusion criteria

  • Have at least 20 natural teeth, excluding third molars.
  • Periodontitis patients had at least two non-adjacent sites per quadrant with probing depth (PD) ≥ 5 mm and clinical attachment level (CAL) ≥ 5 mm with gingival inflammation, and alveolar bone loss affecting >30% of the teeth, as detected on clinical and radiographical examinations.
  • Periodontally healthy control group had no sign of gingival inflammation, no PD > 3mm and no evidence of attachment or bone loss

Exclusion criteria

Exclusion Criteria:

  • History of systemic disease.
  • Regular use of any drugs which can effect the immune system or inflammatory response in the 6 months preceding the start of the study.
  • Periodontal treatment during last 6 months that could affect periodontal status.
  • Smoking.
  • History of radiotherapy or chemotherapy.
  • Current pregnancy, lactation or menopause.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (actual)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • Control

    Diagnostic Test: Periodontally healthy group

  • Periodontitis

    Diagnostic Test: Periodontitis

Interventions

  • Diagnostic testPeriodontally healthy group

    probing pocket depth (PPD)≤ 3 mm (presence of normal gingival sulcus), bleeding on probing (BOP) \< 10%, clinical absence of periodontal inflammation, radiological bone loss, and any prior periodontal disease, additionally presence of anatomically intact periodontium

  • Diagnostic testPeriodontitis

    : interdental clinical attachment level (CAL) ≥ 5 mm and PPD ≥ 6 mm on at least two non-adjacent teeth, bone loss involving the middle or apical third of the root radiographically, moderate ridge defect and ≥30% of teeth

06

What researchers measure

Primary outcomes

  1. TGF-β, Smad6, and Smad7 levels

    the levels of TGF-β, Smad6, and Smad7 in gingival crevicular fluid (GCF) and saliva

    Time frame: baseline

Secondary outcomes

  1. TGF-β, Smad6, and Smad7 levels

    the levels of TGF-β, Smad6, and Smad7 in gingival crevicular fluid (GCF) and saliva before and after non-surgical periodontal treatment.

    Time frame: baseline and 1st month after treatment

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Study locations

1 site
  • Figen Öngöz Dede
    Ordu, 52100, Turkey
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04846166
Lead sponsor
Bulent Ecevit University
Responsible party
Figen Öngöz Dede (T.C. ORDU ÜNİVERSİTESİ, Bulent Ecevit University) — Principal investigator
First posted
Apr 15, 2021
Start date
Aug 1, 2019
Primary completion
Mar 1, 2020
Completion
Mar 1, 2020
Last update
Apr 19, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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