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NCT Number: NCT04846166

I-Smads in Periodontitis

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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Key information

Conditions

Periodontitis Behavior Health Behavior Mouth Diseases Periodontal Diseases Stomatognathic Diseases Treatment Adherence Treatment Adherence and Compliance

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Figen Öngöz Dede

Ordu, 52100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Periodontally healthy group

Diagnostic Test

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

Periodontitis

Diagnostic Test

: 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

Primary outcomes

  1. TGF-β, Smad6, and Smad7 levels

    Time frame: baseline

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

Secondary outcomes

  1. TGF-β, Smad6, and Smad7 levels

    Time frame: baseline and 1st month after treatment

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

Sponsors and collaborators

Lead sponsor

Bulent Ecevit University

Other

Registry information

Official study title

Role of Inhibitor SMADs in Stage 3 Grade B Periodontitis Before and After Periodontal Treatment

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 15, 2021
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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