I-Smads in Periodontitis

Study Overview
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Brief Summary
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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.

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

Conditions
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Treatment Adherence, Periodontitis

Intervention / Treatment
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* Diagnostic Test: Periodontally healthy group
* Diagnostic Test: Periodontitis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br> | Diagnostic Test: Periodontally healthy group<br>* 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<br>|
| Periodontitis<br> | Diagnostic Test: Periodontitis<br>* : 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TGF-β, Smad6, and Smad7 levels | the levels of TGF-β, Smad6, and Smad7 in gingival crevicular fluid (GCF) and saliva | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline and 1st month after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smad, Periodontitis, Gingival crevicular fluid, Saliva