I-Smads in Periodontitis

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04846166
• Other study ID #: B-1921
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2021
• Source: Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis
• Treatment Adherence

Intervention

Diagnostic Test:
• Periodontally 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
• Periodontitis
: 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

Locations

Country	Name	City	State
Turkey	Figen Öngöz Dede	Ordu

Sponsors (1)

Lead Sponsor	Collaborator
Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TGF-ß, Smad6, and Smad7 levels	the levels of TGF-ß, Smad6, and Smad7 in gingival crevicular fluid (GCF) and saliva	baseline
Secondary	TGF-ß, Smad6, and Smad7 levels	the levels of TGF-ß, Smad6, and Smad7 in gingival crevicular fluid (GCF) and saliva before and after non-surgical periodontal treatment.	baseline and 1st month after treatment