I-Smads in Periodontitis

NCT04846166 | Completed

• 1 other identifier: B-1921
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontitis; Treatment Adherence

Keywords

Smad; Periodontitis; Gingival crevicular fluid; Saliva

Outcome Measures

Primary Outcomes (1)

• TGF-β, Smad6, and Smad7 levels

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

  baseline

Secondary Outcomes (1)

• TGF-β, Smad6, and Smad7 levels

  baseline and 1st month after treatment

Study Arms (2)

Control

Diagnostic Test: Periodontally healthy group

Periodontitis

Diagnostic Test: Periodontitis

Interventions

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

Control

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

Periodontitis

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bulent Ecevit University: lead

Study Sites (1)

Figen Öngöz Dede

Ordu, 52100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: T.C. ORDU ÜNİVERSİTESİ

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 15, 2021
• Study Start: August 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

TU (1)