I-Smads in Periodontitis

NCT ID: NCT04846166

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-03-01

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control

Periodontally healthy group

Intervention Type: 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

Periodontitis

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bulent Ecevit University

OTHER

Sponsor Role: lead

Responsible Party

Figen Öngöz Dede

T.C. ORDU ÜNİVERSİTESİ

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Figen Öngöz Dede

Ordu, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

B-1921

Identifier Type: -

Identifier Source: org_study_id