- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04846166
I-Smads in Periodontitis
April 15, 2021 updated by: Figen Öngöz Dede, Bulent Ecevit University
Role of Inhibitor SMADs in Stage 3 Grade B Periodontitis Before and After Periodontal Treatment
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ordu, Turkey, 52100
- Figen Öngöz Dede
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
- group (Control): Periodontally and systemically healthy
- group: Systemically healthy and periodontitis
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TGF-β, Smad6, and Smad7 levels
Time Frame: baseline
|
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
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.
|
baseline and 1st month after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2019
Primary Completion (Actual)
March 1, 2020
Study Completion (Actual)
March 1, 2020
Study Registration Dates
First Submitted
April 12, 2021
First Submitted That Met QC Criteria
April 12, 2021
First Posted (Actual)
April 15, 2021
Study Record Updates
Last Update Posted (Actual)
April 19, 2021
Last Update Submitted That Met QC Criteria
April 15, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-1921
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Periodontitis
-
Azienda Socio Sanitaria Territoriale degli Spedali...Università degli Studi di FerraraCompletedPeriodontitis, Aggressive | Periodontitis, AdultItaly
-
Panineeya Mahavidyalaya Institute of Dental Sciences...Research Institute for Genetic and Human TherapyUnknownGeneralized Adult Periodontitis
-
Asem Mohammed Kamel AliCompletedMolar-incisor Pattern Grade C Periodontitis ( Localized Aggressive Periodontitis) | Generalized Grade C Periodontitis (Generalized Aggressive Periodontitis)Egypt
-
Columbia UniversityCompletedPeriodontal Diseases | Generalized Moderate Chronic Periodontitis | Generalized Severe Chronic PeriodontitisUnited States
-
Postgraduate Institute of Dental Sciences RohtakUnknownChronic Apical PeriodontitisIndia
-
University of SienaNot yet recruitingPeriodontitis, AdultItaly
-
Lithuanian University of Health SciencesCompleted
-
Louisiana State University Health Sciences Center...CompletedPeriodontitis, AdultUnited States
-
University of BergenCompletedPeriodontitis | Adult Periodontitis
-
Cairo UniversityUnknownPeriodontitis, AdultEgypt
Clinical Trials on Periodontally healthy group
-
Bulent Ecevit UniversityCompleted
-
Bulent Ecevit UniversityCompletedPeriodontitis
-
Somogy Megyei Kaposi Mór Teaching HospitalUniversity of GroningenCompletedHealthy | Parkinson Disease | Movement Disorders | ConditionHungary
-
Damascus UniversityCompletedCrowded Teeth | Malocclusion, Angle Class ISyrian Arab Republic
-
Damascus UniversityCompletedCrowding of Anterior Mandibular TeethSyrian Arab Republic
-
University of Sao PauloUnknown
-
Kırıkkale UniversityCompletedSmartphone Addiction, Temporomandibular Joint DysfunctionTurkey
-
Hvidovre University HospitalCompleted
-
Thomas Jefferson UniversityActive, not recruiting
-
Temple UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedObesity | Weight Loss | Pregnancy | BehavioralUnited States