- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07243145
Analysis of the Impact of Contemporary Subgingival Debridement Techniques on Immunological Biomarkers in Gingival Crevicular Fluid
AIM: This prospective clinical study aimed to evaluate the efficacy of two distinct non-surgical periodontal therapy modalities in patients diagnosed with Stage 1 and Stage 2 periodontitis.
METHOD: The study comprised 80 nonsmoking, systemically healthy volunteers. Patients were divided into two groups at random: the Guided Biofilm Therapy (GBT) group and the convetional therapy group, which included Gracey curette and an ultrasonic device. All patients were assessed before and one and three months after therapy for clinical characteristics like pocket depth, Gingival Index (GI), Plaque Index (PI), Bleeding on Probing Index (BOP), and the levels of IL-1β, IL-10, TNF-α, and MMP-8 in gingival crevicular fluid (GCF).
RESULTS: ... CONCLUSION:...
Study Overview
Status
Detailed Description
AIM: This prospective clinical study aimed to evaluate the efficacy of two distinct non-surgical periodontal therapy modalities in patients diagnosed with Stage 1 and Stage 2 periodontitis.
METHOD: The study comprised 80 nonsmoking, systemically healthy volunteers. Patients were divided into two groups at random: the Guided Biofilm Therapy (GBT) group and the convetional therapy group, which included Gracey curette and an ultrasonic device. All patients were assessed before and one and three months after therapy for clinical characteristics like pocket depth, Gingival Index (GI), Plaque Index (PI), Bleeding on Probing Index (BOP), and the levels of IL-1β, IL-10, TNF-α, and MMP-8 in gingival crevicular fluid (GCF).
RESULTS: ... CONCLUSION:...
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Niğde, Turkey (Türkiye)
- Nigde Omer Halisdemir University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Patients who applied to Niğde Ömer Halisdemir University Faculty of Dentistry Periodontics Clinic between 15.10.2024 and 15.12.2024 for periodontal treatment, volunteered to participate in the study and met the following criteria were included in the study. Written consent was obtained from volunteer patients for the research.
The patients were evaluated by a single periodontologist (SND), and patients with mild to moderate periodontitis (Stage 1-2) who required supragingival and subgingival calculus removal were included in the study.
Description
Inclusion Criteria:
- Systemically healthy (no known chronic diseases)
- Completed periodontal diagnostic data (Gingival Index, Plaque Index, Periodontal pocket depths, Attachment loss, Radiological data, and Bone loss data)
- Did not take anti-inflammatory drugs in the previous month
- Volunteered to participate with Stage 1-2 periodontitis.
Exclusion Criteria:
- Patients with systemic diseases
- Pregnant or lactating patients
- Smokers
- Patients who did not wish to participate in the study were excluded
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
1.Group: The Conventional Treatment
Cavitron and Gracey curette (the standard technique) was utilized for subgingival debridement
|
|
2. group: Guided biofilm therapy
Subgingival debridement was carried out using the GBT approach, which involved following the protocol's directions properly.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gingival index
Time Frame: baseline
|
All teeth are evaluated on 4 surfaces (distal, buccal, mesial, lingual) and the average is calculated. 0= Normal gingiva
|
baseline
|
|
Gingival index
Time Frame: 1st month
|
All teeth are evaluated on 4 surfaces (distal, buccal, mesial, lingual) and the average is calculated. 0= Normal gingiva
|
1st month
|
|
Gingival index
Time Frame: 3rd month
|
All teeth are evaluated on 4 surfaces (distal, buccal, mesial, lingual) and the average is calculated. 0= Normal gingiva
|
3rd month
|
|
IL-1β
Time Frame: baseline
|
A single specialist physician took GCF measurements at baseline, one month, and three months from the tooth with the deepest pocket identified at baseline before treatment in patients with periodontitis. In short, the region was isolated using cotton pads, and the plaque was removed using cotton pellets. After that, 20 cm of mild air drying was applied. Strips of absorbent paper (Periopaper®, Proflow Inc., Amityville, NY, USA) were used to obtain GCF samples. The strips were positioned for 30 seconds after being carefully inserted into the gingival sulcus/periodontal pocket until a small amount of resistance was felt. Strips tainted with blood were thrown away. Before being used for laboratory testing, each subject's strips were gathered, combined, and kept at -80 °C (Ultra Low-Temperature Freezer, New Brunswick Scientific). As directed by the manufacturer, enzyme-linked immunosorbent assay (ELISA) kits were used to measure the levels of IL-1β, TNF-alpha, IL-10, and MMP-8 in GCF |
baseline
|
|
IL-1β
Time Frame: 1st month
|
A single specialist physician (SOB) took GCF measurements at baseline, one month, and three months from the tooth with the deepest pocket identified at baseline before treatment in patients with periodontitis. In short, the region was isolated using cotton pads, and the plaque was removed using cotton pellets. After that, 20 cm of mild air drying was applied. Strips of absorbent paper (Periopaper®, Proflow Inc., Amityville, NY, USA) were used to obtain GCF samples. The strips were positioned for 30 seconds after being carefully inserted into the gingival sulcus/periodontal pocket until a small amount of resistance was felt. Strips tainted with blood were thrown away. Before being used for laboratory testing, each subject's strips were gathered, combined, and kept at -80 °C (Ultra Low-Temperature Freezer, New Brunswick Scientific). As directed by the manufacturer, enzyme-linked immunosorbent assay (ELISA) kits were used to measure the levels of IL-1β, TNF-alpha, IL-10, and MMP-8 in GCF |
1st month
|
|
IL-1β
Time Frame: 3rd month
|
A single specialist physician (SOB) took GCF measurements at baseline, one month, and three months from the tooth with the deepest pocket identified at baseline before treatment in patients with periodontitis. In short, the region was isolated using cotton pads, and the plaque was removed using cotton pellets. After that, 20 cm of mild air drying was applied. Strips of absorbent paper (Periopaper®, Proflow Inc., Amityville, NY, USA) were used to obtain GCF samples. The strips were positioned for 30 seconds after being carefully inserted into the gingival sulcus/periodontal pocket until a small amount of resistance was felt. Strips tainted with blood were thrown away. Before being used for laboratory testing, each subject's strips were gathered, combined, and kept at -80 °C (Ultra Low-Temperature Freezer, New Brunswick Scientific). As directed by the manufacturer, enzyme-linked immunosorbent assay (ELISA) kits were used to measure the levels of IL-1β, TNF-alpha, IL-10, and MMP-8 in GCF |
3rd month
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/87
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Periodontal Inflammation
-
University of ChileRecruitingPeriodontitis | Periodontal Diseases | Gingival Diseases | Periodontal Attachment Loss | Periodontal InflammationChile
-
British University In EgyptCompletedPeriodontal Diseases | Periodontal Pocket | Periodontal Attachment Loss | Periodontal InflammationEgypt
-
Krishnadevaraya College of Dental Sciences & HospitalCompletedPeriodontitis | Periodontal Attachment Loss | Periodontal Inflammation | Pocket, PeriodontalIndia
-
University of SalamancaCompletedPeriodontal Disease | Periodontal InflammationSpain
-
University of BernRecruitingPeriodontitis | Periodontal Attachment Loss | Periodontal InflammationSwitzerland
-
Medipol UniversityNot yet recruitingPeriodontal Diseases InflammationTurkey (Türkiye)
-
Inonu UniversityActive, not recruitingPeriodontitis | Periodontal InflammationTurkey (Türkiye)
-
Fundacion Clinica PardinasUniversidade da Coruña; University Hospital A CoruñaCompletedPeriodontitis | Periodontal Diseases | Periodontal Attachment Loss | Periodontal InflammationSpain
-
University of BeykentCompletedPeriodontal Diseases | Periodontal Attachment Loss | Periodontal Inflammation | Periodontal Disease, AVDC Stage 3 | Periodontal Disease, AVDC Stage 4Turkey
-
Queen Mary University of LondonGeistlich Pharma AGRecruitingPeriodontitis | Wound Heal | Periodontal Pocket | Periodontal Attachment Loss | Periodontal InflammationUnited Kingdom