Analysis of the Impact of Contemporary Subgingival Debridement Techniques on Immunological Biomarkers in Gingival Crevicular Fluid

NCT07243145 | Completed

• 1 other identifier: 2023/87
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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:...

Conditions

Peridontal Disease; Periodontal Inflammation; Periodontitis, Adult

Keywords

periodontitis; guided biofilm therapy; non surgical periodontal treatment; Gingival Crevicular Fluid

Outcome Measures

Primary Outcomes (6)

• Gingival index

  All teeth are evaluated on 4 surfaces (distal, buccal, mesial, lingual) and the average is calculated. 0= Normal gingiva 1. Mild inflammation - minor color change, minor edema. No bleeding after probing. 2. Moderate inflammation - redness, edema and shine. Bleeding after probing. 3. Severe inflammation - significant redness and edema. Ulceration. Spontaneous bleeding tendency.

  baseline

• Gingival index

  All teeth are evaluated on 4 surfaces (distal, buccal, mesial, lingual) and the average is calculated. 0= Normal gingiva 1. Mild inflammation - minor color change, minor edema. No bleeding after probing. 2. Moderate inflammation - redness, edema and shine. Bleeding after probing. 3. Severe inflammation - significant redness and edema. Ulceration. Spontaneous bleeding tendency.

  1st month

• Gingival index

  All teeth are evaluated on 4 surfaces (distal, buccal, mesial, lingual) and the average is calculated. 0= Normal gingiva 1. Mild inflammation - minor color change, minor edema. No bleeding after probing. 2. Moderate inflammation - redness, edema and shine. Bleeding after probing. 3. Severe inflammation - significant redness and edema. Ulceration. Spontaneous bleeding tendency.

  3rd month

• IL-1β

  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

  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

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with systemic diseases
• Pregnant or lactating patients
• Smokers
• Patients who did not wish to participate in the study were excluded

Sponsors & Collaborators

• Selcen Ozcan Bulut: lead
• Nigde Omer Halisdemir University: collaborator
• Niğde Ömer Halisdemir University: collaborator

Study Sites (1)

Nigde Omer Halisdemir University

Niğde, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nigde Omer Halisdemir University

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: November 21, 2025
• Study Start: October 15, 2024
• Primary Completion: April 15, 2025
• Study Completion: May 15, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

TU (1)