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Completed

NCT Number: 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:...

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Key information

Conditions

Peridontal Disease Chronic Disease Chronic Periodontitis Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontal Inflammation Periodontitis Periodontitis, Adult Stomatognathic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nigde Omer Halisdemir University

Niğde, Turkey (Türkiye)

About this study

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:...

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Gingival index

    Time frame: baseline

    All teeth are evaluated on 4 surfaces (distal, buccal, mesial, lingual) and the average is calculated.

    0= Normal gingiva

    • Mild inflammation - minor color change, minor edema. No bleeding after probing.
    • Moderate inflammation - redness, edema and shine. Bleeding after probing.
    • Severe inflammation - significant redness and edema. Ulceration. Spontaneous bleeding tendency.

  2. 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

    • Mild inflammation - minor color change, minor edema. No bleeding after probing.
    • Moderate inflammation - redness, edema and shine. Bleeding after probing.
    • Severe inflammation - significant redness and edema. Ulceration. Spontaneous bleeding tendency.

  3. 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

    • Mild inflammation - minor color change, minor edema. No bleeding after probing.
    • Moderate inflammation - redness, edema and shine. Bleeding after probing.
    • Severe inflammation - significant redness and edema. Ulceration. Spontaneous bleeding tendency.

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Selcen Ozcan Bulut

Other

Collaborators

  • Nigde Omer Halisdemir University
  • Niğde Ömer Halisdemir University

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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