Periodontitis (Stage 3)
Conditions
Keywords
TGF-beta1, GPNMB, RANKL, OPG, Periodontitis, non-surgical periodontal treatment
Brief summary
The goal of this study is to learn how a standard treatment called Scaling and Root Planing (SRP) affects specific biochemical markers in people with advanced gum disease (periodontitis). Periodontitis is a chronic condition that can lead to tooth loss. The main focus is to investigate a marker called Glycoprotein Non-Metastatic B (GPNMB). This is the first study to examine GPNMB levels in both the serum and the gingival crevicular fluid of people with this condition. The study aims to answer these main questions: How do GPNMB levels change after the Scaling and Root Planing treatment? How does GPNMB relate to other markers that control bone health and healing, such as TGF-β1, RANKL, and Osteoprotegerin? Researchers will compare 28 participants with advanced gum disease (Stage III Grade B/C) to 28 participants with healthy gums to see how these markers differ. Participants in the gum disease group will: Provide samples for laboratory analysis at the start of the study. Receive the standard mechanical treatment of their teeth and roots (Scaling and Root Planing). Return for follow-up visits 6 weeks and 3 months after treatment to provide new samples and have their gum health checked.
Interventions
PROCEDUREScaling and Root Planing (SRP)
A standard non-surgical mechanical treatment that involves the removal of plaque and calculus from the teeth and root surfaces using ultrasonic devices and hand instruments.
Sponsors
Saglik Bilimleri Universitesi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Systemically healthy individuals * Individuals diagnosed with Stage III Grade B or Grade C periodontitis (for the periodontitis group) * Periodontally healthy individuals (for the healthy control group) * Participants aged 18 years and older
Exclusion criteria
* Individuals who have received periodontal treatment within the last 6 months * Individuals who have used antibacterial drugs within the last 6 months * Individuals with any systemic disease * Individuals who use medications on a regular basis * Current smokers * Pregnant individuals * Participants under the age of 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gingival Crevicular Fluid (GCF) Glycoprotein Non-Metastatic B (GPNMB) Concentration | Baseline, 6 weeks, and 3 months post-treatment. | Concentration of GPNMB in gingival crevicular fluid samples measured by Enzyme-Linked Immunosorbent Assay (ELISA). Results will be expressed in picograms per microliter (pg/µL) to evaluate the local biochemical response following scaling and root planing (SRP). |
| Change in Serum Glycoprotein Non-Metastatic B (GPNMB) Concentration | Baseline, 6 weeks post-treatment, and 3 months post-treatment. | Concentration of GPNMB in serum samples measured by Enzyme-Linked Immunosorbent Assay (ELISA) to evaluate the systemic biochemical response. The results will be quantified and reported in picograms per milliliter (pg/mL) to evaluate the change in mean concentration values across the specified measurement intervals. |
| Change in Gingival Crevicular Fluid (GCF) Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) Concentration | Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment. | Concentration of RANKL in gingival crevicular fluid samples measured via ELISA to assess local bone resorption activity. The data will be quantified in picograms per microliter (pg/µL) at baseline and post-treatment intervals. |
| Change in Serum Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) Concentration | Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment. | Concentration of RANKL in serum samples measured by ELISA to evaluate the systemic bone resorption activity. The results will be quantified and reported in picograms per milliliter (pg/mL) to evaluate the change in mean concentration values across the specified measurement intervals following periodontal therapy. |
| Change in Gingival Crevicular Fluid (GCF) Osteoprotegerin (OPG) Concentration | Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment. | Concentration of OPG in gingival crevicular fluid samples measured by ELISA to assess the local bone-protective response. The results will be quantified and reported in picograms per microliter (pg/µL) to evaluate the change in mean concentration values across the specified measurement intervals following scaling and root planing (SRP). |
| Change in Serum Osteoprotegerin (OPG) Concentration | Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment. | Concentration of OPG in serum samples measured by ELISA to evaluate the systemic bone-protective response. Measurement values will be reported in picograms per milliliter (pg/mL) to compare the changes in mean concentration values across the specified measurement intervals following periodontal therapy. |
| Change in Gingival Crevicular Fluid (GCF) Transforming Growth Factor beta 1 (TGF-β1) Concentration | Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment. | Concentration of TGF-β1 in gingival crevicular fluid samples measured by Enzyme-Linked Immunosorbent Assay (ELISA). This analysis evaluates the local anti-inflammatory response and tissue healing following scaling and root planing (SRP). The results will be quantified and reported in picograms per microliter (pg/µL) to evaluate the change in mean concentration values across the specified measurement intervals. |
| Change in Serum Transforming Growth Factor beta 1 (TGF-β1) Concentration | Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment. | Concentration of TGF-β1 in serum samples measured by ELISA to evaluate the systemic anti-inflammatory response. Measurement values will be reported in picograms per milliliter (pg/mL) to compare the changes before and after scaling and root planing (SRP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing Pocket Depth (PPD) | Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment. | Probing Pocket Depth (PPD) will be measured at six sites per tooth using a Williams periodontal probe to evaluate the depth of the periodontal pockets. |
| Change in Clinical Attachment Loss (CAL) | Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment. | Clinical Attachment Loss (CAL) will be measured at six sites per tooth using a Williams periodontal probe to assess the level of periodontal tissue attachment. |
| Change in Plaque Index (PI) | Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment. | Plaque Index (PI) will be used to assess the amount of plaque on the tooth surfaces to evaluate oral hygiene status. |
| Change in Gingival Index (GI) | Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment. | Gingival Index (GI) will be used to assess the severity of gingival inflammation based on color, consistency, and bleeding tendency. |
Countries
Turkey (Türkiye)
Outcome results
None listed