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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periodontitis Group | Experimental | Participants with Stage III Grade B/C periodontitis. At baseline, clinical periodontal measurements are recorded, and serum and gingival crevicular fluid samples are collected. All participants receive non-surgical periodontal therapy consisting of Scaling and Root Planing (SRP). Follow-up visits are conducted at 6 weeks and 3 months post-treatment for repeated clinical assessments and sample collection to evaluate changes in biochemical markers (GPNMB, TGF-β1, RANKL, and OPG). |
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| Healthy Control Group | No Intervention | Periodontally healthy individuals. Participants undergo a single clinical periodontal examination and provide serum and gingival crevicular fluid samples at the baseline visit. This group serves as a reference for baseline biochemical marker levels. No therapeutic intervention is performed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scaling and Root Planing (SRP) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gingival Crevicular Fluid (GCF) Glycoprotein Non-Metastatic B (GPNMB) Concentration | 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). | Baseline, 6 weeks, and 3 months post-treatment. |
| Change in Serum Glycoprotein Non-Metastatic B (GPNMB) Concentration | 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. | Baseline, 6 weeks post-treatment, and 3 months post-treatment. |
| Change in Gingival Crevicular Fluid (GCF) Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) Concentration | 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. | Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment. |
| Change in Serum Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) Concentration | 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. | Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment. |
| Change in Gingival Crevicular Fluid (GCF) Osteoprotegerin (OPG) Concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Probing Pocket Depth (PPD) | 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. | Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment. |
| Change in Clinical Attachment Loss (CAL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi | Ankara | 06010 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D003966 | Camurati-Engelmann Syndrome |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010009 | Osteochondrodysplasias |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
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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). |
| Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment. |
| Change in Serum Osteoprotegerin (OPG) Concentration | 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. | Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment. |
| Change in Gingival Crevicular Fluid (GCF) Transforming Growth Factor beta 1 (TGF-β1) Concentration | 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. | Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment. |
| Change in Serum Transforming Growth Factor beta 1 (TGF-β1) Concentration | 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). | 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. |
| Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment. |
| Change in Plaque Index (PI) | Plaque Index (PI) will be used to assess the amount of plaque on the tooth surfaces to evaluate oral hygiene status. | Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment. |
| Change in Gingival Index (GI) | Gingival Index (GI) will be used to assess the severity of gingival inflammation based on color, consistency, and bleeding tendency. | Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment. |
| D001848 |
| Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |