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# Brief Summary (Word count: 198)
This combined observational and interventional study investigates salivary amino acid profiles and their connections to periodontal conditions, as well as how these substances change after standard non-surgical gum treatment. It recruits adults aged 20 to 50, including healthy volunteers, people with gingivitis and periodontitis. The study is approved by the institutional ethics committee with the ID WCHSIRB-D-2023-370. The main questions it aims to answer are:
Do salivary free amino acid levels differ across people with healthy gums, gingivitis and periodontitis? Are changes in salivary branched-chain amino acids related to improved gum health after treatment?
Researchers compare three groups in the observational part and track periodontitis patients to assess treatment effects. All participants go through eligibility screening, full periodontal checks and morning saliva collection. 45 participants complete only one baseline visit. Another 32 periodontitis patients receive standard therapy and return for re-examinations at 6 and 12 weeks. Saliva samples are tested for amino acid concentrations. Statistical analysis will explore the correlation between salivary markers and gum conditions. The results may aid clinical evaluation and management of periodontal diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Surgical Periodontal Therapy Group | Experimental | Participants in this experimental arm receive standardized non-surgical periodontal therapy. The treatment includes personalized oral hygiene instruction and quadrant-wise scaling and root planing, performed once weekly following the European Federation of Periodontology (EFP) clinical practice guidelines. Post-treatment follow-up assessments, including full-mouth periodontal examinations and unstimulated saliva collection, are scheduled at 6 weeks and 12 weeks after therapy completion to evaluate clinical outcomes and salivary amino acids changes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-surgical periodontal therapy | Procedure | Standardized non-surgical periodontal therapy, including personalized oral hygiene instruction and quadrant-wise scaling and root planing, is provided once weekly following the European Federation of Periodontology (EFP) clinical practice guidelines. The goal is to remove supra- and subgingival plaque and calculus to reduce periodontal inflammation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Salivary Branched-Chain Amino Acid (BCAA) Concentrations from Baseline to 12 Weeks Post-Treatment | Salivary concentrations of branched-chain amino acids (BCAAs: leucine, isoleucine, valine) will be measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS) at three time points: baseline (pre-treatment), 6 weeks post-treatment, and 12 weeks post-treatment. The primary outcome is the mean change in BCAA levels from baseline to the 12-week follow-up, reflecting the long-term metabolic response to non-surgical periodontal therapy. | Baseline (pre-treatment) and 12 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Probing Depth (PD) from Baseline to 12 Weeks Post-Treatment | Probing depth (PD) will be measured at six sites per tooth using a calibrated UNC-15 periodontal probe at baseline and 12 weeks post-treatment. The mean change in PD from baseline to 12 weeks will be calculated to assess the improvement in periodontal pocket depth after therapy. | Baseline (pre-treatment) and 12 weeks post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Stomatology, Sichuan University | Chengdu | Sichuan | 610041 | China |
Individual participant data (IPD) will not be shared with other researchers due to restrictions from the institutional review board (IRB) and hospital data management policies, which are designed to protect patient privacy and confidentiality. The aggregated results of this study will be published in peer-reviewed journals.
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| Change in Mean Clinical Attachment Level (CAL) from Baseline to 12 Weeks Post-Treatment | Clinical attachment level (CAL) will be measured at six sites per tooth using a calibrated periodontal probe at baseline and 12 weeks post-treatment. The mean change in CAL from baseline to 12 weeks will be evaluated to reflect improvements in periodontal attachment support. | Baseline (pre-treatment) and 12 weeks post-treatment |
| Change in Bleeding on Probing Percentage (BOP%) from Baseline to 12 Weeks Post-Treatment | Bleeding on probing (BOP) will be recorded as present or absent at six sites per tooth during periodontal examinations at baseline and 12 weeks post-treatment. The percentage of bleeding sites (BOP%) will be calculated, and the change from baseline to 12 weeks will be analyzed to assess reductions in periodontal inflammation. | Baseline (pre-treatment) and 12 weeks post-treatment |
| Change in Mean Probing Depth (PD) from Baseline to 6 Weeks Post-Treatment | Probing depth (PD) will be measured at six sites per tooth at baseline and 6 weeks post-treatment. The mean change in PD from baseline to 6 weeks will be analyzed to evaluate the early clinical response to non-surgical periodontal therapy. | Baseline (pre-treatment) and 6 weeks post-treatment |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D005891 | Gingivitis |
| D010510 | Periodontal Diseases |
| D017622 | Periodontal Attachment Loss |
| D010514 | Periodontal Pocket |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D055093 | Periodontal Atrophy |
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