An interventional study of Non-surgical Periodontal Therapy (Scaling and Root Planing) and Saliva Collection in Periodontal Disease and Chronic Periodontitis (Disorder), sponsored by Ömer Faruk Okumuş. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by Ömer Faruk Okumuş · Not applicable, Interventional, and Basic science
Periodontitis (gum inflammation) is a common disease worldwide. This study aims to investigate a novel biomarker, a protein called Mitofusin-1 (Mfn1), in saliva that may be associated with the severity of periodontitis and response to treatment. The study will include periodontally healthy individuals, individuals with mild to severe periodontitis, and smokers with severe periodontitis. Participants will receive saliva samples and undergo clinical periodontal examinations. Individuals with periodontitis will receive standard periodontal treatment, and changes in Mfn1 levels will be assessed 3 months after treatment. The study is expected to shed light on the potential utility of Mfn1 as a marker in the diagnosis and follow-up of periodontitis.
830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.
This study's planned enrollment of 104 is above the median of 45 across 530 interventional studies indexed under Periodontal Diseases.
Browse Periodontal Diseases studies →Ömer Faruk Okumuş is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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For Healthy Control Group:
No clinical attachment loss. Probing depth ≤ 3 mm. No radiographic evidence of bone loss. Low gingival and plaque index scores.
For Mild Periodontitis Group:
Diagnosed with Stage I or II periodontitis according to the 2018 AAP/EFP classification.
Clinical attachment loss of 1-4 mm. Radiographic bone loss of ≤15-33%. Non-smoker.
For Severe Periodontitis Group:
Diagnosed with Stage III or IV periodontitis according to the 2018 AAP/EFP classification.
Clinical attachment loss ≥ 5 mm. Radiographic bone loss to the mid-advanced level of the root. Non-smoker.
For Severe Periodontitis with Smoking Group:
Meets all criteria for the Severe Periodontitis Group. Regular smoker (at least 10 cigarettes per day for a minimum of 5 years).
Exclusion Criteria:
Periodontally healthy individuals with no clinical attachment loss, probing depth ≤3 mm, no radiographic bone loss, and low gingival and plaque index scores.
Other: Saliva Collection
Non-smoking individuals diagnosed with Stage I-II periodontitis according to the AAP/EFP 2018 classification, with clinical attachment loss of 1-4 mm and ≤15-33% radiographic bone loss.
Procedure: Non-surgical Periodontal Therapy (Scaling and Root Planing) · Other: Saliva Collection
Non-smoking individuals diagnosed with Stage III-IV periodontitis according to the AAP/EFP 2018 classification, with clinical attachment loss ≥5 mm and radiographic bone loss to the mid-advanced level of the root.
Procedure: Non-surgical Periodontal Therapy (Scaling and Root Planing) · Other: Saliva Collection
Individuals who meet the criteria for the Severe Periodontitis Group and are also regular smokers (at least 10 cigarettes per day for a minimum of 5 years).
Procedure: Non-surgical Periodontal Therapy (Scaling and Root Planing) · Other: Saliva Collection
A standard periodontal treatment procedure that involves the removal of dental plaque and calculus (tartar) from the tooth surfaces and root pockets. This is followed by root planing to smooth the root surfaces, allowing the gingiva to heal and reattach to the tooth.
Collection of unstimulated whole saliva. Participants will be asked to allow saliva to pool in the floor of the mouth and then passively drool into a sterile collection tube. A total of 1.5 ml of saliva will be collected from each participant.
Salivary Mitofusin-1 (Mfn1) Concentration at Baseline
Mfn1 protein concentration in saliva measured using ELISA (ng/mL) at baseline in each study group.
Time frame: Baseline
Change in Salivary Mfn1 Concentration After Periodontal Therapy
Difference in salivary Mfn1 concentration (ng/mL) measured using ELISA at baseline and 3 months after non-surgical periodontal therapy in the periodontitis groups.
Time frame: Baseline and 3 months
Salivary Glutathione Peroxidase (GPx) Concentration
GPx enzyme activity measured in saliva by spectrophotometric colorimetric assay (U/L).
Time frame: Baseline
Salivary 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) Concentration
8-OHdG concentration measured in saliva using ELISA (ng/mL).
Time frame: Baseline
Correlation Between Salivary Mfn1 Concentration and Probing Depth (PD)
Correlation coefficient (r) between salivary Mitofusin-1 (Mfn1) concentration measured by ELISA (ng/mL) and probing depth measured with a manual periodontal probe (mm).
Time frame: Baseline
Correlation Between Salivary Mfn1 Concentration and Clinical Attachment Level (CAL)
Correlation coefficient (r) between salivary Mitofusin-1 (Mfn1) concentration measured by ELISA (ng/mL) and clinical attachment level measured with a manual periodontal probe (mm).
Time frame: Baseline
Correlation Between Salivary Mfn1 Concentration and Plaque Index (PI)
Correlation coefficient (r) between salivary Mitofusin-1 (Mfn1) concentration measured by ELISA (ng/mL) and plaque index assessed using the Silness-Löe Plaque Index (%).
Time frame: Baseline
Correlation Between Salivary Mfn1 Concentration and Gingival Index (GI)
Correlation coefficient (r) between salivary Mitofusin-1 (Mfn1) concentration measured by ELISA (ng/mL) and gingival index assessed using the Löe-Silness Gingival Index (score).
Time frame: Baseline
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Ömer Faruk Okumuş