Erzincan Binali Yıldırım University Faculty of Dentistry
Erzincan, 24002, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07262606
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Erzincan, 24002, Turkey (Türkiye)
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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.
Time frame: Baseline
Mfn1 protein concentration in saliva measured using ELISA (ng/mL) at baseline in each study group.
Time frame: Baseline and 3 months
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
GPx enzyme activity measured in saliva by spectrophotometric colorimetric assay (U/L).
Time frame: Baseline
8-OHdG concentration measured in saliva using ELISA (ng/mL).
Time frame: Baseline
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 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 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 coefficient (r) between salivary Mitofusin-1 (Mfn1) concentration measured by ELISA (ng/mL) and gingival index assessed using the Löe-Silness Gingival Index (score).
Contact information is provided by the study sponsor or research team.
Ömer Faruk Okumuş
Other
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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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