- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07775378
Boron Levels, Oxidative Stress, and Inflammation in Periodontitis
Evaluation of the Relationship Between Boron Levels and Oxidative Stress, Antioxidant Defense, and Inflammatory Markers in Individuals With Periodontitis
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Periodontitis is a chronic inflammatory disease characterized by the destruction of the tooth-supporting tissues and is associated with an imbalance between oxidative stress and antioxidant defense mechanisms. Boron is a trace element that has been suggested to have potential roles in antioxidant and inflammatory processes; however, its relationship with periodontal disease remains unclear.
This cross-sectional observational study will include 60 systemically healthy, non-smoking participants: 30 periodontally healthy individuals and 30 patients diagnosed with Stage III-IV periodontitis. Periodontal clinical parameters will be recorded for all participants.
Unstimulated saliva samples will be collected before periodontal surgical procedures. Gingival tissue samples will be obtained during clinically indicated periodontal surgical procedures, including crown-lengthening procedures in periodontally healthy participants and periodontal surgery in participants with periodontitis.
Boron levels will be determined in saliva and gingival tissue samples. Oxidative stress and antioxidant defense will be evaluated using selected biomarkers, including reactive oxygen species, total oxidant status, malondialdehyde, total antioxidant status, glutathione, superoxide dismutase, and catalase. Interleukin-1 beta will be evaluated as an inflammatory marker.
Boron levels and biochemical parameters will be compared between periodontally healthy individuals and participants with periodontitis, and their relationships with periodontal clinical parameters, oxidative stress, antioxidant defense, and inflammation will be investigated.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: LEYLA KURU
- Telefonnummer: +905363791443
- E-post: lkuru@marmara.edu.tr
Studieorter
-
-
Maltepe
-
Istanbul, Maltepe, Turkiet (Türkiye), 34854
- Rekrytering
- : Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul,
-
Kontakt:
- ECMEL BERİL ÖNER
- Telefonnummer: +905399734949
- E-post: beril_yusuf@hotmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Volunteering to participate in the study and signing the informed consent form
- Being between 18 and 65 years of age
- Being systemically healthy
- No antibiotic use within the last 3 months
- No periodontal treatment within the last 6 months
- Being a non-smoker or having quit smoking at least 5 years ago
- Not being pregnant or breastfeeding
- No current use of steroids, immunosuppressive drugs, or non-steroidal anti-inflammatory drugs
- No current use of medications associated with gingival enlargement, such as calcium channel blockers, phenytoin, or cyclosporine
- No regular use of boron-containing supplements or multivitamin complexes
- For the periodontally healthy group: no clinical attachment loss, bleeding on probing <10%, probing depth ≤3 mm, no radiographic bone loss, and an indication for crown-lengthening surgery
- For the periodontitis group: diagnosis of Stage III or IV periodontitis according to the 2017 World Workshop classification and an indication for periodontal flap surgery
Exclusion Criteria:
- Incomplete or unreliable clinical measurements
- Insufficient saliva or gingival tissue sample for biochemical analyses
- Regular use of boron-containing oral care products within the last 3 months
- Regular consumption of boron-rich supplements or mineral waters
- Failure to comply with the study protocol
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Periodontitis Group
Systemically healthy, non-smoking individuals diagnosed with Stage III-IV periodontitis who are scheduled for clinically indicated periodontal surgical treatment.
|
Unstimulated saliva and gingival tissue samples will be collected from participants.
Gingival tissue samples will be obtained during clinically indicated periodontal surgical procedures.
The samples will be biochemically analyzed to determine boron levels and markers of oxidative stress, antioxidant defense, and inflammation.
No experimental treatment or therapeutic intervention will be administered as part of the study.
|
|
Periodontally Healthy Group
Systemically healthy, non-smoking individuals with periodontal health who are scheduled for clinically indicated crown-lengthening surgery.
|
Unstimulated saliva and gingival tissue samples will be collected from participants.
Gingival tissue samples will be obtained during clinically indicated periodontal surgical procedures.
The samples will be biochemically analyzed to determine boron levels and markers of oxidative stress, antioxidant defense, and inflammation.
No experimental treatment or therapeutic intervention will be administered as part of the study.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Boron Levels in Saliva and Gingival Tissue
Tidsram: At the time of the clinically indicated periodontal surgical procedure
|
Boron levels will be measured in unstimulated saliva and gingival tissue samples obtained from participants in the periodontitis and periodontally healthy groups.
Salivary boron levels will be expressed as µg/mL and gingival tissue boron levels as µg/g.
|
At the time of the clinically indicated periodontal surgical procedure
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Oxidative Stress Markers
Tidsram: At the time of the clinically indicated periodontal surgical procedure
|
Oxidative stress will be assessed by measuring reactive oxygen species (ROS), total oxidant status (TOS), and malondialdehyde (MDA) levels in samples obtained from the periodontitis and periodontally healthy groups.
|
At the time of the clinically indicated periodontal surgical procedure
|
|
Antioxidant Defense Markers
Tidsram: At the time of the clinically indicated periodontal surgical procedure
|
Antioxidant defense will be assessed by measuring total antioxidant status (TAS), glutathione (GSH), superoxide dismutase (SOD), and catalase (CAT) levels in samples obtained from the periodontitis and periodontally healthy groups.
|
At the time of the clinically indicated periodontal surgical procedure
|
|
Inflammatory Marker
Tidsram: At the time of the clinically indicated periodontal surgical procedure
|
Inflammation will be assessed by measuring interleukin-1 beta (IL-1β) levels in samples obtained from the periodontitis and periodontally healthy groups.
|
At the time of the clinically indicated periodontal surgical procedure
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026-9
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .