Hydrolyzed Collagen As A Host Modulation Agent in Non-Surgical Periodontal Treatment
Investigation of the Host Modulator Efficacy of Food Supplement Containing Hydrolyzed Collagen in Non-Surgical Periodontal Treatment of Patients With Periodontitis
This study was planned on the basis of the hypothesis that 'food supplements containing collagen will support the clinical effectiveness of non-surgical periodontal therapy'. In this context, the aim of the study is to investigate the therapeutic efficacy of collagen-containing food supplement as a host modulation agent in the non-surgical periodontal treatment of individuals with stage 3-4 periodontitis in a clinical and biochemical manner in a comprehensive manner.
Initial day: Anamnesis, diagnosis and index measurements 2 days later, collection of serum samples from the patient, oral hygiene training and straightening of the whole mouth root surface and cleaning of the whole mouth tooth surface The next day, full mouth scalling and root planing are closed with the second session and tablets are started.
End of 2nd month:
Periodontal index measurement and oral hygiene training Collecting serum and tissue samples 2 days later
End of 6th month Periodontal index measurement and oral hygiene training Collecting serum and tissue samples 2 days later
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Rize Province
-
Rize, Rize Province, Turkiet (Türkiye), 53000
- Recep Tayyip Erdogan University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- 18 - 60 age
- stage 3-4 periodontitis
Exclusion Criteria:
- Patients who smoke more than 10 cigarettes a day
- Patients using immunosuppressive, oral contraceptive, bisphosphonate drugs
- Patients who are during pregnancy or lactation
- Having undergone periodontal treatment in the last 6 months, having used antibiotic anti-inflammatory medication in the last 4 weeks
- The presence of any autoimmune disease, osteoporotic disease or cancer disease
- Patients with renal and hepatic insufficiency
- Patients with thyroid dysfunction
- The presence of active infectious diseases(acute hepatitis, tuberculosis, AIDS)
- Chronic drug use affecting periodontal tissues(cyclosporine A, Phenytoin)
- Intake of antioxidant supplements
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: placebogruppen
|
placebo will be given.
|
|
Aktiv komparator: Patients using collagen peptides
|
Collagen supplements will not be given in the placebo group.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
probing pocket depth
Tidsram: baseline, 1st month and 3rd month
|
The distance between the gingival margin and the pocket base was measured in millimeters.
|
baseline, 1st month and 3rd month
|
|
clinical attachment loss
Tidsram: baseline, 1st month and 3th month
|
The distance from the enamel-cementum junction to the pocket base was measured in millimeters.
|
baseline, 1st month and 3th month
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
assessment of interleukin-1 beta levels
Tidsram: baseline, 1st month and 3th month
|
Serum interleukin-1 beta levels were measured biochemically.
|
baseline, 1st month and 3th month
|
|
assessment of matrix metalloproteinase-8 (MMP-8) levels
Tidsram: baseline, 1st month and 3 th month
|
Matrix metalloproteinase-8 (MMP-8) levels in gingival crevicular fluid were measured biochemically.
|
baseline, 1st month and 3 th month
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
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
- RTEU Collagen Preparate
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
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