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Completed

NCT Number: NCT07683741

Hydrolyzed Collagen As A Host Modulation Agent in Non-Surgical Periodontal Treatment

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

Completed

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Key information

Conditions

Periodontitis (Stage 3) Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Recep Tayyip Erdogan University

Rize, Rize Province, 53000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collagen hydrolyzed peptides

Dietary Supplement

Collagen supplements will not be given in the placebo group.

Placebo + cognitive behavioral therapy

Other

placebo will be given.

Primary outcomes

  1. probing pocket depth

    Time frame: baseline, 1st month and 3rd month

    The distance between the gingival margin and the pocket base was measured in millimeters.

  2. clinical attachment loss

    Time frame: baseline, 1st month and 3th month

    The distance from the enamel-cementum junction to the pocket base was measured in millimeters.

Secondary outcomes

  1. assessment of interleukin-1 beta levels

    Time frame: baseline, 1st month and 3th month

    Serum interleukin-1 beta levels were measured biochemically.

  2. assessment of matrix metalloproteinase-8 (MMP-8) levels

    Time frame: baseline, 1st month and 3 th month

    Matrix metalloproteinase-8 (MMP-8) levels in gingival crevicular fluid were measured biochemically.

Sponsors and collaborators

Lead sponsor

Hatice Yemenoglu

Other

Registry information

Official study title

Investigation of the Host Modulator Efficacy of Food Supplement Containing Hydrolyzed Collagen in Non-Surgical Periodontal Treatment of Patients With Periodontitis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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