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

Study Overview

• Status: Completed
• Conditions: Periodontitis (Stage 3)
• Intervention / Treatment: Dietary supplement: Collagen hydrolyzed peptides; Other: Placebo + cognitive behavioral therapy

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Rize Province
    • Rize, Rize Province, Turkey (Türkiye), 53000
      • Recep Tayyip Erdogan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo group	Other: Placebo + cognitive behavioral therapy; placebo will be given.
Active Comparator: Patients using collagen peptides	Dietary supplement: Collagen hydrolyzed peptides; Collagen supplements will not be given in the placebo group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
probing pocket depth	The distance between the gingival margin and the pocket base was measured in millimeters.	baseline, 1st month and 3rd month
clinical attachment loss	The distance from the enamel-cementum junction to the pocket base was measured in millimeters.	baseline, 1st month and 3th month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of interleukin-1 beta levels	Serum interleukin-1 beta levels were measured biochemically.	baseline, 1st month and 3th month
assessment of matrix metalloproteinase-8 (MMP-8) levels	Matrix metalloproteinase-8 (MMP-8) levels in gingival crevicular fluid were measured biochemically.	baseline, 1st month and 3 th month

Collaborators and Investigators

• Sponsor: Hatice Yemenoglu

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Actual): May 30, 2026
• Study Completion (Actual): May 30, 2026

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: RTEU Collagen Preparate

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data can be shared for appropriate reasons if requested.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No