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

NCT07683741 | Completed DMC

• 1 other identifier: RTEU Collagen Preparate
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontitis (Stage 3)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• assessment of interleukin-1 beta levels

  baseline, 1st month and 3th month

• assessment of matrix metalloproteinase-8 (MMP-8) levels

  baseline, 1st month and 3 th month

Study Arms (2)

Patients using collagen peptides

ACTIVE COMPARATOR

Dietary Supplement: Collagen hydrolyzed peptides

placebo group

PLACEBO COMPARATOR

Other: Placebo + cognitive behavioral therapy

Interventions

Collagen hydrolyzed peptides DIETARY_SUPPLEMENT

Collagen supplements will not be given in the placebo group.

Patients using collagen peptides

Placebo + cognitive behavioral therapy OTHER

placebo will be given.

placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age
• stage 3-4 periodontitis

You may not qualify if:

• 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

Sponsors & Collaborators

• Hatice Yemenoglu: lead

Study Sites (1)

Recep Tayyip Erdogan University

Rize, Rize Province, 53000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 6, 2026
• Study Start: February 10, 2025
• Primary Completion: May 30, 2026
• Study Completion: May 30, 2026
• Last Updated: July 6, 2026

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)