Chlorhexidine and Zinc in Non-Surgical Periodontal Therapy

NCT07517991 | Completed

• 1 other identifier: ATAUNI-CHX-ZINC-2025
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontitis is a chronic inflammatory disease affecting the supporting structures of the teeth and is associated with both local tissue destruction and systemic inflammatory responses. Non-surgical periodontal therapy, particularly scaling and root planing (SRP), is the primary treatment approach; however, it may not completely eliminate pathogenic microorganisms in all cases. Adjunctive antimicrobial agents may improve treatment outcomes by enhancing bacterial reduction and modulating inflammation. Chlorhexidine (CHX) is widely used for its antimicrobial properties, while zinc has anti-inflammatory and immunomodulatory effects. The combined use of CHX and zinc may provide synergistic benefits in periodontal therapy. The aim of this randomized controlled clinical trial is to evaluate the clinical and biochemical effects of CHX and zinc as adjuncts to SRP in individuals with stage I and II periodontitis. A total of 44 systemically healthy participants will be randomly assigned to two groups. The test group will receive SRP with CHX and zinc, while the control group will receive SRP with distilled water. Clinical periodontal parameters (Plaque Index, Bleeding on Probing, Probing Pocket Depth, and Clinical Attachment Level) and biochemical markers (C-reactive protein, high-sensitivity CRP, Oncostatin M, and Antistreptolysin O) will be evaluated at baseline, 1 month, and 3 months. The results of this study are expected to provide evidence regarding the potential benefits of CHX and zinc in improving periodontal treatment outcomes and reducing systemic inflammation.

Conditions

Periodontitis; Periodontitis Stage I; Periodontitis Stage II

Keywords

Chlorhexidine; Zinc; Scaling and Root Planing; Non-Surgical Periodontal Therapy; Inflammatory Biomarkers; CRP; Oncostatin M; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Probing Pocket Depth (PPD)

  Measurement of periodontal pocket depth in millimeters to evaluate clinical periodontal improvement.

  Baseline, 1 month, and 3 months

• Clinical Attachment Level (CAL)

  Assessment of clinical attachment level in millimeters as an indicator of periodontal tissue healing.

  Baseline, 1 month, and 3 months

Secondary Outcomes (6)

• Plaque Index (PI)

  Baseline, 1 month, and 3 months

• Bleeding on Probing (BOP)

  Baseline, 1 month, and 3 months

• C-Reactive Protein (CRP)

  Baseline, 1 month, and 3 months

• High-Sensitivity C-Reactive Protein (hs-CRP)

  Baseline, 1 month, and 3 months

• Oncostatin M (OSM)

  Baseline, 1 month, and 3 months

Study Arms (2)

Chlorhexidine-Zinc Adjunctive SRP

EXPERIMENTAL

Participants receive scaling and root planing with adjunctive chlorhexidine and zinc.

Procedure: Chlorhexidine and zinc application

SRP with Distilled Water

ACTIVE COMPARATOR

Participants receive scaling and root planing (SRP) using an ultrasonic device with distilled water.

Procedure: Scaling and root planing with distilled water

Interventions

Chlorhexidine and zinc application PROCEDURE

Scaling and root planing is performed using an ultrasonic device with a solution containing chlorhexidine and zinc.

Chlorhexidine-Zinc Adjunctive SRP

Scaling and root planing with distilled water PROCEDURE

Scaling and root planing is performed using an ultrasonic device with distilled water.

SRP with Distilled Water

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged between 18 and 65 years
• Systemically healthy individuals
• Diagnosed with Stage I or Stage II periodontitis according to the 2017 classification
• Having probing pocket depth ≤5 mm and clinical attachment loss ≤4 mm
• Having a sufficient number of teeth for periodontal evaluation
• Willing to participate and able to provide informed consent

You may not qualify if:

• Presence of systemic diseases affecting periodontal health
• Pregnancy or breastfeeding
• Smoking
• Use of antibiotics or anti-inflammatory drugs within the last 6 months
• History of periodontal treatment within the last 6 months
• Fewer than 15 teeth present
• History of radiotherapy or chemotherapy

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Faculty of Dentistry

Erzurum, Erzurum, Turkey (Türkiye)

Location

Related Links

• Provides the current classification system for periodontitis (2017), which forms the basis for patient selection in this study.
• Demonstrates the clinical and microbiological benefits of adjunctive subgingival irrigation in combination with scaling and root planing in patients with chronic periodontitis.

MeSH Terms

Conditions

Periodontitis

Interventions

Chlorhexidine; Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Alparslan Dilsiz, Professor

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical outcome assessor is blinded to group allocation. The operator performing the treatment is aware of the intervention, while participants are not explicitly informed about group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are randomly assigned to two parallel groups: a test group receiving scaling and root planing with chlorhexidine and zinc, and a control group receiving scaling and root planing with distilled water.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 8, 2026
• Study Start: June 16, 2025
• Primary Completion: March 26, 2026
• Study Completion: April 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)