- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07517991
Chlorhexidine and Zinc in Non-Surgical Periodontal Therapy (CHX-Zn)
The Effect of Chlorhexidine and Zinc as Adjuncts to Non-Surgical Periodontal Therapy in Stage I and II Periodontitis: A Randomized Controlled Clinical Trial
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Periodontitis is a multifactorial chronic inflammatory disease characterized by the destruction of tooth-supporting tissues, including gingiva, periodontal ligament, and alveolar bone. It is initiated by microbial dental plaque and modulated by the host immune response, leading to both local tissue damage and systemic inflammatory effects.
Scaling and root planing (SRP) is the gold standard for non-surgical periodontal therapy and aims to mechanically remove plaque and calculus from root surfaces. However, due to anatomical limitations and microbial persistence in periodontal pockets, SRP alone may not always achieve optimal clinical outcomes. Therefore, adjunctive antimicrobial and anti-inflammatory agents have been proposed to enhance treatment efficacy.
Chlorhexidine (CHX) is considered the gold standard antiseptic in dentistry due to its broad-spectrum antimicrobial activity and substantivity. Zinc, on the other hand, has been shown to possess anti-inflammatory, antioxidant, and immunomodulatory properties. The combination of CHX and zinc may provide a synergistic effect by reducing microbial load while simultaneously modulating the host inflammatory response.
This study is designed as a single-center, randomized, controlled, prospective clinical trial conducted at the Department of Periodontology, Faculty of Dentistry, Ataturk University. A total of 44 systemically healthy individuals aged between 18 and 65 years with stage I and II periodontitis will be included.
Participants will be randomly allocated into two groups using a coin-toss method:
- Test group: SRP with chlorhexidine and zinc
- Control group: SRP with distilled water
All participants will receive standardized oral hygiene instructions prior to treatment. SRP procedures will be performed using ultrasonic instruments. In the test group, chlorhexidine and zinc solution will be used during the procedure, whereas distilled water will be used in the control group.
Clinical periodontal parameters including Plaque Index (PI), Bleeding on Probing (BOP), Probing Pocket Depth (PPD), and Clinical Attachment Level (CAL) will be recorded at baseline, 1 month, and 3 months. In addition, blood and saliva samples will be collected at the same time points to analyze biochemical markers including C-reactive protein (CRP), high-sensitivity CRP (hs-CRP), Oncostatin M (OSM), and Antistreptolysin O (ASO) using ELISA methods.
The primary objective of this study is to evaluate the clinical effectiveness of CHX and zinc as adjuncts to SRP. The secondary objective is to assess their effects on systemic inflammatory biomarkers.
The findings of this study are expected to contribute to the understanding of adjunctive treatment strategies in periodontal therapy and may support the use of CHX and zinc combination as a practical and effective approach in clinical practice.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Erzurum
-
Erzurum, Erzurum, Turkey (Türkiye)
- Atatürk University Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chlorhexidine-Zinc Adjunctive SRP
Participants receive scaling and root planing with adjunctive chlorhexidine and zinc.
|
Scaling and root planing is performed using an ultrasonic device with a solution containing chlorhexidine and zinc.
|
|
Active Comparator: SRP with Distilled Water
Participants receive scaling and root planing (SRP) using an ultrasonic device with distilled water.
|
Scaling and root planing is performed using an ultrasonic device with distilled water.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Probing Pocket Depth (PPD)
Time Frame: Baseline, 1 month, and 3 months
|
Measurement of periodontal pocket depth in millimeters to evaluate clinical periodontal improvement.
|
Baseline, 1 month, and 3 months
|
|
Clinical Attachment Level (CAL)
Time Frame: Baseline, 1 month, and 3 months
|
Assessment of clinical attachment level in millimeters as an indicator of periodontal tissue healing.
|
Baseline, 1 month, and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plaque Index (PI)
Time Frame: Baseline, 1 month, and 3 months
|
Measurement of dental plaque accumulation.
|
Baseline, 1 month, and 3 months
|
|
Bleeding on Probing (BOP)
Time Frame: Baseline, 1 month, and 3 months
|
Assessment of gingival bleeding following periodontal probing.
|
Baseline, 1 month, and 3 months
|
|
C-Reactive Protein (CRP)
Time Frame: Baseline, 1 month, and 3 months
|
Measurement of systemic inflammatory response using serum CRP levels.
|
Baseline, 1 month, and 3 months
|
|
High-Sensitivity C-Reactive Protein (hs-CRP)
Time Frame: Baseline, 1 month, and 3 months
|
Measurement of low-grade systemic inflammation using high-sensitivity CRP levels.
|
Baseline, 1 month, and 3 months
|
|
Oncostatin M (OSM)
Time Frame: Baseline, 1 month, and 3 months
|
Evaluation of inflammatory cytokine levels associated with periodontal disease.
|
Baseline, 1 month, and 3 months
|
|
Antistreptolysin O (ASO)
Time Frame: Baseline, 1 month, and 3 months
|
Measurement of systemic immune response related to streptococcal exposure.
|
Baseline, 1 month, and 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alparslan Dilsiz, Professor, Ataturk University
Publications and helpful links
Helpful 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Periodontal Diseases
- Mouth Diseases
- Stomatognathic Diseases
- Periodontitis
- Organic Chemicals
- Biguanides
- Guanidines
- Amidines
- Digestive System and Oral Physiological Phenomena
- Dentistry
- Dental Physiological Phenomena
- Dental Scaling
- Dental Prophylaxis
- Periodontics
- Subgingival Curettage
- Preventive Dentistry
- Chlorhexidine
- Root Planing
- Tooth Exfoliation
Other Study ID Numbers
- ATAUNI-CHX-ZINC-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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