PeriodontitisCHX-ZnNCT07517991
Chlorhexidine and Zinc in Non-Surgical Periodontal Therapy
A study testing Chlorhexidine and zinc application and Scaling and root planing with distilled water in people with Periodontitis and Periodontitis Stage I, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis, Periodontitis Stage I, Periodontitis Stage II
- What is being tested?
- Chlorhexidine and zinc application and Scaling and root planing with distilled water
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jun 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Faculty of Dentistry
Erzurum, Erzurum
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Periodontitis, Periodontitis Stage I, Periodontitis Stage II
- Being tested
- Chlorhexidine and zinc application, Scaling and root planing with distilled water
- Keywords
- Chlorhexidine, Zinc, Scaling and Root Planing, Non-Surgical Periodontal Therapy, Inflammatory Biomarkers, CRP, Oncostatin M, Randomized Controlled Trial
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine and zinc applicationProcedure or surgery
Scaling and root planing is performed using an ultrasonic device with a solution containing chlorhexidine and zinc.
Scaling and root planing with distilled waterProcedure or surgery
Scaling and root planing is performed using an ultrasonic device with distilled water.
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine-Zinc Adjunctive SRP | Experimental | Participants receive scaling and root planing with adjunctive chlorhexidine and zinc. Receives: 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. Receives: Procedure: Scaling and root planing with distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Pocket Depth (PPD)
Measurement of periodontal pocket depth in millimeters to evaluate clinical periodontal improvement.
Measured: Baseline, 1 month, and 3 months
Clinical Attachment Level (CAL)
Assessment of clinical attachment level in millimeters as an indicator of periodontal tissue healing.
Measured: Baseline, 1 month, and 3 months
Secondary outcomes (6)
Plaque Index (PI)
Measurement of dental plaque accumulation.
Measured: Baseline, 1 month, and 3 months
Bleeding on Probing (BOP)
Assessment of gingival bleeding following periodontal probing.
Measured: Baseline, 1 month, and 3 months
C-Reactive Protein (CRP)
Measurement of systemic inflammatory response using serum CRP levels.
Measured: Baseline, 1 month, and 3 months
High-Sensitivity C-Reactive Protein (hs-CRP)
Measurement of low-grade systemic inflammation using high-sensitivity CRP levels.
Measured: Baseline, 1 month, and 3 months
Oncostatin M (OSM)
Evaluation of inflammatory cytokine levels associated with periodontal disease.
Measured: Baseline, 1 month, and 3 months
Antistreptolysin O (ASO)
Measurement of systemic immune response related to streptococcal exposure.
Measured: Baseline, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start16 Jun 2025
- Primary completion26 Mar 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alparslan Dilsiz, Ataturk University
- Investigators
- Alparslan Dilsiz, Professor, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517991
- Sponsor's protocol ID
- ATAUNI-CHX-ZINC-2025
- Acronym
- CHX-Zn
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations. The study involves a limited number of participants from a single center, and no formal data-sharing plan has been established.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chlorhexidine and Zinc as Adjuncts to Non-Surgical Periodontal Therapy in Stage I and II Periodontitis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07517991
- Acronym / sponsor ID
- CHX-Zn / ATAUNI-CHX-ZINC-2025
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 26 Mar 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine-Zinc Adjunctive SRP | Experimental | Procedure: Chlorhexidine and zinc applicationParticipants receive scaling and root planing with adjunctive chlorhexidine and zinc. |
| SRP with Distilled Water | Active comparator | Procedure: Scaling and root planing with distilled waterParticipants receive scaling and root planing (SRP) using an ultrasonic device with distilled water. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine and zinc applicationScaling and root planing is performed using an ultrasonic device with a solution containing chlorhexidine and zinc. | Procedure or surgery | Chlorhexidine-Zinc Adjunctive SRP |
| Scaling and root planing with distilled waterScaling and root planing is performed using an ultrasonic device with distilled water. | Procedure or surgery | SRP with Distilled Water |
Primary outcome
Probing Pocket Depth (PPD)
Time frame: Baseline, 1 month, and 3 months
Measurement of periodontal pocket depth in millimeters to evaluate clinical periodontal improvement.
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.
6 secondary outcomes
Plaque Index (PI)
Time frame: Baseline, 1 month, and 3 months
Bleeding on Probing (BOP)
Time frame: Baseline, 1 month, and 3 months
C-Reactive Protein (CRP)
Time frame: Baseline, 1 month, and 3 months
High-Sensitivity C-Reactive Protein (hs-CRP)
Time frame: Baseline, 1 month, and 3 months
Oncostatin M (OSM)
Time frame: Baseline, 1 month, and 3 months
Antistreptolysin O (ASO)
Time frame: Baseline, 1 month, and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Provides the current classification system for periodontitis (2017), which forms the basis for patient selection in this study.Link provided by the sponsor.
- Demonstrates the clinical and microbiological benefits of adjunctive subgingival irrigation in combination with scaling and root planing in patients with chronic periodontitis.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations. The study involves a limited number of participants from a single center, and no formal data-sharing plan has been established.
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alparslan Dilsiz, Professor principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine and zinc application and Scaling and root planing with distilled water in people with Periodontitis and Periodontitis Stage I, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Pocket Depth (PPD) (time frame: Baseline, 1 month, and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.