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
Brief Summary

Periodontitis is a chronic inflammatory disease affecting the supporting structures ofthe teeth and is associated with both local tissue destruction and systemic inflammatoryresponses. Non-surgical periodontal therapy, particularly scaling and root planing (SRP),is the primary treatment approach; however, it may not completely eliminate pathogenicmicroorganisms in all cases.Adjunctive antimicrobial agents may improve treatment outcomes by enhancing bacterialreduction and modulating inflammation. Chlorhexidine (CHX) is widely used for itsantimicrobial 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 andbiochemical effects of CHX and zinc as adjuncts to SRP in individuals with stage I and IIperiodontitis.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 receiveSRP with distilled water. Clinical periodontal parameters (Plaque Index, Bleeding onProbing, Probing Pocket Depth, and Clinical Attachment Level) and biochemical markers(C-reactive protein, high-sensitivity CRP, Oncostatin M, and Antistreptolysin O) will beevaluated at baseline, 1 month, and 3 months.The results of this study are expected to provide evidence regarding the potentialbenefits of CHX and zinc in improving periodontal treatment outcomes and reducingsystemic 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.

Completed
Periodontitis
Periodontitis Stage I
Periodontitis Stage II

Procedure: Chlorhexidine and zinc application

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

Procedure: Scaling and root planing with distilled water

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

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
Turkey (Türkiye)
Locations

Ataturk University Faculty of Dentistry
Erzurum, Erzurum, Turkey (Türkiye)

Alparslan Dilsiz, Professor, Principal Investigator
Ataturk University

Ataturk University
NCT Number
Keywords
Chlorhexidine
Zinc
Scaling and Root Planing
Non-surgical periodontal therapy
Inflammatory Biomarkers
CRP
Oncostatin M
randomized controlled trial
MeSH Terms
Periodontitis
Chlorhexidine
Tooth Exfoliation
Root Planing