Chlorhexidine and Essential Oil Mouthwashes on Human Beta-Defensin 2 (hbD2) and Kathelicidin (LL-37) Saliva Levels

NCT04946617 | Unknown

• 1 other identifier: 9.2.2017-30
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Recent studies have shown that while mouthwashes exhibit antimicrobial properties against bacteria and their products, at the same time showing the cytotoxic effect on living cells in the mouth.29 To the best of our knowledge, there is no information about the toxicity effect of these two mouthwashes, which are highly preferred, on antimicrobial peptides secreted from the oral epithelium. Therefore, our aim in this study is to evaluate the effect of chlorhexidine and essential oil mouthwash on hBD2 and LL-37 in saliva.

Conditions

Mouth and Tooth Diseases; Periodontal Diseases; Gingivitis

Keywords

Periodontitis; Gingivitis; Mouthwashes

Outcome Measures

Primary Outcomes (2)

• Rate of periodontal parametres changes

  Incidence of Gingivitis

  6 Months

• Rate of periodontal parametres changes

  Incidence of Periodontitis

  6 Months

Study Arms (3)

H group

healthy periodontium, BOP at \\20 % of the sites and no sites with probing depth (PD) \[3 mm and clinical attachment level (CAL) \[2 mm or alveolar bone loss (N = 20, 12 males, 8 females, mean age: 33.38

Drug: undefined

G group

gingivitis, BOP at ≥20 % of the sites and no sites with PD and CAL \[3 mm or bone loss (N = 20, 6 males, 14 females, mean age: 32.35);

Drug: undefined

CP group

chronic periodontitis, ≥4 teeth in each jaw with PD of ≥5 mm, CAL of C4 mm, BOP at \[≥80 % of the proximal sites and radiographic evidence of interproximal bone loss

Drug: undefined

Interventions

undefined DRUG

Rinsing with mouthwashes

Also known as: Mouthwash Product

CP group; G group; H group

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The sample size was calculated using (power of 80%). The present study included 40 patients per group (total of 120) to have a power \>80%.

You may qualify if:

• systemically healthy,
• presence of ≥20 natural teeth,
• agreement to participate in the study .

You may not qualify if:

• known systemic illness,
• smoking habit,
• pregnancy/ lactation,
• long-term use of anti-inflammatory drugs.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Related Publications (1)

• Van Dyke TE. Pro-resolving mediators in the regulation of periodontal disease. Mol Aspects Med. 2017 Dec;58:21-36. doi: 10.1016/j.mam.2017.04.006. Epub 2017 May 18.

  PMID: 28483532 BACKGROUND

MeSH Terms

Conditions

Stomatognathic Diseases; Periodontal Diseases; Gingivitis; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Infections; Gingival Diseases

Study Officials

• Mustafa C Yavuz, PhD

  Istanbul Medeniyet University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa C Yavuz, PhD

CONTACT

+905056429856; muscyz111@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 1, 2021
• Study Start: July 20, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: July 1, 2021

Record last verified: 2021-06