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

Sponsor

Istanbul Medeniyet University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04946617

Collaborator

(none)

120

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mouth and Tooth Diseases Periodontal Diseases Gingivitis	Drug: undefined

Detailed Description

Periodontal health continues with a balanced interaction of the oral microflora with the host defense line.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 20, 2021

Anticipated Primary Completion Date :

Dec 20, 2021

Anticipated Study Completion Date :

Dec 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
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 Rinsing with mouthwashes Other Names: Mouthwash Product
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 Rinsing with mouthwashes Other Names: Mouthwash Product
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 Rinsing with mouthwashes Other Names: Mouthwash Product

Arm

Intervention/Treatment

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

Rinsing with mouthwashes

Other Names:

Mouthwash Product

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

Rinsing with mouthwashes

Other Names:

Mouthwash Product

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

Rinsing with mouthwashes

Other Names:

Mouthwash Product

Outcome Measures

Primary Outcome Measures

Rate of periodontal parametres changes [6 Months]
Incidence of Gingivitis
Rate of periodontal parametres changes [6 Months]
Incidence of Periodontitis

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 40 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Istanbul Medeniyet University

Investigators

Principal Investigator: Mustafa C Yavuz, PhD, Istanbul Medeniyet University

Study Documents (Full-Text)

None provided.

More Information

Publications

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. Review.

Responsible Party:

Mustafa Cihan Yavuz, Assistant Professor, Istanbul Medeniyet University

ClinicalTrials.gov Identifier:

NCT04946617

Other Study ID Numbers:

9.2.2017-30

First Posted:

Jul 1, 2021

Last Update Posted:

Jul 1, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mustafa Cihan Yavuz, Assistant Professor, Istanbul Medeniyet University

Periodontitis

Gingivitis

Mouthwashes

Additional relevant MeSH terms:

Gingivitis

Periodontal Diseases

Tooth Diseases

Stomatognathic Diseases

Study Results

No Results Posted as of Jul 1, 2021