Efficacy of Different Chlorhexidine Concentrations

NCT02911766 | Unknown Phase 4

• 1 other identifier: 2015/608453
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Chlorhexidine is the gold standard of dental plaque prevention, but which concentration is the most effective is not known. The aim of the present study was to compare the plaque and gingivitis inhibiting effect of commercial products containing 0.2%, 0.12% and 0.06% chlorhexidine in a modified experimental gingivitis model. In three groups of healthy volunteers, experimental gingivitis was induced and monitored over 21days, simultaneously treated with the commercial solutions containing 0.2%, 0.12% and 0.06% chlorhexidine. The maxillary right quadrant of each individual received mouthwash only, whereas the maxillary left quadrant was subject to both rinsing and mechanical oral hygiene. Compliance and side effects were monitored at days 7, 14, and 21. Plaque and gingivitis scores were obtained at baseline and day 21. The commercial mouthwash containing 0.2% chlorhexidine resulted in statistically significantly lower plaque scores than the 0.12 and 0.06% mouthwashes after 21 days use, whereas no statistically significant difference was found between the effect of the two latter mouthrinses. A commercial available mouthwash containing 0.2% chlorhexidine proved statistically significant better effect in preventing dental plaque than 0.12% and 0.06% solutions.

Conditions

Dental Plaque; Gingivitis

Keywords

Periodontal Index

Outcome Measures

Primary Outcomes (1)

• Plaque index of Silness and Loe (PI) 1964

  0= No plaque 1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. 2. Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. 3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

  21 days

Secondary Outcomes (1)

• Gingival index of Løe (GI) and Silness 1963

  21 days

Other Outcomes (2)

• Side effects

  21 days

• subjective and objective discoloration of teeth

  21 days

Study Arms (3)

Corsodyl, 0.2% mouthrinse

ACTIVE COMPARATOR

The comparator solution was Corsodyl, 0.2% Chlorhexidine mouthrinse, Intervention Rinsing 60 sec with Comparator solution twice daily for 21 days

Drug: Chlorhexidine 0.2% Mouthrinse

FluxProKlorhexidine 0.12% mouthrinse

EXPERIMENTAL

The experimental solution was FluxProChlorhexidine 0.12% mouthrinse Intervention Rinsing 60 sec with test solution twice daily for 21 days

Drug: Chlorhexidine 0.12% mouthrinse

Corsodaily 0.06% mouthrinse

EXPERIMENTAL

The second experimental solution was Corsodaily, 0.06% chlorhexidine mouthrinse. Intervention Rinsing 60 sec with test solution twice daily for 21 days

Drug: Chlorhexidine 0.06% mouthrinse

Interventions

Chlorhexidine 0.2% Mouthrinse DRUG

Intervention; Rinsing 60 sec with Comparator solution twice daily for 21 days

Also known as: Corsodyl 0.2% Chlorhexidine mouthwash

Corsodyl, 0.2% mouthrinse

Chlorhexidine 0.12% mouthrinse DRUG

Intervention; Rinsing 60 sec with Comparator solution twice daily for 21 days

Also known as: FluxProChlorhexidine 0.12%

FluxProKlorhexidine 0.12% mouthrinse

Chlorhexidine 0.06% mouthrinse DRUG

Intervention; Rinsing 60 sec with Comparator solution twice daily for 21 days

Also known as: Corsodaily 0.06% chlorhexidine mouthwash

Corsodaily 0.06% mouthrinse

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• non-smoking subjects,
• healthy subjects
• having at least three of the following teeth in maxillary right and left quadrant: the canine, 1st bicuspid, 2nd bicuspid, 1st molar,
• healthy gingiva and periodontium

You may not qualify if:

• pregnancy
• lactation
• any chronic diseases
• clinical signs or symptoms of acute infection in the oral cavity
• any prescribed or non-prescription systemic or topical medication except oral contraceptives
• use of systemic antibiotics the last 3 months prior to the start of the study history of alcohol or drug abuse
• participation in other clinical studies in the last 4 weeks.

Sponsors & Collaborators

• University of Oslo: lead

Study Sites (1)

Department of Periodontology, Institute of Clinical Odontology, Dental Faculty, University of Oslo

Oslo, Oslo County, 0455, Norway

Location

Related Publications (27)

• Denton, G. W. Disinfection, Sterilization and Preservation, 4th ed, pp. 274-89.

  BACKGROUND

• Loe H, Schiott CR. The effect of mouthrinses and topical application of chlorhexidine on the development of dental plaque and gingivitis in man. J Periodontal Res. 1970;5(2):79-83. doi: 10.1111/j.1600-0765.1970.tb00696.x. No abstract available.

  PMID: 4254172 BACKGROUND

• Altman DG. Clinical trials. Practical statistics for medical research. London: Chapman & Hall/CRC; 1991. p 456.

  BACKGROUND

• Davies A. The mode of action of chlorhexidine. J Periodontal Res Suppl. 1973;12:68-75. doi: 10.1111/j.1600-0765.1973.tb02167.x. No abstract available.

  PMID: 4269603 RESULT

• Gjermo P. Hibitane in periodontal disease. J Clin Periodontol. 1977 Dec;4(5):94-101. doi: 10.1111/j.1600-051x.1977.tb00055.x. No abstract available.

  PMID: 275281 RESULT

• Hull PS. Chemical inhibition of plaque. J Clin Periodontol. 1980 Dec;7(6):431-42. doi: 10.1111/j.1600-051x.1980.tb02150.x.

  PMID: 7012186 RESULT

• Addy M. Chlorhexidine compared with other locally delivered antimicrobials. A short review. J Clin Periodontol. 1986 Nov;13(10):957-64. doi: 10.1111/j.1600-051x.1986.tb01434.x.

  PMID: 3540026 RESULT

• Owens J, Addy M, Faulkner J, Lockwood C, Adair R. A short-term clinical study design to investigate the chemical plaque inhibitory properties of mouthrinses when used as adjuncts to toothpastes: applied to chlorhexidine. J Clin Periodontol. 1997 Oct;24(10):732-7. doi: 10.1111/j.1600-051x.1997.tb00190.x.

  PMID: 9350557 RESULT

• Gjermo P, Rolla G, Arskaug L. Effect on dental plaque formation and some in vitro properties of 12 bis-biguanides. J Periodontal Res Suppl. 1973;12:81-92. doi: 10.1111/j.1600-0765.1973.tb02169.x. No abstract available.

  PMID: 4269606 RESULT

• Berchier CE, Slot DE, Van der Weijden GA. The efficacy of 0.12% chlorhexidine mouthrinse compared with 0.2% on plaque accumulation and periodontal parameters: a systematic review. J Clin Periodontol. 2010 Sep;37(9):829-39. doi: 10.1111/j.1600-051X.2010.01575.x. Epub 2010 Jul 7.

  PMID: 20618550 RESULT

• QUIGLEY GA, HEIN JW. Comparative cleansing efficiency of manual and power brushing. J Am Dent Assoc. 1962 Jul;65:26-9. doi: 10.14219/jada.archive.1962.0184. No abstract available.

  PMID: 14489483 RESULT

• Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.

  PMID: 5264376 RESULT

• Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.

  PMID: 5237684 RESULT

• LOE H, THEILADE E, JENSEN SB. EXPERIMENTAL GINGIVITIS IN MAN. J Periodontol (1930). 1965 May-Jun;36:177-87. doi: 10.1902/jop.1965.36.3.177. No abstract available.

  PMID: 14296927 RESULT

• Preus HR, Aass AM, Hansen BF, Moe B, Gjermo P. A randomized, single-blind, parallel-group clinical study to evaluate the effect of soluble beta-1,3/1,6-glucan on experimental gingivitis in man. J Clin Periodontol. 2008 Mar;35(3):236-41. doi: 10.1111/j.1600-051X.2007.01183.x.

  PMID: 18269662 RESULT

• Preus HR, Koldsland OC, Aass AM, Sandvik L, Hansen BF. The plaque- and gingivitis-inhibiting capacity of a commercially available essential oil product. A parallel, split-mouth, single blind, randomized, placebo-controlled clinical study. Acta Odontol Scand. 2013 Nov;71(6):1613-9. doi: 10.3109/00016357.2013.782506. Epub 2013 May 3.

  PMID: 23638764 RESULT

• Harper PR, Milsom S, Wade W, Addy M, Moran J, Newcombe RG. An approach to efficacy screening of mouthrinses: studies on a group of French products (II). Inhibition of salivary bacteria and plaque in vivo. J Clin Periodontol. 1995 Sep;22(9):723-7. doi: 10.1111/j.1600-051x.1995.tb00833.x.

  PMID: 7593704 RESULT

• Keijser JA, Verkade H, Timmerman MF, Van der Weijden FA. Comparison of 2 commercially available chlorhexidine mouthrinses. J Periodontol. 2003 Feb;74(2):214-8. doi: 10.1902/jop.2003.74.2.214.

  PMID: 12666710 RESULT

• Franco Neto CA, Parolo CC, Rosing CK, Maltz M. Comparative analysis of the effect of two chlorhexidine mouthrinses on plaque accumulation and gingival bleeding. Braz Oral Res. 2008 Apr-Jun;22(2):139-44. doi: 10.1590/s1806-83242008000200008.

  PMID: 18622483 RESULT

• Pizzo G, Guiglia R, Imburgia M, Pizzo I, D'Angelo M, Giuliana G. The effects of antimicrobial sprays and mouthrinses on supragingival plaque regrowth: a comparative study. J Periodontol. 2006 Feb;77(2):248-56. doi: 10.1902/jop.2006.050116.

  PMID: 16460251 RESULT

• Quirynen M, Avontroodt P, Peeters W, Pauwels M, Coucke W, van Steenberghe D. Effect of different chlorhexidine formulations in mouthrinses on de novo plaque formation. J Clin Periodontol. 2001 Dec;28(12):1127-36. doi: 10.1034/j.1600-051x.2001.281207.x.

  PMID: 11737510 RESULT

• Smith RG, Moran J, Addy M, Doherty F, Newcombe RG. Comparative staining in vitro and plaque inhibitory properties in vivo of 0.12% and 0.2% chlorhexidine mouthrinses. J Clin Periodontol. 1995 Aug;22(8):613-7. doi: 10.1111/j.1600-051x.1995.tb00814.x.

  PMID: 8583018 RESULT

• Van Strydonck DA, Timmerman MF, van der Velden U, van der Weijden GA. Plaque inhibition of two commercially available chlorhexidine mouthrinses. J Clin Periodontol. 2005 Mar;32(3):305-9. doi: 10.1111/j.1600-051X.2005.00681.x.

  PMID: 15766375 RESULT

• 26. Valør LO, Norton IKR, Koldsland OC, Aass AM, Sandvik L, Preus HR. The plaque- and gingivitis inhibiting capacity of a commercially available mouthwash containing essential oils and ethyl lauroyl arginate. A parallel, split-mouth, double blind, randomized, placebo-controlled clinical study. In press

  RESULT

• Preus HR, Dahlen G, Gjermo P, Baelum V. Microbiologic Observations After Four Treatment Strategies Among Patients With Periodontitis Maintaining a High Standard of Oral Hygiene: Secondary Analysis of a Randomized Controlled Clinical Trial. J Periodontol. 2015 Jul;86(7):856-65. doi: 10.1902/jop.2015.140620. Epub 2015 Mar 12.

  PMID: 25762359 RESULT

• Vatne JF, Gjermo P, Sandvik L, Preus HR. Patients' perception of own efforts versus clinically observed outcomes of non-surgical periodontal therapy in a Norwegian population: an observational study. BMC Oral Health. 2015 May 17;15:61. doi: 10.1186/s12903-015-0037-3.

  PMID: 25981528 RESULT

• Haydari M, Bardakci AG, Koldsland OC, Aass AM, Sandvik L, Preus HR. Comparing the effect of 0.06% -, 0.12% and 0.2% Chlorhexidine on plaque, bleeding and side effects in an experimental gingivitis model: a parallel group, double masked randomized clinical trial. BMC Oral Health. 2017 Aug 18;17(1):118. doi: 10.1186/s12903-017-0400-7.

  PMID: 28821290 DERIVED

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Hans R Preus, PhD

  Department of periodontics, Dental Faculty, UiO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hans R Preus, PhD

CONTACT

+47 22852163; hpreus@odont.uio.no

Jan E Ellingsen, PhD

CONTACT

+4722852141; j.e.e@odont.uio.no

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 22, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 5, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

NO (1)