NCT04295525

Brief Summary

The aim of this study is to elucidate the mutual relationship between salivae characteristics and oral microbiome and to compare them with common oral disease; furthermore, by using specific bioinformatic tools to analyse the data, the potentials of Carnosine in preventing/treating oral diseases and its mechanism of action will be addressed by using quantitative proteomics.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
2.5 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

February 26, 2020

Last Update Submit

May 17, 2022

Conditions

Oral Diseases

Keywords

dental erosionscariespériodontopathies

Outcome Measures

Primary Outcomes (3)

  • Effects on oral pH.

    Any change of oral pH from basal.

    7 days

  • Saliva Production unstimulated.

    Change of oral saliva production, unstimulated.

    7 days

  • Saliva Production stimulated.

    Change of oral saliva production, stimulated.

    7 days

Study Arms (4)

Controls subjects placebo

PLACEBO COMPARATOR

Placebo mucoadhesive oral tablet

Dietary Supplement: placebo mucoadhesive oral tablet

Controls subjects active Treatment

EXPERIMENTAL

AqualiefTM 400 mg mucoadhesive oral tablet

Dietary Supplement: 400 mg mucoadhesive oral tablet

Diseased subjects placebo

PLACEBO COMPARATOR

Placebo mucoadhesive oral tablet

Dietary Supplement: placebo mucoadhesive oral tablet

Diseased subjects active Treatment

EXPERIMENTAL

AqualiefTM 400 mg mucoadhesive oral tablet

Dietary Supplement: 400 mg mucoadhesive oral tablet

Interventions

400 mg mucoadhesive oral tabletDIETARY_SUPPLEMENT

AqualiefTM (Metis Healthcare s.r.l., Milano, Italy)

Controls subjects active TreatmentDiseased subjects active Treatment
placebo mucoadhesive oral tabletDIETARY_SUPPLEMENT

placebo

Controls subjects placeboDiseased subjects placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • dental erosions (De)
  • caries (Ca)
  • périodontopathies (Pe)

You may not qualify if:

  • allergies/intolerances to the consumption of Carnosine
  • taking other food supplements
  • any type of drug treatment (interview)
  • smoking
  • pregnancy/lactation
  • any systemic diseases such as cardiovascular and respiratory, diabetes mellitus, HIV infection, or inflammatory conditions causing non-plaque dependent OD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical, Surgical, and Dental Sciences, Istituto Stomatologico Italiano, Aesthetic Dentistry, School of Dentistry, University of Milan, Milan, Italy.

Milan, 20122, Italy

Location

Related Publications (10)

  • de Almeida Pdel V, Gregio AM, Machado MA, de Lima AA, Azevedo LR. Saliva composition and functions: a comprehensive review. J Contemp Dent Pract. 2008 Mar 1;9(3):72-80.

    PMID: 18335122RESULT

  • Marsh PD, Do T, Beighton D, Devine DA. Influence of saliva on the oral microbiota. Periodontol 2000. 2016 Feb;70(1):80-92. doi: 10.1111/prd.12098.

    PMID: 26662484RESULT

  • Grassl N, Kulak NA, Pichler G, Geyer PE, Jung J, Schubert S, Sinitcyn P, Cox J, Mann M. Ultra-deep and quantitative saliva proteome reveals dynamics of the oral microbiome. Genome Med. 2016 Apr 21;8(1):44. doi: 10.1186/s13073-016-0293-0.

    PMID: 27102203RESULT

  • Abranches J, Zeng L, Kajfasz JK, Palmer SR, Chakraborty B, Wen ZT, Richards VP, Brady LJ, Lemos JA. Biology of Oral Streptococci. Microbiol Spectr. 2018 Oct;6(5):10.1128/microbiolspec.gpp3-0042-2018. doi: 10.1128/microbiolspec.GPP3-0042-2018.

    PMID: 30338752RESULT

  • Dolan E, Saunders B, Harris RC, Bicudo JEPW, Bishop DJ, Sale C, Gualano B. Comparative physiology investigations support a role for histidine-containing dipeptides in intracellular acid-base regulation of skeletal muscle. Comp Biochem Physiol A Mol Integr Physiol. 2019 Aug;234:77-86. doi: 10.1016/j.cbpa.2019.04.017. Epub 2019 Apr 25.

    PMID: 31029715RESULT

  • Boldyrev AA, Aldini G, Derave W. Physiology and pathophysiology of carnosine. Physiol Rev. 2013 Oct;93(4):1803-45. doi: 10.1152/physrev.00039.2012.

    PMID: 24137022RESULT

  • Ciulla MM, Paliotti R, Carini M, Magrini F, Aldini G. Fibrosis, Enzymatic and Non-Enzymatic Cross-Links in Hypertensive Heart Disease. Cardiovasc Hematol Disord Drug Targets. 2011;11(2):61-73. doi: 10.2174/187152911798347025.

    PMID: 22044034RESULT

  • Menon K, Mousa A, de Courten B. Effects of supplementation with carnosine and other histidine-containing dipeptides on chronic disease risk factors and outcomes: protocol for a systematic review of randomised controlled trials. BMJ Open. 2018 Mar 22;8(3):e020623. doi: 10.1136/bmjopen-2017-020623.

    PMID: 29567852RESULT

  • Zhang Y, Wang X, Li H, Ni C, Du Z, Yan F. Human oral microbiota and its modulation for oral health. Biomed Pharmacother. 2018 Mar;99:883-893. doi: 10.1016/j.biopha.2018.01.146. Epub 2018 Feb 20.

    PMID: 29710488RESULT

  • Holtfreter B, Albandar JM, Dietrich T, Dye BA, Eaton KA, Eke PI, Papapanou PN, Kocher T; Joint EU/USA Periodontal Epidemiology Working Group. Standards for reporting chronic periodontitis prevalence and severity in epidemiologic studies: Proposed standards from the Joint EU/USA Periodontal Epidemiology Working Group. J Clin Periodontol. 2015 May;42(5):407-12. doi: 10.1111/jcpe.12392. Epub 2015 May 7.

    PMID: 25808877RESULT

MeSH Terms

Conditions

Tooth Erosion

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesTooth Wear

Study Officials

  • Michele Ciulla, MD

    Lab. Clin. Informatics & Cardiovascular Imaging, University of Milan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dino Re, MD

CONTACT

+39-0254176231dino.re@unimi.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Principal Investigator

Study Record Dates

First Submitted

February 26, 2020

First Posted

March 4, 2020

Study Start

September 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)