Effects of a Composition on the Oral Microbiome, pH, Nitrite/Nitrate Ratio, Elastases and Inflammation in Oral Dysbiosis

NCT05463484 | Completed Phase 2 DMC

• 1 other identifier: 02-2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Dysbiosis is a condition in which the normal function of an ecological net is altered. In dysbiosis a state of inflammation, a loss of hydration, a change in pH, a loss of the barrier function are all allies of key pathogens that initiate invasion and cytokine and pro-inflammatory mediators release that target other tissues and organs resulting in chronic inflammatory conditions. In health there is a cross-talk between the host and the microbiota in order to maintain and promote a state of eubiosis with a local and general health gain. Dysbiosis reversion has not been solved with the use of antibacterials, antiseptics nor antibiotics. Stop dysbiosis project is focussed on different aspects of human dysbiosis such as oral dysbiosis, skin dysbiosis, vaginal dysbiosis and cancer dysbiosis, between others including the current prospective interventional double-blind randomised clinical trial. One of the most common oral dysbiosis is periodontal and mucosa dysbiosis that courses with inflammation of the gingiva (gingivitis). This inflammation induces specific enzymes that in a later stage destroy connective tissue. The current clinical trial analyzes the effect of a composition (Saliactive ®) delivered to the oral cavity via a daily use toothpaste (YOTUEL® microbiome toothpaste) in a group of patients with oral dysbiosis.

Conditions

Oral Dysbiosis

Keywords

Gum inflammation; Periodontal Dysbiosis; Oral Dysbiosis

Outcome Measures

Primary Outcomes (6)

• Oral microbiota profile at baseline and after 4 months

  16s rDNA genetic sequencing

  4 months

• Oral pH at baseline and after 4 months

  pH meter

  4 months

• Nitrite/Nitrate ratio at baseline and after 4 months

  Ionic chromatography

  4 months

• Elastase at baseline at 2 months and at 4 months

  ELISA

  4 months

• Bleeding index at baseline, at 2 months and at 4 months

  Ainamo and Bay bleeding index indicating the percentage of bleeding from 0 (no bleeding) to 100 (maximum bleeding)

  4 months

• Plaque index at baseline, at 2 months and at 4 months

  Tonetti plaque index

  4 months

Secondary Outcomes (1)

• Salivary flow rate at baseline, 2 months and at 4 months

  4 months

Other Outcomes (1)

• Tooth colour at baseline and at 4 months

  4 months

Study Arms (3)

Test product

EXPERIMENTAL

Toothpaste including an olive product, betaine and xylitol (Saliactive®).

Drug: Test composition Saliactive® (olive product, betaine and xylitol)

Placebo product

PLACEBO COMPARATOR

Toothpaste with the same composition as the test product but without olive product, betaine and xylitol.

Drug: Placebo

Control product

ACTIVE COMPARATOR

Toothpaste marketed for gingivitis with zinc mineral with antimicrobial activity.

Drug: Control

Interventions

Test composition Saliactive® (olive product, betaine and xylitol) DRUG

Fluoridated toothpaste with Saliactive®.

Also known as: Saliactive®

Test product

Placebo DRUG

Fluoridated toothpaste without Saliactive®.

Also known as: Placebo fluoridated toothpaste without the test composition

Placebo product

Control DRUG

Commercial Fluoridated toothpaste for gingivitis with zinc citrate.

Also known as: Control commercial Fluoridated toothpaste for gingivitis with zinc citrate.

Control product

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnose of gingivitis.
• At least 20 teeth (3rd molars excluded).
• Must Accept informed consent.

You may not qualify if:

• Clinical diagnose of periodontitis.
• With orthodontics.
• With removable dentures.
• With upper incisors restorated.
• Tumours in soft or hard tissues of the mouth.
• More than 5 caries lesions with immediate restorative need
• Antibiotics intake less than one month ago.
• Pregnant women.
• Other clinic assay at the moment.
• Dental prophylaxis less than 2 weeks before starting the study.

Sponsors & Collaborators

• Mucosa Innovations, S.L.: lead
• Universidad de Granada: collaborator

Study Sites (1)

Departamento de Estomatología, Facultad de Odontología

Granada, 18071, Spain

Location

Related Publications (5)

• Tonetti MS. The future of periodontology: new treatments for a new era. J Int Acad Periodontol. 2002 Jul;4(3):110-4.

  PMID: 12670090 BACKGROUND

• Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.

  PMID: 1058834 BACKGROUND

• Navazesh M. Methods for collecting saliva. Ann N Y Acad Sci. 1993 Sep 20;694:72-7. doi: 10.1111/j.1749-6632.1993.tb18343.x. No abstract available.

  PMID: 8215087 BACKGROUND

• Barbadoro P, Ponzio E, Coccia E, Prospero E, Santarelli A, Rappelli GGL, D'Errico MM. Association between hypertension, oral microbiome and salivary nitric oxide: A case-control study. Nitric Oxide. 2021 Jan 1;106:66-71. doi: 10.1016/j.niox.2020.11.002. Epub 2020 Nov 10.

  PMID: 33186726 BACKGROUND

• Bescos R, Ashworth A, Clarke C, Brookes ZL, Belfield L, Rodiles A, Casas-Agustench P, Farnham G, Liddle L, Burleigh M, White D, Easton C, Hickson M. Effects of Chlorhexidine mouthwash on the oral microbiome. Sci Rep. 2020 Mar 24;10(1):5254. doi: 10.1038/s41598-020-61912-4.

  PMID: 32210245 BACKGROUND

MeSH Terms

Conditions

Gingivitis

Interventions

Betaine; Xylitol

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Sugar Alcohols; Alcohols; Carbohydrates

Study Officials

• Francisco Luis Mesa Aguado

  Departamento de Estomatología, Facultad de Odontología

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three toothpastes will be included in the study; one with the composition including an olive product, betaine and xylitol, one with the same composition but without the olive product, betaine and xylitol, and one of a product marketed for gingivitis with and antimicrobial ingredient. Subjects are randomnly assigned and products will have a white label so that nor subject nor researcher will know the composition to be tested.

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 19, 2022
• Study Start: July 13, 2021
• Primary Completion: February 28, 2023
• Study Completion: July 15, 2023
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)