Efficacy of Zinc L-Carnosine Mouth Rinse

NCT04430998 | Unknown Phase 3

• 1 other identifier: COCMFFP-M-01-2020
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical trial to assess the effect of a Zinc-L-Carnosine-based mouth rinse on periodontal tissues and pain after scaling and root planing

Conditions

Periodontal Index; Pain

Keywords

Periodontal index; Pain

Outcome Measures

Primary Outcomes (2)

• Change in Healing Index (H.I.)

  The Laundry-Turnbull and Howley index will be used to evaluate healing, considering the changes made by Pippi et al. In 2015. In particular, seven parameters will be assessed, to each of which a value of 1 or 0 will be assigned. The sum of the values will indicate the degree of healing to be compared between the different groups. These seven parameters are: redness of mucosa, granulation tissue, suppuration, swelling, re-epithelialization, bleeding, pain on palpation. Higher score means worse outcome.

  0, 7, 21 days

• Change in the Visual Analogue Scale (VAS) of pain

  Participants will be asked to mark the perceived degree of pain on a scale of 100 dashes, with the lowest score being "no pain" and the highest "the worst pain". Higher score means worse outcome.

  0, 7, 21 days

Secondary Outcomes (4)

• Change in Modified Sulcus Bleeding index (Mombelli) (mSBI)

  0, 7, 21 days

• Change in Full Mouth Plaque Score (O'Leary) (FMPS)

  0, 7, 21 days

• Change in Calculus index (Volpe-Manhold index) (VMI)

  0, 7, 21 days

• Change in Stain index (Macpherson stain index) (S.I.)

  0, 7, 21 days

Study Arms (3)

Zinc L-Carnosine mouth rinse

EXPERIMENTAL

Using undiluted 10 ml of Zinc L-Carnosine mouth rinse, retain for 60 seconds, 3 times daily

Drug: Zinc L-Carnosine

Chlorhexidine

ACTIVE COMPARATOR

Using undiluted 10 ml of Chlorhexidine mouth rinse, retain for 60 seconds, 3 times daily

Drug: Chlorhexidine

Water

PLACEBO COMPARATOR

Mouth rinsing with 10 ml of water, retain for 60 seconds, 3 times daily

Other: Water

Interventions

Zinc L-Carnosine DRUG

Undiluted 10 ml of Zinc L-Carnosine mouth rinse, retain for 3 minutes, 3 times daily

Also known as: Hepilor

Zinc L-Carnosine mouth rinse

Chlorhexidine DRUG

Undiluted 10 ml of Chlorhexidine mouth rinse, retain for 3 minutes, 3 times daily

Also known as: Curasept

Chlorhexidine

Water OTHER

Rinse mouth with 10 ml of water, retain for 3 minutes, 3 times daily

Water

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a PSR score greater than 2 that undergo a session of scaling and root planing

You may not qualify if:

• Use of mouth rinses or local or general medication in the preceding three weeks
• Any condition related with allergy or sensitivity with the mouth rinses ingredients
• Systemic and chronic diseases in progress

Sponsors & Collaborators

• University of Milan: lead
• Azienda Farmaceutica Italiana SRL: collaborator

Study Sites (1)

UOC Maxillofacial Surgery and Odontology, University of Milan

Milan, Lombardy, 20122, Italy

Location

Related Publications (5)

• Doi H, Fujiwara M, Suzuki H, Niwa Y, Nakayama M, Shikata T, Odawara S, Takada Y, Kimura T, Kamikonya N, Hirota S. Polaprezinc reduces the severity of radiation-induced mucositis in head and neck cancer patients. Mol Clin Oncol. 2015 Mar;3(2):381-386. doi: 10.3892/mco.2014.479. Epub 2014 Dec 19.

  PMID: 25798271 BACKGROUND

• Loe H. Oral hygiene in the prevention of caries and periodontal disease. Int Dent J. 2000 Jun;50(3):129-39. doi: 10.1111/j.1875-595x.2000.tb00553.x.

  PMID: 10967765 BACKGROUND

• Tartaglia GM, Kumar S, Fornari CD, Corti E, Connelly ST. Mouthwashes in the 21st century: a narrative review about active molecules and effectiveness on the periodontal outcomes. Expert Opin Drug Deliv. 2017 Aug;14(8):973-982. doi: 10.1080/17425247.2017.1260118. Epub 2016 Nov 20.

  PMID: 27835926 BACKGROUND

• Van der Weijden FA, Van der Sluijs E, Ciancio SG, Slot DE. Can Chemical Mouthwash Agents Achieve Plaque/Gingivitis Control? Dent Clin North Am. 2015 Oct;59(4):799-829. doi: 10.1016/j.cden.2015.06.002.

  PMID: 26427569 BACKGROUND

• Omatsu T, Naito Y, Handa O, Mizushima K, Hayashi N, Qin Y, Harusato A, Hirata I, Kishimoto E, Okada H, Uchiyama K, Ishikawa T, Takagi T, Yagi N, Kokura S, Ichikawa H, Yoshikawa T. Reactive oxygen species-quenching and anti-apoptotic effect of polaprezinc on indomethacin-induced small intestinal epithelial cell injury. J Gastroenterol. 2010 Jul;45(7):692-702. doi: 10.1007/s00535-010-0213-9. Epub 2010 Feb 20.

  PMID: 20174833 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

polaprezinc; Chlorhexidine; chlorhexidine gluconate; Water

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Chiara Occhipinti, Professor

  University of Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara Occhipinti, Professor

CONTACT

+393339155689; Chiara.Occhipinti@unimi.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2020
• First Posted: June 16, 2020
• Study Start: June 1, 2020
• Primary Completion: June 22, 2020
• Study Completion: June 30, 2020
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)