Efficacy of Zinc L-Carnosine Mouth Rinse

Efficacy of a Zinc-L-Carnosine -Based Mouth Rinse on Periodontal Tissues and Pain After Scaling and Root Planing - a Randomized Clinical Trial; a Randomized Controlled Trial

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

Study Overview

• Status: Unknown
• Conditions: Pain; Periodontal Index
• Intervention / Treatment: Drug: Zinc L-Carnosine; Drug: Chlorhexidine; Other: Water

Detailed Description

A randomized, double blind, 3 group parallel study with random allocation of 75 patients to any of three groups; Zinc-L-Carnosine-based mouth rinse, Chlorhexidine mouth rinse and placebo (water) control. Three days after professional oral hygiene, which aimed at the normalization of the periodontal index, the primary (HI, VAS) and secondary (mSBI; FMPS; VMI; SI) outcomes of the study are measured to obtain baseline information, and then scaling and root planing are carried out.

The participants will be advised to follow their regular oral hygiene procedures (tooth brushing) in addition to the allocated mouth rinse. They will be examined again for primary and secondary outcomes at 7 and 21 days.

Clinical evaluation:

Clinical examination of each participant will be done by a single examiner using the previously described VAS scale and a UNC periodontal probe (No. 5 explorer Hu-Friedy, Chicago, Ill). In addition to these indices, each subject will be asked to report any adverse events they have encountered during the experiment.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • UOC Maxillofacial Surgery and Odontology, University of Milan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Zinc L-Carnosine mouth rinse; Using undiluted 10 ml of Zinc L-Carnosine mouth rinse, retain for 60 seconds, 3 times daily	Drug: Zinc L-Carnosine; Undiluted 10 ml of Zinc L-Carnosine mouth rinse, retain for 3 minutes, 3 times daily; Other Names: Hepilor
ACTIVE_COMPARATOR: Chlorhexidine; Using undiluted 10 ml of Chlorhexidine mouth rinse, retain for 60 seconds, 3 times daily	Drug: Chlorhexidine; Undiluted 10 ml of Chlorhexidine mouth rinse, retain for 3 minutes, 3 times daily; Other Names: Curasept
PLACEBO_COMPARATOR: Water; Mouth rinsing with 10 ml of water, retain for 60 seconds, 3 times daily	Other: Water; Rinse mouth with 10 ml of water, retain for 3 minutes, 3 times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Modified Sulcus Bleeding index (Mombelli) (mSBI)	The clinical examination of each participant will be carried out by a single examiner using the UNC periodontal probe and the explorer n. 5 (Hu-Friedy, Chicago, III) to assess sulcus bleeding and assign a score: 0 absence of bleeding; presence of bleeding on probing without redness and edema;; presence of bleeding on probing with redness and edema;; spontaneous bleeding. 6 sites (3 buccal + 3 lingual / palatal) are considered for each tooth. Higher score means worse outcome.	0, 7, 21 days
Change in Full Mouth Plaque Score (O'Leary) (FMPS)	Quantitative plaque index, indicates presence of plaque on teeth. Six sites (3 buccal + 3 lingual / palatal) are considered for each tooth, to which a score is given: 0: absence of plaque; one third (1/3) of the surface shows plaque; two thirds (2/3) of the surface show plaque; more than 2/3 of the surface shows plaque Higher score means worse outcome.	0, 7, 21 days
Change in Calculus index (Volpe-Manhold index) (VMI)	Assessment of tartar on lingual surface of lower anterior teeth, expressed in millimeters. Three measurements are taken for each tooth; mesio-lingual, central lingual and disto-lingual. Total score is the sum of all measurements of all six lower anterior teeth. Higher score means worse outcome.	0, 7, 21 days
Change in Stain index (Macpherson stain index) (S.I.)	Assessment of tooth staining. Expressed via score and plus signs: 0-1 mild stains + 1.1 - 2 moderate stains ++ 2.1 - 3 heavy stains +++ Average stain value = sum of stain scores / total number of teeth Higher score means worse outcome.	0, 7, 21 days

Collaborators and Investigators

• Sponsor: University of Milan
• Collaborators: Azienda Farmaceutica Italiana s.r.l.
• Investigators: Principal Investigator: Chiara Occhipinti, Professor, University of Milan

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): June 22, 2020
• Study Completion (ANTICIPATED): June 30, 2020

Study Registration Dates

• First Submitted: June 6, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (ACTUAL): June 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Periodontal index
• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Gastrointestinal Agents; Anti-Ulcer Agents; Disinfectants; Chlorhexidine; Polaprezinc
• Other Study ID Numbers: COCMFFP-M-01-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No