AzTrials
AzTrials

Periodontal IndexPhase 3NCT04430998

Efficacy of Zinc L-Carnosine Mouth Rinse

A Phase 3 study testing Zinc L-Carnosine, Chlorhexidine and Water in people with Periodontal Index and Pain, run by University of Milan at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Periodontal Index, Pain
What is being tested?
Zinc L-Carnosine, Chlorhexidine and Water
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
1 siteItaly
Study dates
Jun 2020to 30 Jun 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Chiara Occhipinti, Professor contact

+393339155689

Chiara.Occhipinti@unimi.it

Italy1 site

  • UOC Maxillofacial Surgery and Odontology, University of Milan

    Milan, Lombardy, 20122

Other trials in Italy

About this study

Official title: 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

Read the 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.

Being tested
Zinc L-Carnosine, Chlorhexidine, Water
Keywords
Periodontal index, Pain
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zinc L-CarnosineDrug

    Also called Hepilor

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

  • ChlorhexidineDrug

    Also called Curasept

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

  • WaterOther

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

Study groups in NCT04430998
Study groupRoleWhat they receive
Zinc L-Carnosine mouth rinseExperimentalUsing undiluted 10 ml of Zinc L-Carnosine mouth rinse, retain for 60 seconds, 3 times daily
Receives: Drug: Zinc L-Carnosine
ChlorhexidineActive comparatorUsing undiluted 10 ml of Chlorhexidine mouth rinse, retain for 60 seconds, 3 times daily
Receives: Drug: Chlorhexidine
WaterPlacebo comparatorMouth rinsing with 10 ml of water, retain for 60 seconds, 3 times daily
Receives: Other: Water

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 0, 7, 21 days

  2. 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.

    Measured: 0, 7, 21 days

Secondary outcomes (4)

  1. 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;

    1. presence of bleeding on probing without redness and edema;
    2. presence of bleeding on probing with redness and edema;
    3. spontaneous bleeding.

    6 sites (3 buccal + 3 lingual / palatal) are considered for each tooth.

    Higher score means worse outcome.

    Measured: 0, 7, 21 days

  2. 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

    1. one third (1/3) of the surface shows plaque
    2. two thirds (2/3) of the surface show plaque
    3. more than 2/3 of the surface shows plaque

    Higher score means worse outcome.

    Measured: 0, 7, 21 days

  3. 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.

    Measured: 0, 7, 21 days

  4. 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.

    Measured: 0, 7, 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study startJun 2020 (estimated)
  3. Primary completion22 Jun 2020 (estimated)
  4. Study completion30 Jun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04430998
Sponsor's protocol ID
COCMFFP-M-01-2020
Status last verified
Jun 2020
First submitted
6 Jun 2020
Last updated
18 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 25798271

  • 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.

    PubMed 10967765

  • 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.

    PubMed 27835926

  • 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.

    PubMed 26427569

  • 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.

    PubMed 20174833

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zinc L-Carnosine, Chlorhexidine and Water in people with Periodontal Index and Pain, run by University of Milan at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chiara Occhipinti, Professor (+393339155689, Chiara.Occhipinti@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Healing Index (H.I.) (time frame: 0, 7, 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04430998, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in