Efficacy of Zinc L-Carnosine Mouth Rinse

Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04430998
• Other study ID #: COCMFFP-M-01-2020
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2020
• Source: University of Milan
• Contact: Chiara Occhipinti, Professor
• Phone: +393339155689
• Email: Chiara.Occhipinti[@]unimi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: June 30, 2020
• Est. primary completion date: June 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Periodontal Index

Intervention

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

Other:
• Water
Rinse mouth with 10 ml of water, retain for 3 minutes, 3 times daily

Locations

Country	Name	City	State
Italy	UOC Maxillofacial Surgery and Odontology, University of Milan	Milan	Lombardy

Sponsors (2)

Lead Sponsor	Collaborator
University of Milan	Azienda Farmaceutica Italiana s.r.l.

Country where clinical trial is conducted

Italy, 

References & 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. Epub 2014 Dec 19. — View Citation

Löe H. Oral hygiene in the prevention of caries and periodontal disease. Int Dent J. 2000 Jun;50(3):129-39. Review. — View Citation

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. — View Citation

Tartaglia GM, Kumar S, Fornari CD, Corti E, Connelly ST. Mouthwashes in the 21(st) 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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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