Clinical trial NCT04430998: Efficacy of Zinc L-Carnosine Mouth Rinse
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Periodontal Index
Pain
Keywords: Periodontal index
Pain
Lead sponsor: University of Milan
Sponsor class: OTHER
Collaborators: name: Azienda Farmaceutica Italiana SRL
First posted: 2020-06-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Healing Index (H.I.)
timeFrame: 0, 7, 21 days
measure: Change in the Visual Analogue Scale (VAS) of pain
timeFrame: 0, 7, 21 days
Secondary outcomes:
measure: Change in Modified Sulcus Bleeding index (Mombelli) (mSBI)
timeFrame: 0, 7, 21 days
measure: Change in Full Mouth Plaque Score (O'Leary) (FMPS)
timeFrame: 0, 7, 21 days
measure: Change in Calculus index (Volpe-Manhold index) (VMI)
timeFrame: 0, 7, 21 days
measure: Change in Stain index (Macpherson stain index) (S.I.)
timeFrame: 0, 7, 21 days
Other outcomes:
Locations:
city: Milan
country: Italy
facility: UOC Maxillofacial Surgery and Odontology, University of Milan
state: Lombardy
Study officials:
affiliation: University of Milan
name: Chiara Occhipinti, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.