Efficacy of Zinc L-Carnosine Mouth Rinse

University of Milan

Status and phase: Unknown; Phase 3

Conditions: Periodontal Index; Pain

Treatments: Drug: Chlorhexidine; Other: Water; Drug: Zinc L-Carnosine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04430998

COCMFFP-M-01-2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups, including a placebo group

Zinc L-Carnosine mouth rinse

Experimental group

Description:

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

Treatment:

Drug: Zinc L-Carnosine

Chlorhexidine

Active Comparator group

Description:

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

Treatment:

Drug: Chlorhexidine

Water

Placebo Comparator group

Description:

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

Treatment:

Other: Water