Efficacy of Zinc L-Carnosine Mouth Rinse

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2020-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Periodontal Index Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Zinc L-Carnosine mouth rinse

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

Group Type EXPERIMENTAL

Zinc L-Carnosine

Intervention Type DRUG

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

Chlorhexidine

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

Group Type ACTIVE_COMPARATOR

Chlorhexidine

Intervention Type DRUG

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

Water

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

Group Type PLACEBO_COMPARATOR

Water

Intervention Type OTHER

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

Interventions

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Zinc L-Carnosine

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

Intervention Type DRUG

Chlorhexidine

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

Intervention Type DRUG

Water

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

Intervention Type OTHER

Other Intervention Names

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Hepilor Curasept

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes