Efficacy of Zinc L-Carnosine Mouth Rinse

Study Overview
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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

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.

Official Title
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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

Conditions
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Periodontal Index, Pain

Intervention / Treatment
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* Drug: Zinc L-Carnosine
* Drug: Chlorhexidine
* Other: Water


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zinc L-Carnosine mouth rinse<br>Using undiluted 10 ml of Zinc L-Carnosine mouth rinse, retain for 60 seconds, 3 times daily | Drug: Zinc L-Carnosine<br>* Undiluted 10 ml of Zinc L-Carnosine mouth rinse, retain for 3 minutes, 3 times daily<br>* Other names: Hepilor;|
| Active Comparator: Chlorhexidine<br>Using undiluted 10 ml of Chlorhexidine mouth rinse, retain for 60 seconds, 3 times daily | Drug: Chlorhexidine<br>* Undiluted 10 ml of Chlorhexidine mouth rinse, retain for 3 minutes, 3 times daily<br>* Other names: Curasept;|
| Placebo Comparator: Water<br>Mouth rinsing with 10 ml of water, retain for 60 seconds, 3 times daily | Other: Water<br>* Rinse mouth with 10 ml of water, retain for 3 minutes, 3 times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontal index, Pain