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| Name | Class |
|---|---|
| Azienda Farmaceutica Italiana SRL | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinc L-Carnosine mouth rinse | Experimental | Using undiluted 10 ml of Zinc L-Carnosine mouth rinse, retain for 60 seconds, 3 times daily |
|
| Chlorhexidine | Active Comparator | Using undiluted 10 ml of Chlorhexidine mouth rinse, retain for 60 seconds, 3 times daily |
|
| Water | Placebo Comparator | Mouth rinsing with 10 ml of water, retain for 60 seconds, 3 times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc L-Carnosine | Drug | Undiluted 10 ml of Zinc L-Carnosine mouth rinse, retain for 3 minutes, 3 times daily |
|
| 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 |
| 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;
6 sites (3 buccal + 3 lingual / palatal) are considered for each tooth. Higher score means worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiara Occhipinti, Professor | Contact | +393339155689 | Chiara.Occhipinti@unimi.it |
| Name | Affiliation | Role |
|---|---|---|
| Chiara Occhipinti, Professor | University of Milan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UOC Maxillofacial Surgery and Odontology, University of Milan | Milan | Lombardy | 20122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25798271 | Background | 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. doi: 10.3892/mco.2014.479. Epub 2014 Dec 19. | |
| 10967765 | Background |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C061957 | polaprezinc |
| D002710 | Chlorhexidine |
| C010882 | chlorhexidine gluconate |
| D014867 | Water |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D006878 |
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| Chlorhexidine | Drug | Undiluted 10 ml of Chlorhexidine mouth rinse, retain for 3 minutes, 3 times daily |
|
|
| Water | Other | Rinse mouth with 10 ml of water, retain for 3 minutes, 3 times daily |
|
| 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
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 |
| Loe H. Oral hygiene in the prevention of caries and periodontal disease. Int Dent J. 2000 Jun;50(3):129-39. doi: 10.1111/j.1875-595x.2000.tb00553.x. |
| 27835926 | Background | Tartaglia GM, Kumar S, Fornari CD, Corti E, Connelly ST. Mouthwashes in the 21st 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. |
| 26427569 | Background | 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. |
| 20174833 | Background | 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. |
| Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |