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The aim of the study is to compare the effect of toothpastes containing thermal water of Castera-Verduzan with 1450 ppm fluoride and without fluorinated derivatives on oral hygiene, gingivitis, and dentin hypersensitivity in young adults.
This will be a double-blind, randomized, two-arm parallel-group study of the effect of toothpastes containing thermal water of Castera-Verduzan with 1450 ppm fluoride and without fluorinated derivatives. The groups will include adults with gingivitis and dentinal hypersensitivity (DH) diagnosed clinically. To assess the effect of the toothpastes, the following parameters will be used: gingival health (modified gingival index, MGI; gingival bleeding index, BI), dentin sensitivity (Shiff's index, VAS), oral hygiene level (Navi-Rustogi index), and salivary pH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - toothpaste containing thermal water of Castera-Verduzan and 1450 ppm Sodium fluoride | Active Comparator | Subjects will receive thermal water/sodium fluoride toothpaste (BUCCOTHERM® Sensitive Gums with Fluoride) |
|
| Group 2 - toothpaste containing thermal water of Castera-Verduzan | Active Comparator | Subjects will receive thermal water toothpaste (BUCCOTHERM® Sensitive Gums Fluoride-Free) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BUCCOTHERM® Sensitive Gums with Fluoride | Drug | Toothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums with Fluoride twice daily for 1 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of gingival inflammation by Modified Gingival Index (MGI) | MGI is used to assess visual symptoms of gingivitis on facial and lingual surfaces of each scorable tooth (whole mouth). Two scores are recorded buccally/labially, two scores lingually/palatally. Values are presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e., 0-4). Scoring is performed using standard dental light:0=absence of inflammation,1=mild inflammation;slight change in color,little change in color; little change in texture of any portion of the marginal or papillary gingival unit,2=mild inflammation; criteria as above plus the entire marginal or papillar gingival unit,3=moderate inflammation;glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit,4=severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit,spontaneous bleeding,congestion,or ulceration. Lower scores indicate better results. | 4 weeks after the baseline |
| Evaluation of gingival inflammation by Bleeding Inde | BI is used to assess bleeding elicited on probing as a measure of gingival condition. Gingivae are air dried and examiner assesses bleeding using a probe which is gently inserted into gingival crevice to depth of app 1 mm and run around tooth (angle of app 60 deg to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI is assessed on facial and lingual gingival surfaces of each scorable tooth (whole mouth). 3 scores are recorded buccally/ labially, 3scores lingually/ palatally. All scorable teeth in one quadrant are probed first (app 30 sec) before recording number of gingival units which bleed. Values are presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e., 0-2). BI score:0=no bleeding after 30 sec, 1=bleeding upon probing after 30 sec,2=immediate bleeding. Lower scores indicate better results. | 4 weeks after the baseline |
| Evaluation of DH according to Shiff sensitivity score | First, the tooth is isolated by the cotton roll from the adjacent teeth. Next, a blast of air from a standard dental unit syringe at 60 ± 5 psi at 18-22 °C is directed onto the exposed middle 1/3 buccal surface for 1 s at a distance of approximately 10 mm. Then, each patient reports the sensitivity he/she sensed using Schiff Cold Air Sensitivity scale scored from 0 to 3: score "0" means no response, score "1" means response without request of discontinuation of stimulus, score "2" means response with request of discontinuation of stimulus, and score "3" means pain with request of discontinuation of stimuli. Lower scores indicate better results. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of oral hygiene level according to Navi-Rustogi index | Nine sites per facial and lingual tooth surface are assessed, for a maximum 504 sites total (excluding 3rd molars, crowns, and surfaces with cervical restorations). Disclosed plaque is scored in each tooth area as follows: 0 = Absent; and 1 = Present. A mean plaque index (MPI) is calculated for each subject on a whole mouth basis. Lower scores indicate better results. |
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Inclusion Criteria:
Exclusion Criteria:
history of chemotherapy or radiotherapy
cervical area
of the subject to discontinue study participation
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| Name | Affiliation | Role |
|---|---|---|
| Irina M Makeeva | +79037280722 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Dentistry of Sechenov University | Moscow | 121059 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30346419 | Background | Makeeva IM, Polyakova MA, Doroshina VY, Turkina AY, Babina KS, Arakelyan MG. [Comparative effectiveness of therapeutic toothpastes with fluoride and hydroxyapatite]. Stomatologiia (Mosk). 2018;97(5):34-40. doi: 10.17116/stomat20189705134. Russian. | |
| 30199063 | Background | Makeeva IM, Polyakova MA, Doroshina VY, Sokhova IA, Arakelyan MG, Makeeva MK. [Efficiency of paste and suspension with nano-hydroxyapatite on the sensitivity of teeth with gingival recession]. Stomatologiia (Mosk). 2018;97(4):23-27. doi: 10.17116/stomat20189704123. Russian. |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D005459 | Fluorides |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 |
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double-blind, randomized, two-arm parallel-group study
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The allocation concealment will be performed using sealed containers numbered by a "third party" (person who will not participate in the study). The toothpastes in white bottles without any titles will be placed in the containers. Each patient will receive a sealed container with a toothpaste on enrolment. Neither patients nor researchers will be aware of the type of the toothpaste used.
| BUCCOTHERM® Sensitive Gums Fluoride-Free | Drug | Toothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums Fluoride-Free twice daily for 1 month. |
|
| 4 weeks after the baseline |
| 4 weeks after the baseline |
| Evaluation of salivary pH | Unstimulated 5 ml whole saliva sample is collected in morning from 10 am to 11 am, two hours after the last meal. Participants refrain from eating, drinking, smoking, or conducting oral hygiene procedures for a minimum of 90 min prior to salivary collection. Participants are comfortably seated, are asked to avoid swallowing saliva and asked to lean forward and spit all the saliva they produced into a graduated test tube until the required volume is collected. The pH is determined immediately after the collection using a digital pH-meter. | 3 minutes after baseline (after toothbrushing) |
| 35462739 | Background | Polyakova M, Sokhova I, Doroshina V, Arakelyan M, Novozhilova N, Babina K. The Effect of Toothpastes Containing Hydroxyapatite, Fluoroapatite, and Zn-Mg-hydroxyapatite Nanocrystals on Dentin Hypersensitivity: A Randomized Clinical Trial. J Int Soc Prev Community Dent. 2022 Apr 8;12(2):252-259. doi: 10.4103/jispcd.JISPCD_333_21. eCollection 2022 Mar-Apr. |
| D009057 |
| Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| Hydrofluoric Acid |
| D017611 | Fluorine Compounds |