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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
Toothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums with Fluoride twice daily for 1 month.
Toothbrushing using standardised technique and pear-sized amount of toothpaste BUCCOTHERM® Sensitive Gums Fluoride-Free twice daily for 1 month.
Institute of Dentistry of Sechenov University
Moscow, Russia
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.
Time frame: 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.
Time frame: 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.
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Time frame: 4 weeks after the baseline
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.
Time frame: 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.
Time frame: 3 minutes after baseline (after toothbrushing)