清影5127
The fourth part of reduced tooth fungus spot and reduces the gum inflammation the examination standard applicable scope: This standard is suitable to the appraisal and the confirmation includes the reduced tooth fungus spot and reduces the gum inflammation ingredient the product, including the toothpaste, rinses the saliva as well as other products. Formulates literature and standard which this standard refers: The reduced tooth fungus spot and reduces the gum inflammation the clinical test one, the principle of equality 1. Includes the new active constituent either the system product includes the new active constituent or the system reduced tooth fungus spot and reduces the gum inflammation the product merit effect by two independent clinical laboratories confirmations. 2. includes clinical has confirmed the active constituent product was included already clinical has confirmed the reduced tooth fungus spot and reduces the gum inflammation active constituent or the system oral cavity nurses the thing the effect, may choose the suitable gum inflammation patient, the confirmation includes the same density active constituent to examine the product and the masculine comparison product , also should set up the negative comparison or the placebo comparison group. 3. products (for example toothpaste) includes differently, is possible when affects the reduced tooth fungus spot and reduces the gum inflammation active excipient (non- active constituent), its merit effect through clinical test confirmation. In 4. formulas the active constituent biology and the stability needs to provide the effective proof by the applicant. Second, the research design (is stochastic and comparison) generally should use method, the lamination, two units parallel observations clinical research technique blindly. Third, the experimental deadline reduction tooth fungus spot and reduces the gum inflammation the clinical laboratory to need the viewing time to be longer. Generally should be 6 months, at least carries on three times of clinical examinations (baseline, 3 months, 6 months). Fourth, research object: For tallies trying brings into line with and removes the standard to contract the gum inflammation the adult male and the female. The common each group completes experimental the crowd quantity to be supposed to be bigger than 30 people. Fifth, the inspection target or uses index 1. to be supposed to include the recognition the tooth fungus spot index and the reflection gum inflammation degree target. Former including the tooth fungus spot cover area (for example by Turesky improvement Quigley & Hein PLI) or fungus spot thickness (Silness & L e PLI), should observe nearby the reason and the neighbouring surface fungus spot with emphasis. When selects the above target, should give the reason. The use gum hemorrhage index recording inflammation serious degree, may use BI (Mazza) or MBI, after also may use BOP% (namely to search examines has hemorrhage position spot to occupy the entire mouth total position spot %). Also may use by the edge and the nipple the shape color changes for the foundation index, like gum index (GI). If has used the alternative means, these methods should have at least the same sensitivity. 2. in principle should inspect and record entire mouth all toeet, each tooth inspects 6 units places (cheek center, cheek side central committee, cheek side far center, tongue center, tongue side central committee, tongue side is far) or 4 units places (cheek side three units places and tongue side central). Not suitably uses represents the tooth (for example the Ramfjord tooth, the CPI tooth and so on). Sixth, the product provides and uses 1. to receive examines the product and the masculine comparison product should include the same active principle and the density, other supplementary materials and so on become the duty same or are similar. The outside wrapping and the outward appearance should be same, if cannot meet this requirements, then only can implement the list blind experiment, provides the product by the non- inspector. 2. to receives the trying explanation operation requirements and the matters needing attention. Achieves as far as possible quantitative, the toothpaste each time amount of use (for example paste body length is 1 centimeter, contains rinses fluid each time 10ml or a bottle cap and so on), the unification uses the number of times every day, the duration and so on. 3. should maintain as far as possible besides the confirmation product the condition is consistent, if possesses the trying use same toothbrush, but may maintain the trying original custom is cleaned the teeth the method. Because (1) even if teaches to unify the method, the uncertain each person all can very good grasp and observe; (2) Causes the experiment comparatively to conform to in the real life the different crowd's situation. Seventh, the effect appraises 1. to press the medicine statistical method, to experiments the group and around the comparison component other statistics experiment each target entire mouth average value change situation; And carries on two groups of between each o'clock compartment, various targets change statistics analysis. 2. The effect evaluates should based on each clinical target average value change and the group quite definite, reported should list each value and statistics result, not the suitable pure use from draws up four levels of evaluation criterias (show results, effectively, progressive, are invalid). In each clinical research, the comparison group and the experimental group compare, each target reduction should satisfy the following condition: [ (Comparison - experiment)/comparison ] >= 15%. 3. controls the gum inflammation through the reduced fungus spot quantity either the change fungus spot pathogenicity the product to be supposed to determine the fungus spot quantity the reduction or pathogenic decreasing, and has statistics difference.
水果西瓜太郎
Part IV reduce inflammation of the gums behind and mitigation standards Application : The standards applicable to the assessment and certification contain enough to reduce inflammation and alleviate inner components of products including toothpaste, wash water and other products. The enactment of this standard reference literature and standards : Ability to reduce inflammation and alleviate Most clinical trials First, the general principles 1. Containing new active ingredients or product system Containing new active ingredients or systematic enough to reduce inflammation and alleviate back the efficacy of products should be two independent clinical testing certification. 2. Has been tested to contain the active ingredient clinical products Clinical containing has been tested to reduce plaque and periodontal inflammation active ingredients or reduce the system's effectiveness oral care supplies, choose appropriate Yakenyan patients, the certification contain the same concentration of active ingredients imported products and products with the equivalent of positive, but also negative in the establishment of a control group or placebo. 3. Products (such as toothpaste) containing different, may affect ability to reduce inflammation and alleviate Most of the 237,448 active (non-reactive components), its effectiveness through clinical testing certification. 4. Biological active ingredients, recipes and stability needed for use by the applicant to provide effective proof. Second, the research design (random and compare) General law should be applied blind, stratified, two units parallel observation clinical research methods. Third, the duration of the pilot Ability to reduce inflammation and alleviate Most clinical trials required to observe longer. Normally be for six months, at least three clinical examination (baseline, three months, six months). 4, the study : Applying the exclusion criteria and to meet with Yakenyan into adult male and female. General group completed pilot groups should be greater than the number 30. 5, inspection or use indicators index 1. Should include recognized easily index and the indicators reflect the degree of periodontal inflammation. The former includes enough coverage (such as from the Turesky improved Quigley & Hein PLI) or Junban thickness (Silness & L ö e PLI), the focus should be observed near the gums and neighbors face the fate Junban. In selecting the above-mentioned indicators, should be explained and justified. Use the index recorded Kenyan bleeding gums extent of available BI (controls) or MBI, also available BOP% (mine up the place after a bleeding point total population% of the total spaces points). May also be used to bite and bite at the nipple changes colour patterns based index, such as the ability index (GI). If the use of other methods, these methods should have at least the same sensitivity. 2. In principle, there should be checks and records all around the mouth of teeth, dental check every six spaces points (adjacent to the mouth, cheek side of the central and lateral entry far, nearly broke side, adjacent to the tongue, tongue side far), or four spaces points (adjacent to three entry points and places adjacent to the tongue). Inappropriate use of teeth (as Ramfjord teeth, CPI teeth, etc.). 6, the issuance and use of products 1. Quick comparison of products and positive effective products should contain the same concentration of ingredients and other textiles, and other elements should be identical or similar. Overpack and appearance should be similar, if not achieved this requirement, then only a single blind testing by the inspection of non-payment products. 2. To the degree that use requirements and attention matters. As far as possible quantitative, toothpaste every usage (such as the length of one Gaoti centimeters, or one 10ml bottle each Hanshu fluid, etc.), daily use of uniform frequency, duration, etc. 3. In addition to the certification of products should be maintained outside the terms agreed, as all use the same toothbrush degree, but can maintain the original degree Brushing habits. First, because even with the uniform methodology, not necessarily good person can grasp and compliance; Second, to test a more realistic life different groups. 7, the evaluation results 1. According to the medical statistical methods to test and control groups, respectively, the indicators of statistical tests and the entire population mean changes; And the time between the two groups, and changes in the statistical analysis of the indicators. 2. Results of the assessment should be based on the clinical indicators and distance changes between the comparative group identified, the report should include the value of statistics and the results should not simply be used from the 4 evaluation criteria (soil, effective, progress, invalid). In each clinical research, testing group compared with a control group, the target should be reduced to meet the following conditions : [(contrast-test) / contrast ]=15%. 3. By reducing the volume or change Junban Junban pathogenic inflammation of the gums and control products should be reduced or volume measurement Junban reduce pathogenic nature, and have statistical differences. 不晓得准不?
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