阳性对照英文

The fourth part of reduced tooth fungus spot and reduces the guminflammation the examination standard applicable scope: This standardis suitable to the appraisal and the confirmation includes the reducedtooth fungus spot and reduces the gum inflammation ingredient theproduct, including the toothpaste, rinses the saliva as well as otherproducts. Formulates literature and standard which this standardrefers: The reduced tooth fungus spot and reduces the gum inflammationthe clinical test one, the principle of equality 1. Includes the newactive constituent either the system product includes the new activeconstituent or the system reduced tooth fungus spot and reduces thegum inflammation the product merit effect by two independent clinicallaboratories confirmations. 2. includes clinical has confirmed theactive constituent product was included already clinical has confirmedthe reduced tooth fungus spot and reduces the gum inflammation activeconstituent or the system oral cavity nurses the thing the effect, maychoose the suitable gum inflammation patient, the confirmationincludes the same density active constituent to examine the productand the masculine comparison product 等效性, also should set up thenegative comparison or the placebo comparison group. 3. products (forexample toothpaste) includes differently, is possible when affects thereduced tooth fungus spot and reduces the gum inflammation activeexcipient (non- active constituent), its merit effect through clinicaltest confirmation. In 4. formulas the active constituent biology利用度 and the stability needs to provide the effective proof bythe applicant. Second, the research design (is stochastic andcomparison) generally should use method, the lamination, two unitsparallel observations clinical research technique blindly. Third, theexperimental deadline reduction tooth fungus spot and reduces the guminflammation the clinical laboratory to need the viewing time to belonger. Generally should be 6 months, at least carries on three timesof clinical examinations (baseline, 3 months, 6 months). Fourth,research object: For tallies trying brings into line with and removesthe standard to contract the gum inflammation the adult male and thefemale. The common each group completes experimental the crowdquantity to be supposed to be bigger than 30 people. Fifth, theinspection target or uses index 1. to be supposed to include therecognition the tooth fungus spot index and the reflection guminflammation degree target. Former including the tooth fungus spotcover area (for example by Turesky improvement Quigley & Hein PLI) orfungus spot thickness (Silness & L □e PLI), should observe 龈nearby the reason and the neighbouring surface fungus spot withemphasis. When selects the above target, should give the reason. Theuse gum hemorrhage index recording 龈 inflammation serious degree,may use BI (Mazza) or MBI, after also may use BOP% (namely to searchexamines has hemorrhage position spot to occupy the entire mouth totalposition spot %). Also may use by 龈 the edge and 龈 the nipple theshape color changes for the foundation index, like gum index (GI). Ifhas used the alternative means, these methods should have at least thesame sensitivity. 2. in principle should inspect and record entiremouth all toeet, each tooth inspects 6 units places (cheek 侧近center, cheek side central committee, cheek side far center, tongue侧近 center, tongue side central committee, tongue side is far) or 4units places (cheek side three units places and tongue side central).Not suitably uses represents the tooth (for example the Ramfjordtooth, the CPI tooth and so on). Sixth, the product provides and uses1. to receive examines

阳性的意思。这个POSITIVE是英文，表示是阳性的。说明你有过敏性疾病，你是属于过敏体质。平常需要避免接触那些容易引起过敏的物质。

牙菌斑:plaque (疾病及健康词汇: http://www.geocities.jp/ps_dictionary/medical2/102.htm)牙龈炎症gingivitis牙龈指数gingivitis index牙龈出血指数（bleeding index，BI）：检测标准testing standard适用范围Application scope牙膏toothpaste漱口水Mouthwash(Gargle, Dental water也可以的)制定本标准所参考的文献和标准Reference and criteria临床试验clinical trial活性成分Active Ingredients一般原则”（general principles）患者 suffers control对照随机randomization盲法(Blind Method)Stratified method分层功效应Effect口腔护理用品Oral & dental care Products阴性对照negative control阳性对照positive control赋形剂(excipitens).稳定性 stability生物利用度Biological Utilization药剂等效性, pharmaceutical equivalence安慰剂, placebo位点 site受试者subject成年男性和女性 male and female adults为符合纳入及排除标准的: 不能理解，抱歉，自己再改改吧！BOP Bleeding on probing颊侧buccal ridge舌侧lingualThe fourth part: Testing criteria of plaque reduction and gingivitis abating. Application scope: This criteria is applicable for the products for plaque reduction and gingivitis abating, including toothpaste, mouthwash and other products. Reference and criteria：Clinical trials of plaque reduction and gingivitis abatingFirst: General principles 1. The products containing new active ingredients or systems The effects of the products containing new active ingredients or systems for plaque reduction and gingivitis abating should be determined by two separate clinical trails. 2．The products containing the active ingredients determined by clinical trails The effects of oral & dental care products containing the active ingredients and systems determined by clinical trails for plaque reduction and gingivitis abating should be tested the equivalence between the products to be checked and the positive control products which contained the same concentration of active ingredients after choosing proper gingivitis suffers, and also should set up negative control or placebo control group. 3．The effects of the products (such as toothpaste) containing various excipitens（inactive ingredients）which may affect the activity of plaque reduction and gingivitis abating should be tested by clinical trails. 4．The biological utilization and stability of the active ingredients in the blend should be provided with available testimony by the applicant. Second: Research designs (randomization and control) Generally the blind method、the stratified method, and the dual-unit parallel observation are used as clinical research methods.Third: Testing periodThe period need for the clinical trails of plaque reduction and gingivitis abating is fairly long. Generally it should be six months, and three clinical check at least (baseline, three months, and six months).Fourth: Research objectives:The subjects should be male and female adults suffered from gingivitisGenerally the subject number should be more than 30 in a complete trail.Fifth: Checking index 1．The checking index should include acknowledged plaque index and the index which may reflect the gingivitis degree. The former includes plaque coverage (such as Quigley & Hein’s PLI modified by Turesky) or bacterium spot thickness (Silness & Löe’s PLI), stress on the observation of bacterium spots near and adjacent to the edge of the gum. If the above index is used, the reasons should be given. Record the degree of gingivitis expressed as bleeding index (BI) (Mazza), MBI, and BOP % (the percent of bleeding on probing sites to the total sites in the whole mouth after examination). The shape and color changing of gum edge and gum nipple could also be used as basic index, such as gingivitis index (GI). If other methods are used, they should have at least the same sensitivity as the above methods. 2．In principle, all the teeth in the mouth should be checked and recorded and six sites (Near-central of the buccal ridge, central of the buccal ridge, far-central of the buccal ridge, near-central of the lingual, central of the lingual, far-central of the lingual) or four sites (three sites of the buccal ridge and central of the lingual) of each tooth should be checked. The representative teeth shouldn’t be used(such as Ramfjord teeth, CPI teeth, etc).Sixth: Issue and application of products 1．The effective ingredients and concentration of the products to be checkedshould be the same as that of thepositive control products, other accessory ingredients should be the same or similar. Their appearance should be similar, if this requirement can not be achieve, then we can only fulfill the single-blind trail and issued the products by non-checkers.2. Tell the subjects about the using requirement and the attention. We should do quantification as possible, the dosage of toothpaste (such as 1 cm long, 10ml mouthwash or one cover of the bottle/time), applied times daily, duration etc. 3．The conditions should be kept identical as possible except for the testing products. If the subjects use the same toothbrush, their original brushing habits might be kept. For the following reasons: ① Even though they are taught the uniform methods, not always every person can grasp and abide them; ② we should make the experiment similar to various people in their natural lives.Seventh: Evaluation of effect1．According to medical stat. Method, we analyze the variation of the whole-mouth mean values of every index of the treatment group and the control group respectively before and after the tests, then analyzes the index variations during every period between the two groups. 2. The evaluation of the effect should be determined according to the mean value variation and block comparison of each clinical index. And all the values and stat. Results should be listed in the report, The subjective evaluated criterion should not be used alone（high effective, effective, little effective, non-effective）. In every clinical trail by comparison of the control group and the treatment group, every index reduction should meet the following conditions:[(Control-Treatment)/Control]≥15％。 3．The products for gingivitis controlling by reducing the amount of bacteric spots or change the disease caused by the bacteric spots should have significant difference.

positive control trains or positive bacteria

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.