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Version 1 2012-07-22 Research project - Pucyura 1. Title Comparative study on dental caries and periodontal disease in students of 12 to 18 years of age in Pucyura, Cusco, Peru, without prophylactic treatment, with prophylactic homecare and with prophylactic homecare plus professional control of the biofilm with Air!low Perio powder times per year. Summary The prevalence of caries and periodontal inflammation is high among the young population in
  Version 12012-07-22 Research project - Pucyura 1. TitleComparative study on dental caries and periodontal disease in students of 12 to 18 yearsof age in Pucyura, Cusco, Peru, without prophylactic treatment, with prophylactichomecare and with prophylactic homecare plus professional control of the biofilm withAir!low Perio powder times per year. Summary The prevalence of caries and periodontal inflammation is high among the young population in Peru. #o far no systematic prophylactic programs are in place for  prevention of dental diseases. The current pro$ect aims at %i& surveying the oral conditionsamong school children in Pucyura and %ii& evaluating the effects of disease prevention programs over a 'year period. #i(ty initially 12year old students will be offered carefulinstructions in effective oral hygiene %tooth brushing with a fluoridated toothpaste& withor without professional dental biofilm removal times per year until the age of 18 years.A new epidemiological survey will be performed after the ' years for comparing theefficacy of the prophylactic programs. 2. )nvestigators responsible for the trialProf. *osas Cisneros, +ugo eoncio, -ocente de niversidad Andina del Cusco, Peru,-epartamento Academico de /stomatologiProf. 0an  ennstrm, -ept of periodontology, )nstitute of 3dontology, #ahlgrens4aAcademy at niversity of 5othenburg, #weden-r. 6laus-ieter 7astendorf, -entist, /islingen, 5ermany %Practical instructor&3ther investigators-enisse *ivas 9uintanilla, -ocente niversidad Andina del Cusco, Peru..:. -escription of the problemAppro(imately ;8< of the Peruvian population suffers from dental caries and periodontaldiseases. This already starts with children and the latest official data available %publishedin 2==2 by the >alm niversity& revealed a ->!T of :.? for the age group 12 years. #ofar no systematic prophylactic programs are in place in Peru to prevent dental diseases.%@eed to e(pand the bac4ground by the Peru people& . 3b$ectives and PurposeThis study should prove that with prophylactic dental homecare caries and periodontaldiseases could be mar4edly reduced and that additional regular professional removal of dental biofilm further reduces the incidence of dental diseases. 1  Version 12012-07-22 . +ypothesis#ystematic and regular professional removal of oral biofilm with A)*!3 handy andA)*!3 Perio powder preventsBreduces the incidence of caries in children aged 1218years.'. Population sample and selection of trial sub$ectsClasses of students of secondary school in Pucyura, aged 1218 years, will be invited for an epidemiological survey of dental health conditions. The population sample willinclude a sample of at least 8= students aged 12 years, and at least = students of each 1year interval between 1: and 18 years. The 12year students will in addition be invited to participate in a 'year prospective trial on the efficacy of prophylactic programs. At theend of the 'year study period a new epidemiological survey comparable in design to theinitial one will be performed. '.1 #tudy design The epidemiological surveys %initially and after ' years& will comprise clinical andradiographic e(aminations with regard to presence of caries and periodontal diseases. Clinical examination The clinical e(amination will involve the following recordingsPermanent teeth presentTeeth with caries lesions D primary and secondary caries lesionsTeeth with fillings3ral hygiene conditions  scored as presenceBabsence of visible dental plaEue at surfaces %mesial, buccal, distal and lingual& of all permanent teeth. 5ingival inflammation D scored as presenceBabsence of gingival bleeding followingsuperficial probing of the gingival sulcus at sites %mesial, buccal, distal and lingual&of all permanent teeth. Probing poc4et depth %PP-&  assessed at all pro(imal sites with the use of a +3 probe and recording of teeth with PP-  mm and F' mm. !or description of the caries conditions -!>T %decayed, missing and filled teeth& scoreand -T score will be determined.  Radiographic examination !our bitewing radiographs, covering the distal surface of the canine to the mesial surfaceof the last molar will be ta4en. The radiographs will be analyGed for presence of primaryand secondary caries lesions e(tending into the dentin. !urthermore, an alveolar bonelevel located at a distance of H2 mm from the cementoenamel $unction will be recordedat all pro(imal tooth sites depicted on the bitewing radiographs. Questionnaire A Euestionnaire will be used for recording of general health conditions and oral hygienehabits. 2  Version 12012-07-22 '.2 Calibration of e(aminers7efore the start of the study and on a biannual basis training sessions will be arranged for calibration of the e(aminers. A reproducibility of F;=< for the various assessmentsshould be reached in order for the dentist to be Eualified as an e(aminer. A  periodontist of the niversity of 5othenburg will be responsible for the training and calibration sessions.'.: Treatment offered to participants in the epidemiological surveyAll sub$ects participating in the epidemiological survey will be offered treatment of acutecaries lesions. !urthermore, information and instruction will be given with regard to practicing good oral hygiene.'. Prospective longitudinal study of prophylactic programs8= students in the 12year age group will be included in prospective longitudinal study on prophylactic programs. )n case of more than 8= eligible students, the 8= students with thehighest ->!T scores will be selected for the study. The students will be randomlyassigned to the two programs. Self- and professionally performed prophylactic program = students will be carefully educated with regard to prevention of dental diseases. Theywill be provided with toothbrushes and fluoridated toothpaste for regular dentalhomecare. )n addition they will be treated at the niversity of Cusco by trained dentistsremoving the biofilm with A)*!3 devices and A)*!3 Perio Powder times per year until the students have reached the age of 18 years. 7efore the start of the trial ane(perienced dentist %-r. 6laus-ieter 7astendorf& will carefully train the dentist performing the treatment in the professional procedures. /very ' months during the entiretrial period the students will be provided with new supplies of toothbrush and fluoridatedtoothpaste. Self-performed prophylactic program = students will be carefully educated with regard to prevention of dental diseases. Theywill be provided with toothbrushes and fluoridated toothpaste for regular dentalhomecare. /very ' months during the entire 'year trial period the students will be provided withnew supplies of toothbrush and fluoridated toothpaste.  Reexaminations during the 6-year study period *ee(aminations with regard to oral hygiene standard will be performed annually. )f indicated reinforcement of oral hygiene procedures will be carried out. All students will have a complete ree(amination of caries and periodontal conditions after 2 , 8 and ?2 months. The ree(aminations include the same assessments as recorded at baseline %see above&. /ach sub$ect will be e(amined by the same dentist throughout thestudy. The e(aminers will not be involved in providing the treatment of the students andwill be mas4ed concerning the prophylactic group assignments throughout the study.)f new caries lesions are detected the students will be offered adeEuate treatment. :  Version 12012-07-22 ?. 3utcome variablesThe primary efficacy variables are -T and ->!T scores. #econdary outcome variablesare parameters describing periodontal conditions %gingivitis score and PP- categories&. The outcome data for the sub$ect groups receiving the prophylactic programs will becompared for efficacy evaluation with data for the various age groups of theepidemiological surveys performed at the start of the study and at the end of the 'year study period, respectively. 8. #tatisticsPower calculation based on the primary outcome variables revels that with an estimated potential reduction in caries incidence %-T score& of :=< with the prophylactic programscompared to the untreated population %epidemiological data& and with an α error of =.,:: sub$ects per group will be reEuired for a power of 8=< to detect a true difference.ith a potential ris4 of 2=< dropouts during the trial, = students per group will beincluded.;. Assessment of safetyThe procedures included in the clinical and radiographic e(aminations in this pro$ect areall wellestablished and worldwide used means in dentistry to assess dental diseases.3nly light pain during e(amination procedures may be e(perienced. Any ris4 for negativeeffects of the procedures involved in the prophylactic programs should not be e(pected based on evidence in the literature. +owever, if occurring any adverse signs andsymptoms will be recorded throughout the study. 1=. /thical considerationsThe study will be performed in accordance with the +elsin4i -eclaration and the protocolwill be submitted to the local ethic committee for human trials. 7efore the clinicale(amination the parents of the students will receive written information about purposeand content of the study and confidentiality. )n addition all students will receive oral andwritten information and informed consent will be obtained. The ma$or ethical issue relates to the selection of sub$ects to be included in thelongitudinal study. The 8= 12year sub$ects with the highest ->!T score will be offered participation in the prospective longitudinal study, which will secure that those in greatestneed of preventive treatment will receive adeEuate care. !urthermore, all students participating in the baseline epidemiological survey will be offered treatment of acutecaries lesions and provided information and instruction in oral hygiene measures. 11. #ignificanceThere is a lac4 of current data on dental health conditions among school children in Peruand particularly of Pucyura, Cusco. The proposed pro$ect will generate important dataregarding the prevalence of caries and periodontal disease in school children aged 1218years and how the conditions may have changed over a 'year period. )n addition, the benefit of dental prophylactic programs provided during a 'year period to schoolchildren
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