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! W C'-~ N y A TaE UNIVERSITY OF CHICAG'O' HOS'PITALS AND CLiN1i:.;S WALT'ER G' ZO1Lt'R MPMORIAL DENTAL CLINIC If0 s'xST iitn fTasZT CWICAC'O • ILLINOIS •01i79 •41-fft1 "di h"W.heai +M•oof June 27 % 1!48'33 rir. L. Pepples. :r. Vice President i'General Counsel 1600 W. Bil'li Stveet Louisville~, EY' k'021!0 ~~ Dear Mr. Pepples: .y. I have examined the interaction of the lip mucow, vith the, Actron fi'Strr in both normal amwking, and in the Philip Mlerris Puf'f' Prrameter. Ana1'yser (PPA). lefiore discussing my findingis, I believe it voulid be helpful to provide a brief explanation of anatomical variations in the oral areaa to better, understand (a) the mechanism of'smoking and'('b) how these variables can effect meaisureoents during experimental procedures. Firs!t, the reLationabip between the upper andllower jiaws r.rier among the population. Ebr the majority of the populatilon where the upper and lower jawa are in harmony, the Dental' Occlusion is known as a Cliass I Occlusion. When a discrepancy existr between the relationship of'upper to lower jaw, either a protrusive or retrucive occlusion of the tetth, is present. The protrusive occlusion ia, known as a Class IiII OcKlusion, and!a retrusive occlusion as a Class 11 Occlusion. These three classes of Dental Occlusion affect the sof't tissue profiles, .uscle t'one, lip path of closures in forming an oral seal and lip ptessures!. \ In addition to th~ese variations in upper/lower jaw relationships, anatomical variations in the lips themselves, e.g.. lip thickness. length, inter-labial tap, incompetent lips and muscle tone vi11 influente measurements vhen smoking a cigarette in a cumbersome device such as the PPA. The proximity, of the glass apparatus to the 11ipe, and its wei'ght,, result in, abnormal placement of' the filter in the lips and'abnorma3 lip preaaurea.

r . ' 1lr. E. Fepples Page 2 jnne 27, 1983 In puffing (or sucking) the orbicul'aris oris - a apbfiact+er-like, muscle inner'rated fzosi the YIIth craniial nerve, the facial ner.e, contracts to fora a seal a'roundi t'he filter. Dbvnvard~ movement of the lower Jaw thea forms a aegati've pressure, vhich enables smoke: iotake into the .outb4 Ila oormal amokiag;, there atsie subconscious cues which the smoker deroeLops4 Tba Vth or trigominal nerve is concerned with prnprioceptive sensation In the tongpe,,lips and to a lesser extent the teeth. ?his sensation, especially strong on the vexmiliiion border of' the lips and in, the fioaqrs',, In important for filter imsertibn, dbpth perception. In sswkin= with the PPA device, the Important role of the fingers isr l1ost. tinally, the nervous system connection betveen the!bigDer brain centers', klrputbalanl, indl facial nerve caA isduce behavioral effects on sKasurament' in an experimental awvfrendsrwS„ Prom this brief review of oral anatomy„ it ia clear that the PPA is a far fros ideal device for investigating Interactions between cigarette filters and the lip mucosa. ILts weight and design inbibi~t normal cigarette placeoent and pressures and'exacerbate effects of anatomical varlstions. Method tiberoptic examination is an accepted med'1ca1f aNetho&of obtaining panoramic vietring,of anatomical areas that are difficult to observe, e.s., nasopharynx, oropharyoac, laryngeal. oesophageal„ garric and Losilx satrointestinal tract. Dr. xeyoumars Soltani and I', tKerefore, decided to use panoraaic fiberoptic viewing interfaced with color ( videp camcraLtap' rwl..&, fp fna'U-a ya to obocrve the iuLetaLttUiU t oetween the liips aAd the barcLay filter end in, normal' and In PPA n4kta~. . 3arclay cigarette amokers„ recruited I'rom the general population, participated In these observational studfesl . Cornclusiio'nis are based on the fi'ndlings in twenty, smokers with different characteristics and ba clcgr ound's : &men - age 29-4'2 years (sean 33_S') 12 women - age 21i'-S7' years (mean 37.5) The fibarnrri#.- p)k-~%tograph3o, oyrftcm cong1lrttdi uf a Xvuon llgh[ aouYce, transmissioo bund'les and, high resb3uti!on endoscope 41 ea in diameter, Interfaced vith a color video csmera/[ape unit for recording.

Mr. E. Pepp3es page 3 June 27, 1983 e e Results The vleving, angle used vltb t'be fi!beroptic probe 1!s of' great SMportance in sxamining the f3lter-mucosal relationship. When we usedi a posterior viewing angle our vi~evgag o~t' the filter end and' the filiter-su!cosal relationship vas„obs`tructed'by the aucosal roll. Thus, posterior, vieuinj, does not allow closee examination of the filter end to, aucosal fold relationshi'p. Yet even from a posterior viev, when the lover lip ~a e__a__r~s to cover the filter end, smoke circulates: over the aucosall fo idI-, s~o.wing that the lip dioes not intimstely abut against the filter end. To iap€ove our observation of'the filter end to aucoaa2 fold relationship and the flow of' the smoke incra-orally, ve decided to uti'lise a lateral'vieving angle. Lateral angl'ed vieving made i'r possible to observe the Iaportant fi!lter-mucossl relationship, the fl'ov of smoke and patency of the vents. The lip roll to filter end, phenomenon without vent obstructi'on was visible~and'well demonstsated. tihile there is obviously great variation In smoking technique.amd anatomical st'ructures, particular3y the lips„ teeth and jaw positions. our oSx+T..rstioostn normal arnsr laqg with tllkoc 20, Darulay ltmokers did not demonstrate: occlusion, of the Action filter'r end openings. Ir:lthough, occasionally occlusion of one vent was observed, we never observed occlusion of tvo,, three or four vents. Be next used the same fiber optla equipnent to observe lip mucosa filter iate!ract'ions of subjects smoking Barclay In the PPA. This provides ai completely different picture. In ge'neral, increasedl wcosal coverage with occlusion of more than one vent vas observedi. For subjects with poor muscle tone, this phenomenon was enhanced. The decrea!aed'avai'lable surface area of the fi'1ter, when usi'ng,the device,, limits the insertion depth, thereby altering the 1!i'p to fllter'end relati'onship. This altered relariomship, toge2her with the. +tikwardness of the device „ behavioral influences, andlarti'ficial'ity of saoking affect the ventilation system of' the Barclay filter. The devica causes unfavorable abutment of the,lips behind't'he filter, +ngulaition of'the filter between the lips, iincreased base 11ne lip pressure, reactive ihvard pressure, and increased pressure directed' toyards the end of the f'ilter. -

Mr. S. pepplei LaS e a Jiuae 2'7, 1983 •1'tbouZb tbe fiber optic probe sap have hsd! so.e! effect on the aaoking~ behavior of these subjects, in .p profeas3;onal jnd`.eav, it did' not .ateri'atly inflkm!eoee tbe filter snd - lip interaction observed. Since all subjecta s.+oked with the probe in plaee,,the probe alone could not have eyused.the observed differences in smokiaS,vith and without the PPx. iFideotapes are available which sbov all'these effects. In concluaion. ay professional views based qnifiber opti'c viewing of the filter end - lipivucosal iateractiona are: . Most smokers do not occlude the vent openinSs of Actron Fi'lters. Qeclvaion, if it oceurs, involves only one vent opening. . The PPA device, rather than demonstratin` occlusi'oa of the vent openinSs, actually induces an uncharacteristic occlusion of the vent openings snd thus artificially reducess ventilation. Louis Pine"dOD.S., H.DWD. Associate Professor of MsxilLofxci'a1 Prostbodontics and Dental Surgery