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MAXILLOFACIAL PROSTHETICSTEMPOROMANDIBULAR JOINT . DENTAL IMPLANTSSECTION EDITORSI. KENNETH ADISMAN LOUIS J. BOUCHER

Use of a saliva substitute in postradiation xemstmmiaRoy Y. Nakamoto, D.D.S., M.S.*Veterans Administration Medical Center, San Francisco, Calif.

U e of irradiation for oral malignancies leads tomany oral complications. A severe depression in therate of function of the salivary glands is one of thefirst and most annoying long-term complications.The decreased salivary flow is rapid in onset,pronounced, persistent, and irreversible. Dreizen, ina report on 42 patients with oral cancer who weregiven a tumor dose of 200 rads per day, 5 days perweek, through parallel opposed fields, showed theaverage flow rate in response to masticatory stimula-tion dropped 57% after the first week of therapy, 76%after 6 weeks of therapy, and 95% 3 years afterirradiation.

Shannon, in a report on 10 patients with primarymalignant lesions of the head and neck who weregiven 225 rads per day, 4 days per week, showed thatthe average flow rate of unstimulated whole salivahad been reduced 60% after the first week of therapyand 95% after 6 weeks o f therapy.

Decreased salivary flow causes significant changesin intraoral soft tissues. Oral and pharyngeal mucosadry very easily to the point of cracking and bleeding.This makes speaking, chewing, swallowing, andwearing prostheses difficult and painful. Eatingbecomes painful and maintaining proper nutritionduring this critical period of treatment and healing isextremely difficult.

Many different methods have been used to relievethe discomfor t associated with radiation-inducedxerostomia. Having the patient take frequent sips ofwater to quench thirst and lubricate the mouth is themost commonly used method. The relief is usually ofshort duration.

Read before the American Academy of Maxillofacial Prosthetics,Las Vegas, Nev.

*Chief, Maxillofacial and Removable Prosthodontic Sections.

BACKGROUNDDykes and associates3 developed a pastille contain-ing gelatine, glycerine, sucrose, lemon essence, sodi-

um benzoate, citric acid, amaranth solution, andwater. Patients with xerostomia used the pastilles onan ad libitum basis.

Robinson4 also prescribed the use of glycerin-based troches during waking hours. He also recom-mended a glycerin rinse before bedtime. The rinsewas made by combining half a bottle of proprietarymouth rinse with an equal volume of pure liquidglycerin.

Billingsley recommended frequent warm salinemouth rinses to moisten tissue and reduce hypersen-sitivity. She discouraged the use of astringent mouth-washes.

CarlG, used repeated warm saline and peroxiderinses to alleviate the discomfort from xerostomiaand mucositis.

Halpern recommended frequent use of blandmouthwashes. A solution of salt and soda rinsesprepared at home was used to help relieve thedifficulty in swallowing associated with xerostomia.

Fine had his patients rinse with diluted milk o fmagnesia or sodium bicarbonate to debride theepithelium and obtain relief where the mucosa wasdenuded. Temporary relief from xerostomia wasobtained by taking frequent sips of water or byrinsing with glycerin. In either case, frequent appli-cation was required.

Coffin, I advocated using a 1:20,000 chlorhexi-dine mouth rinse twice daily. Two hundred millilit-ers of solution was swished around for 30 seconds.Chlorhexidine is bacteriostatic to streptococci in thisconcentration, and the effect lasts for 12 hours. It canalso be used for months with no significant compli-cations.

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Fig. 1. Dry concentrate VA-Oralube.Matzker and SchreibeP prepared a synthetic

saliva with physical and chemical properties thatduplicated those of normal saliva as much as possi-ble. It had a pH of 7.2, and the main componentswere sorbitol (30%) and carboxymethyl cellulose. Intheir tests with 22 patients, 17 ml per day was themaximal volume required. All patients reportedconsiderable relief, and no significant side effectswere noted.

S-Gravenmade and associate? developed anartificial saliva made from a freeze-dried extract ofhomogenized bovine salivary glands. In a test with18 patients they found it superior to the Matzker andSchreiber synthetic carboxymethyl cellulose saliva,as it prevented formation of sticky masses on the softtissues. Only 3.5 ml per day were required, and relieflasted a mean of 2.5 hours.

Shannon14. I5 formulated a saliva substitute, VA-Oralube,* which served a dual purpose. It relievedVA-Oralube was developed by Dr. I. L. Shannon of the Veterans

Administration Oral Disease Research Laboratory and is usedexclusively by the Veterans Administration. It is presentlymarketed in the same formulation by two different companiesas Xero-lube (First Texas Pharmaceuticals, Inc., Dallas, Texas)and Orex (Kings Specialty Co., Fort Wayne, Ind.).

Fig. 2. VA-Oralube.

soft-tissue disorders associated with xerostomia, andit induced rehardening of softened tooth surfaces. Hehas reported highly promising results.

One of the problems with use of VA-Oralube hasbeen the packing and shipping of large quantities bymail. The packages were bulky and handling andmailing often resulted in damaged or spilled conta in-ers at the receiving end. High shipping costs werealso a factor. To help eliminate these problems,Shannon has now developed a dry concentrate formof Oralube that can be reconstituted 12 hours beforeit is needed.The purpose of this study was to determine theeffectiveness of the dry concentrate-derived Oralubein relieving oral soft tissue problems in postradiationxerostomia patients and to determine patient prefer-ence for either type of Oralube.MATERIALS

The saliva substitute known as VA-Oralube wasdeveloped primarily for use by patients undergoingradiotherapy for malignancy of the head and neck.The viscosity and electrolyte concentration (the

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VA-ORALUBE IN POSTRADIATION XEROSTOMIA

same relative concentration as in stimulated wholesaliva) has fluoride added to a concentration of 2ppm to promote rehardening of softened toothsurfaces.

Table I. Formula for VA-Or&be*

The formula in (Table I) includes potassiumphosphates, chlorides of potassium, sodium, magne-sium and calcium, sodium fluoride (2 ppm F),sorbitol, binder, flavoring, dye, preservative, andwater. Specific gravity is 1.0054 and pH is 7.0.

A dry concentrate form has now been formulated(Table II). The concentrate can be reconstituted bydissolving 35 gm in one-half gallon of water andletting it stand overnight. This product was made tohave the same characteristics and properties as thewet type except that the water has been eliminated.Remineralization potential is the same as for the wettype (Fig. 1).

KC1N&lMgCI,C&I,K,HPO+KH,PO,Methyl p-hydroxybenzoateNaFFD&C Red Dye No. 40 (2%)Flavoring70% Sorbitol (Sorbo)Na carboxymethylcelluloseWater, q.s. ad

2.498 gm3.462 gm0.235 gm0.665 gm3.213 qrn1.304 gm8.0 gm

17.ti8 mgm10 ml

16.0 gm171.0 gm40.0 gm

4000.0 ml*All ingredients are placed into a vessel and mixed with a T-LineModel 106 Stirrer with a 3-inch propeller. Mix for 8 hours. Noheat or blending is required.

METHOD Table II. Formula for VA-Or&be concentrate*Twenty-six postradiation head and neck cancer

patients were selected. Dentulous and edentulouspatients were included. Patients were randomlystarted on either wet- or dry-type Oralube. Thepreparation was dispensed in 4-ounce plastic squeezebottles fitted with rotating caps which can be turnedslightly to allow the patient to place any amountdesired between the lips without actually openingthe bottle cap (Fig. 2). Ad libitum use was stipulated,but patients were encouraged to use the solution onlywhen an actual intraoral need was felt. A demonstra-tion was given to each patient. The patients wereseen at 1,3,9, and 12 weeks from the start o f Oralubeuse. At each visit, a questionnaire was used to obtainsubjective responses regarding use and effectiveness(Fig. 3). After 12 weeks the patients were switched tothe other type of Oralube, and the evaluations weremade again at the same intervals.

KC1NaClMgCl, 6H,OCaCl, 2H,OK,HPO,KHZPO,Methyl p-hydroxybenzoateNaFFD&C Red Dye No. 40Powdered cheri-beriCarbowax

125 5-mI79 gm12 gm39 gm

I61 gm65 P200 gm

0.884 gm1.45 gm

700 gm2000 gm

*All components are passed through a Z&mesh screen and mixedwell in a large plastic container. The dry comxntrate is dispensedin 35 gm portions. A 35 gm portion is dissolved in water overnightto provide one-half gallon of VA-Oralube.

Table III. O ralube preference after &monthuse by 26 patients

PreferredWpt

Preferred Nodrv preferenceESULTS

After 6 months of use, clinical acceptance by 26patients was low for the dry Oralube and very highfor the wet Oralube (Table III). Two patients (7.7%)preferred the dry. Nineteen patients (73.1%) pre-ferred the wet. Five patients (19.2%) had no prefer-ence. Both wet and dry Oralube gave some relief to100% of the patients in this study. All patientsreceived immediate relief of intraoral soft tissueproblems. Those that had complained of a dry, sorethroat also reported consistent relief. The majorareas of consistent improvement were in speaking,swallowing, eating, and soreness. Many patientsfound Oralube useful during sleeping hours. Use of

No. of patients 19 2 5Percentage 73.1 7.7 19.2

Oralube before going to bed, and when awakened atnight, lessened the patients discomfort and made iteasier for them to rest.

Duration of relief varied from 30 minutes to 4hours between ad libitum applications. Dry Oralubegave the shortest duration of relief. Most patientswho did not like the dry Oralube noticed a differencein viscosity between the wet and dry Oralube. Thedry Oralube had a watery consistency.

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NAKAMOTO

Type of Oralube: Wet(Circle one)nite started:Date of visit: the week Three weeks Nine veeks Twelve weeks(Ctrcle one)Use of Oralube: NIL I-3/day 4-6 /day l-q/day lo-l?/day(Circle one)

kration of reliefUlcers

Camnents:

Name:Fig. 3. Evaluation questionnaire.

DISCUSSIONThe results of the present study confirm previous

studies on VA-Oralube. It is effective in controllingthe intraoral soft tissue complications of xerostomia.Although both wet and dry Oralube offer some reliefto all patients, the dry concentrate type needsimprovement before it can provide as much relief asthe wet type.

7.8.

Carl, W.: Oral care of patients irradiated for cancer of thehead and neck. Cancer 30:448, 1972.Halpern, I. L., and Freedman, A. L.: Dental managem ent ofthe irradiated patient. Dent Surv 51:18, 1975.Fine, L.: Dental care of the radiated patient. J Hosp DentPratt 9:127, 1975.Coffin, F.: The management of radiation caries. Br J OralSurg 11:54, 1973.Coffin, F.: The control of radiation caries. Br J Radio146:365, 1973.I would like to thank Dr. Ira L. Shannon, Director, Veterans

Administration Oral Disease Research Laboratory in Houston,Texas for his help and advice in reviewing the protocol andsupplying the materials used.REFERENCES

1. Dreizen, S., Brown, L. R., Daly, T., and Drane, J. B.:Prevention of xerostomia-related dental caries in irradiatedcancer patients. J Dent Res 56:99, 1977.

2. Shannon, I. L., Starke, E. N., and Wescott, W. B.: Effect ofradiotherapy on whole saliva flow. J Dent Res .56:693,1977.

3. Dykes, P., Harris, P., and Marston, A.: Treatment of drymouth. Lancet 2:1353, 1960.

4. Robinson, J. E.: Dental management of the oral effects ofradiotherapy. J PROSTHETDENT 14:582, 1964.

5. Billing&y, L.: Effects from radiation therapy of oral carci-noma. J Am Dent Hyg Assoc 45:305, 1971.

6. Carl, W.: Oral and dental care for the irradiated patient.Quintessence Int Dent Dig 5:55, 1974.

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Matzker, J., and Schreiber, J.: Synthetischer speichel zurtherapie der hyposialien, insbesondere bei der radiogenensialadenitis. 2 Laryng Rhino1 51:422, 1972.S-Gravenmade, EJ., Roukema, P.A., and Panders, A.K.:The effect of mucin-containing artificial saliva on severexerostomia. Int J Oral Surg 3:435, 1974.Shannon, I. L., McCrary, B. R., and Starke, E. N.: A salivasubstitute for use by xerostomic patients undergoing radio-therapy to the head and neck. Oral Surg 44:656, 1977.Shannon, I. L., Trodahl, J. N., and Starke, E. N.: Reminer-alization of enamel by a saliva substitute designed for use byirradiated patients. Cancer 41: 1746, 1978.

Reprint requests o:DR. ROY Y. NAKAMOTOVETERANS ADMINISTRATION MEDICAL CENTERDENTAL SERVICE4150 CLEMENT ST.SAN FRANCISCO, CALIP. 94121

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