(lin Ora pt Rex 198: 7: 387-346 Printed in Demnark. Al rights reseed Copsright © Munksgaard 1996 CLINICAL ORAL Ca Non-submerged implants in the treatment of the edentulous lower jaw A 2-year longitudinal study Astrand P, Almfeldt I. Brunell G, Hamp S-E. Hellem S. Karlsson U, Non-submerged implants in the treatment of the edentulous lower jaw. A 2-year longitudinal study. Clin Oral Impl Res 1996: 7: 337-344, © Munksgaard, 1996 Non-submerged ITI Bonefit implants (ITI Dental Implant System) were inserted in edentulous lower jaws of 46 patients. The patients were provided with either a fixed prosthesis or an overdenture, and has been followed during a 2-year-period. At the |-year examination, the suprastructures ‘were removed permitting test of the individual implant stability, Radio- graphic examinations were performed in connection with the loading of the implants and at the I-year examination. In total 216 implants were inserted. 4 implants were lost before loading and 4 during the 2nd year of function, which gives a survival rate after 1 year of 98% and after 2 years of 96%. The mean marginal bone loss during the first year of function was 0.1 mm. However, the marginal bone changes had a high degree of variation and four implants showed a severe bone loss. The intention is to P.Astrand!, |. Almfeldt®, G.Brunell®, S.-£. Hamp?, S.Hellem' and U. Karlsson? Department of Oral and Maxillofacial Surgery, Univesity Hospital Linképina, “Department of Prosthodontics, Norrkoping and *Depariments of Periodontology and Prosthodontics, Motala, Specialist Dental Services in Ostergbiland, Sweden Key words: osseointegrated implants — nonsubmerged implants — longituinal study ~ marginal bone change Per Astrand, The University Hospital follow this patient group with annual examinations during 5 years. Progress in the field of implant treatment during the last couple of decades has been rapid. One rea- son is the publications written by Brénemark et al (Branemark et al. 1969, Adell et al. 1981) on the concept of osseointegration. Among the prerequi- sites for osseointegration given by Brdnemark et al, (1969) is that there is “Primary closure of the fixture site from the oral cavity until the barrier function of the tissue has been recovered after the operation”. This means a two-step procedure: first insertion of the intra-bony part of the implant and then, after proper healing time, the connection of a soft tissue penetrating part of the implant This 2-stage concept (submerged technique) has been used by many manufacturers of implant sys- tems, eg., the Branemark system (Branemark et al. 1985), the IMZ implant system (Koch 1976. Kirsch & Ackermann 1989). the Astra Tech im- plant system (Arvidson et al. 1992) and Core-Vent implants (Niznick 1982). However, one-stage sys- Department of Oral & Maxilofacal ‘Surgery, $-581 85 Linképing, Sweden Tel. 46 13 22 85 66, Fax: 4613 22 85 65 ‘Accepted for publication 20 April 1996 tems permitting the implant to penetrate the soft tissues at insertion (non-submerged technique) have also been presented, e.g. Frialit (Schulte & Heimke 1976), Sapphire implants (McKinney & Koth 1982, Fartash et al. 1995), the TPS-screw (Ledermann 1979), and the ITI Hollow Cylinder implants (Lederman & Schroeder 198]. Sutter et al. 1983, Buser et al. 1988. Sutter et al. 1988, Schroeder et al. 1988). ‘One advantage attributed to the submerged technique is that healing takes place separated from the oral microbiological environment and that the implant is unloaded during this period. Advantages of the non-submerged technique are the need for only one surgical procedure and no subgingival micro-gap between implant and abut- ment. It has also been claimed, that the soft tissue integration will be better maintained without a sec- ond surgical procedure. Several experimental studies have been pub- 337Astrand et al. lished concomitant with continuing debate as to whether the submerged or the non-submerged technique is preferable, (Fiorellini et al. 1992, Weber et al. 1995, Gotfredsen et al. 1990, Lisigart- enet al. 1991). These studies clearly demonstrate that osseointegration can also be achieved with a non-submerged technique. The clinical results of implant treatments have been studied in a number of longitudinal investi- gations. So far, the best documented implant sys- tem is the Brénemark system (Adell et al. 1981, Adell et al. 1990), which is a system based on the submerged technique. Regarding the non-sub- merged systems, few longitudinal studies covering long observation periods and sufficient numbers of patients have been presented and the documenta- tion must, from a clinical point of view, be re- garded as still not conclusive. The aim of the pres- ent investigation was to study the early and long- term results of a non-submerged implant system. In this paper, the one and two-year follow-up re- sults will be presented and discussed. Material and methods The material consists of 46 consecutively treated patients, 25 female and 21 male, who were admit- ted to the study between March 1991 and Sep- tember 1992. Patients aged between 20 and 70 years were eligible. The mean age of the group was 57.7 years (Table 1). Bone quantity and quality were classified according to Lekholm & Zarb (1985), Most patients had a resorption corre- sponding to score B och C and an estimated bone quality of 2 or 3 (Table 2), Choice of treatment with either a fixed pros- thesis or an overdenture (Table 3) was made ac- cording to the decision and wish of the patient Economic reasons were predominant for the choice “Table 1. Age and sex distribution ofthe patients ‘Age years) 40-60 51-60 61-70 Teal male 6 10 5 2 fermale 5 6 4 25 total "1 16 19 6 “Table 2. Bone quantity and qualty ofthe patents according to Lekholm & Zarb (1985) Bone quantity A 8 c bd €E no. patents 3 on om 8 Bone qualty 1 2 3 4 9 1. patents 2 8 7 338 ‘able 3. umber of bridges and overdentures according to sex and age Bridges verdentures mae female mae ‘female 10. 8 15 8 10 age (ears) (Erange) $5.9 (44-68) 562 (40-68) 55.5 (43-67) 60.3 (44-70) of an overdenture. The implants used in the study were Bonefit two-part hollow screw implants with a length of 8-16 mm (ITI Dental Implant System) In each patient, 4-6 implants were inserted, allto- gether 216 implants. The distribution was 5 pa- tients with 6 implants, 22 patients with 5 implants and 19 patients with 4 implants, Surgical procedure An intraforaminal_mideristal incision was made and full-thickness flaps reflected buccally and Iin- gually. The crest was slightly flattened when needed. 4 implants were inserted in patients de- manding an overdenture while patients demanding fixed bridges were supplied with 5 or 6 implants. The fixture site was prepared according to the rec- ommendations of the manufacturer and done under rigorous irrigation. The fixtures were closed with cover screws and the soft tissues closed tightly around the fixtures with sutures, left in for 10 days Prophylactic antibiotic therapy was given and con- tinued for 10 days. Prosthetic procedure 2 weeks after surgery, the dentures were re-inserted after being adjusted in the implant areas and re- lined with a tissue conditioner (Visco-Gel®). The temporary relining was replaced every 5-6 weeks during @ healing period of 3 months. Afier the healing period, standardised secondary parts of the ITI Bonefit implants (6°, 8° or 15°) were in- serted.The implants were loaded with the perma- nent prosthetic reconstruction about 4 months postoperatively. The framework of the bridges was made of a gold alloy. Occlusal surfaces and facings were made in acrylic. All bridges were made with a freedom in centric of at least 1 mm. Strenuous efforts were made to achieve balanced occlusion. In cases of overdentures, prefabricated gold caps made of non-oxidising alloy were used together with a2 mm non-resilient bar. In each overdenture, 2-4 JS-retainer bar clips were used. The prostheses were reinforced with a metal frame of Cobolt- Chrome alloy (Vitallium®).Follow-up All patients have been monitored according to the research protocol. Clinical data, including implant stability, plaque accumulation, bleeding on prob- ing of peri-implant mucosa, pocket depth and presence of attached mucosa, were recorded at the delivery of the fixed or removable prostheses (base line recording), and at the 1-year and 2-year fol- low-up examinations.At the i-year follow-up, an additional examination of implant stability was made with the Periotest (Siemens, Bensheim, Ger- many) device (d'Hoedt et al. 1985, Derhami et al. 1995, Mericske-Stern et al. 1995). At these exami ations, the suprastructures were removed. Oral hy- giene instructions and professional dental cleaning by a dental hygienist were repeated at intervals of 6 months. Radiographic examinations including panoramic and intraoral radiographs were per- formed at the baseline examination and at the Fig. J. The bone level adjacent to the implants was evaluated bby measuring the distance from the crownvimplant junction to the most coronal point where the marginal bone meets the im- plant surface, Measurements were made at the base line exam- ination (@?) and at the I-year examination (a) Non-submerged implants in the lower jaw Fig. 2. Bridge supported by 6 implants at the base-line examin- ation (A) and at the I-year examination (B, C). The supracon- structions were removed to check the stability of the implants, L-year follow-up. The intraoral radiographs were taken with a long cone technique and used for the evaluation of the marginal bone level. ‘The marginal bone level was measured as the distance from the implant/crown border (Fig. 1) to the most coronal point where the marginal bone met the implant, A Peak scale loup with a magnify- ing factor of x7 and a scale graduated in 0.1 mm was used and the measurements were made at the mesial and distal surfaces. All measurements were made independently by 2 of the authors (SH and PA). If there was a discrepancy of 0.5 mm or less be- tween the observers, the mean value of the 2 mea: urements was used. In cases with greater’ obser- vation discrepancies, the measurements were re- peated and discussed until consensus was reached. Results Early healing period The surgical installation of the implants did not meet any difficulties, Fracture of the bone core oc- 339Astrand et al. curred frequently (38% of the implant sites), how- ever, either during the preparation with the tre- phine or when using the tapping device. The adap- tation between the peri-implant mucosa and the implant, recorded ten days postoperatively, dis- played slight dehiscences in 19 of the 216 implants. In all patients but one these dehiscences healed without complications. 4 implants were lost before loading. One patient lost 3 implants afier flap dehiscence and one patient lost 1 implant shortly after surgery. In the first patient, the prosthetic procedure hid to be postponed until new implants had been inserted. In the other patient the implant was not replaced. The survival rate before loading was 98%. Bone core fracture during the implant installation did not affect the loss of implants ‘year results 45 patients passed the 1-year follow-up. One pa- tient (provided with 5 implants) did not attend the follow-up examination. Stability of implants. All supraconstructions were removed and the individual stability of the im- plants checked (Fig. 2). The examination was made both manually and with the Periotest. All implants examined (207) were stable when tested manually. The Periotest showed negative values for all patients but one. The mean value of the Pe otest was —0.4. 1 patient had positive Periote values at 3 of her 5 implants and these values could later be correlated to a greater bone loss.The 1- year survival rate was 98%, Supporting tissues. At examination of the peri-im- plant mucosa nonattached mucosa was found buc- cally or lingually at 8% of the implants. A pocket depth of >4 mm was found at 5.2% and bleeding on probing at 12.4% of the implants surfaces. In very few cases were mucosal hyperplasias recorded (Table 4). Radiographic evaluation of the marginal bone level and bone level changes was made on intraoral radiographs. At the baseline examination, radio- graphs were obtained of 212 implants. 2 of these radiographs were excluded due to insufficient qual- ity, At the I-year examination, corresponding con- ditions were found at three of the 207 implants. ‘The mean marginal bone level was at the baseline examination located 3.8 mm apical of the implant crown border and at the 1-year examination the corresponding distance was 3.9 mm (Fig. 3). Thus, the difference between the examinations indicated a bone loss of 0.1 mm. This difference was not statistically significant. However, the marginal 340 Observation time 1 2 3 Years an Fig. 3. Mean marginal bone level and standard deviation re- Tated to the implant at the base line and I-year examinations, bone changes had a great variation, from +1.5 mm to —3.7 mm. At 155 implants, the change of the bone level was in the interval between +0.5 and 0.5 mm (Table 5). At 20 implants, there was a gain in bone level of more than 0.5 mm, and at 29 implants there was a bone loss of more than 0.5 mm. At 3 implants, the bone loss was >2.5 mm. 3 of these implants belonged to the same patient. 2-year results The 2-year follow-up comprised a clinical examin- ation only. Fortyfour patients passed this examin- ation (one patient was still not cooperative and one patient had moved out of the area). Stability of implants. In addition to the implant failures described above, another four implants were lost. They all belonged to the same patient, Table 4, Recording at the 1- and 2-year follow-up year 2 years bleeding on probing 124143 pocket depth >4 mm 52 155 Plaque andforcalcus 204382 nowatached mucosa Bo 78 mucosa hyperplasia 1819 Bleeding on probing and pocket depth >4 mm in per cent of implant surfaces (4 sutaces/mpant), Plaque accumulation, presence of nena tached mucosa hyperpasias in %e per implant. “Table 5. Number of implants with cffrent degrees of marginal bone anges between the baseline and 1-year examinations Bone Bone change Bone loss qin 05mm 05-15mm 125mm >25mm 20 155 8 8 3Fig. 4, Patient with great bone loss. Intraoral radiographs at the completion of the prosthetic treatment (A), at the year examination (B) and 10 months later (C). In this patient four implants was later removed. who at the I-year examination was found to have a severe marginal bone loss. The bone loss reached the vents of the implants and they were therefore regarded as failures and were surgically removed. No other implant failures were recorded. The sur- vival rate at 2 years was 96.2%, Supporting tissues. The plaque and calculus ac- cumulation had increased and so had the number of surfaces with bleeding on probing (Table 4). No radiographic examination was preformed at the 2- year examination. Discussion The patients treated in this study were consecu- tively included. They were all edentulous in the mandible and had different degrees of bone re- sorption and bone quality. The prerequisites for implant treatment were therefore probably similar to those of other patients with endentulous lower jaws routinely treated. All patients but 2 could be followed throughout the 2-year period. It may be of interest to scrutinise some of the failing implants of this study. The survival rate is to a great extent influenced by the outcome of the treatment of two patients. One of the patients, who lost implants before loading. had an early dehis- cence between the flap and the implants. This pa- tient had been edentulous in the lower jaw for Non-submerged implants in the lower jaw many years but not used any denture. She was ac- customed to chewing most kinds of food against the alveolar crest. The reason for the dehiscen and the failure of three of her implants was there- fore probably trauma. These three implants were later replaced. They all integrated and are now in- cluded in a fixed bridge. The other patient lost her implants after load- ing. The early healing period of this patient was free of complications and her implant-supported bridge functioned well. The radiographic examin- ation (Fig. 4), however. showed at the T-year exam- ination an advanced bone loss adjacent to 4 of her implants. The bone loss progressed during the fol- lowing year and reached the vents of the implants. These four implants were then removed. Several factors may be involved in bone loss. The reason for the severe bone loss in this patient is difficult to elucidate. This patient had earlier had_peri- codontitis which had been treated for years without success. It may also be of interest that this patient isa heavy smoker and smoking has been claimed to influence the prognosis of implants negatively (Bain & Moy 1993, de Bruyn & Collaert 1994), It has been questioned whether variables tra- ditionally used in the evaluation of periodontal conditions, e.g., bleeding on probing and probing pocket depth, are relevant in a corresponding evaluation of peri-implant tissues. Recent research by Lindhe and coworkers (Berglund ct al. 1991. Ericsson & Lindhe 1993) shows that differences between the supporting tissues make the con- ditions for probing depth measurements at teeth and implants different. The increasing amount of plaque on implant surfaces in this study obviously caused very little harm to the peri-implant tissues. The most reliable variable in evaluating the out- come of implants is probably the change in mar- ginal bone level. There was no significant change of the marginal bone level during the first year (Fig. 5). The mean value of the change was only 0.1 mm. This bone loss is very small compared with what has been found in connection with other implants (Adell et al. 1981) but of the same magni- tude as has been reported regarding Bonefit im- plants by Buser et al. (1991). At 155 of the 204 implants measured. the mar- ginal bone change ranged between +0.5 mm and =0.5 mm (Table 5). These implants may be con- sidered to have an unchanged bone level or at least a change of no clinical significance. At 20 implants a gain in bone level was recorded. The phenom- enon of bone gain has been demonstrated in other publications (Quirynen et al. 1992). Naert (1991) has suggested that the positive change in bone level may be a result of condensation of bone following physiological loading and that the denser bone is 341Astrand et al. Fig. 5. Intraoral Radiographs of patient with very small bone loss. After completion of the prosthetic treatment (A) and at the 1- year examination (B), interpreted as a gain of bone height. 29 implants had a loss of more than 0.5 mm with a greatest bone loss of 3.7 mm. If the bone level decreases down to the vents of the implant, an unfavourable situation is established and further bone loss may be expected. In one patient the bone level de- creased during the second year, and 4 of her im- plants had to be removed. The ITI Solid Screw might in this case have been a better choice. There is currently debate as to whether to use the non-submerged or submerged technique for in- stallation of oral implants. The submerged tech- nique is by far the most frequently used technique in Sweden. The aim of the investigation was ther fore to obtain increased knowledge of the use of non-submerged implants, As regards the sub- merged technique, it has been claimed that it is an advantage that the healing after the implant inser- tion can take place separated from the oral micro- biological environment and the possibilities of achieving osseointegration should be _ better. Should this hypothesis be true, a difference be- tween submerged and non-submerged inserted im- plants would probably affect the early healing period. In this study, uneventful healing around the non-submerged implants took place to about the same extent as has been reported with the sub- merged technique. These results seem to corrobo- rate experimental studies showing equal or better results of the non-submerged technique (Gotfreds- 342 enet al, 1990, 1991, Fiorellini et al. 1992, Weber et al. 1995) The survival rates of this study are of the same magnitude as in other studies regarding ITI-Bone- fit implants (Bernard et al. 1991, Buser et al. 1991, Behneke et al. 1992, Wedgwood et al. 1992, Donat” sky 1993, Mericske-Stern & Zarb 1993) and indi- cate possibilities of good long-term results. How- ever, final evaluation of an implant system must be based on several independent studies with long observation periods. Therefore, the intention is to follow these patients for a total period of 5 years before a final report is made. Résumé Des implants Bonefit non-enfouis ont été insérés dans les man ibules de 46 patients édentés. Ces patients ont ensuite regu soit lune prothése fixe soit une amovible puis ont été suivis durant une période de 2 années. Lors du premier examen annuel les superstructures ont été enfevées pour permettre de tester Ia sta- bilté implantaire individuelle. Des radiographies ont été elfec- tuées lors de la charge des implants. En tout 216 implants ont te placés. 4 implants ont été perdus avant la mise en charge et 4 durant la deuxiéme année de mise en fonction, e= quir repré- sente au taux de survie aprés un an de 98% et aprés 2 ans de 96%, La perte osseuse marginale moyenne durant Ia premiére année en fonetion était de 0.1 mm. Cependant les changements fosseux marginaux variaient énormément et quatre implants avaient subi une perte osseuse sévére. intention future est de Suivre ce groupe de patients avec des examens annuels sétalant sur une période de 5 années,Zusammenfassung In zahnlose Unterkiefer von 46 Patientsn wurden transmukise ITT Boneft Implantate (ITT Dental Impfant System) eingesetzt Die Patienten srurden mit einer festsitzenden Prothese oder ei: ner Hybridprothese versorgt und wahrend 2 Jahren nachunter- sucht, Bei der Einjahresuntersuchung wurden die Suprastruktu- ren entfernt, um die Stabiltit jedes einzelnen Implantates 2u tesien, Radiologische Untersuchungen wurden bei Erstbela stung der Implantate und nach einem Jahr durchgefubhrt. Es ‘wurden insgesamt 210 Implantate eingesetz. Vier davon gingen vor der Belastung und vier wihrend dem 2weiten Jahr verloren Dies ergab eine Uberlebensrate von 98% nach | Jahr und 96" nach 2 Jahren, Der mittlere marginale Knochenverlust im er- slen jahr unter Belastung betrug 0,1 mm. Die Veranderung des ‘marginalen Knochenniveaus zeigte jedoch eine sehr stacke Va- rabilitit und vier Implantateerlitten einen massiven Knochen: verlust, Das Ziel is es nun. diese Patientengruppe wahrend 5 Jahren weiterzubetreuen und jfhrlich zu untersuchen. Resumen Se introdueron implantes ITI Bonefit (ITI Sistema Dental TImplantes) no sumergidos en las mandibulas inferiores edéndu- las de 46 pacientes. Los pacientes se proveyeron con una prote- sis Aja 0 una sobredentadura. y se siguieron durante un periode dde 2 atios. En el examen de | ado, las suprastructures se retira ron permitiendo probar la estabilidad individual de los implan- tes. Los exmenes radiograficos se realizaron en conexién con la carga de Ios implantes y en el examen de 1 ao, En total se introdujeron 216 implantes. cuatro implantes se perdieron antes de cargar y cuatro durante el segundo ato de funcion, que da tuna tasa de supervivencia despues de | aio del 98% y despues de 2 aflos del 96%, La signficar la pérdida marginal de hueso durante el primer ano de funcién de 0.1 mm, Sin embargo. los ‘cambios marginals de hueso tuvieron un alto grado de varia- ida y cuatro de los implantes mostraron una pérdida severa de bhueso. La intencion esti en seguir este grupo de pacientes con eximenes anuales durante 5 afos. References Adell, R., Eriksson, B., Lekholm, U., Bréinemark, P-T, & Jem TT (1990) A long-term follow-up study of osseointegrated im plants in the treatment of the totally edentulous jaws. Inter- ‘ational Journal of Oral & Maxillofacial Implants : 347-359, Adell, R.. Lekholm, U.. Rockler. B. & Brinemark, P-I. 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