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Clin Oral InvestDOI 10.1007/s00784-005-0024-1 Stefan-Ioan Stratul . Frank Schwarz . Jürgen Becker .
Britta Willershausen . Anton Sculean Healing of intrabony defects following treatment with an oilycalcium hydroxide suspension (Osteoinductal). A controlledclinical study Received: 21 July 2005 / Accepted: 25 November 2005 Abstract The purpose of the present clinical study was to CAL gains (P<0.05) than AFS alone. Within the limits of evaluate the healing of deep intrabony defects following the present study, it can be concluded that: (1) at 6 months the application of an oily calcium hydroxide suspension after surgery both therapies resulted in statistically signif- (OCHS). Thirty patients suffering from chronic periodon- icant PD reductions and CAL gains and (2) treatment with titis, each of whom displayed one intrabony defect, were OCHS resulted in statistically significant higher CAL gains randomly treated with access flap surgery (AFS) and the application of OCHS (test) or with AFS alone (control).
The following clinical parameters were recorded at base- Keywords Regenerative periodontal therapy . Intrabony line and at 6 months after therapy: plaque index, gingival defect . Controlled clinical study . Oily calcium hydroxide index, bleeding on probing, probing depth (PD), gingival recession, and clinical attachment level (CAL). No differ-ences in any of the investigated parameters were observedat baseline between the two groups. At 6 months after therapy, the test group showed a reduction in mean PDfrom 7.7±1.5 to 2.9±0.9 mm (P<0.001) and a change in A major goal of periodontal treatment is to resolve inflam- mean CAL from 9.6±2.1 to 5.5±2.5 mm (P<0.001). In the mation and thereby arrest disease progression ]. The control group, the mean PD was reduced from 6.9±0.9 to results from controlled clinical studies have shown that 3.7±0.9 mm (P<0.001) and the mean CAL changed from nonsurgical treatment and various types of conventional 8.5±2.5 to 6.4±2.7 mm (P<0.001). OCHS resulted in sta- surgical treatment may lead to clinically important and tistically significant higher PD reductions (P<0.01) and statistically significant probing pocket depth reductions andclinical attachment level (CAL) gains , ]. However,histologic studies demonstrated that healing following S.-I. StratulDepartment of Periodontology, nonsurgical periodontal therapy and any type of conven- tional surgical periodontal therapy is mainly characterized by the formation of a long junctional epithelium along theinstrumented root surfaces and no predictable regeneration of attachment apparatuses [, ]. Ideally, peri- Department of Oral Surgery,Heinrich Heine University, odontal therapy does not only include arresting the disease but also the regeneration of the tissues that have been lostdue to the disease. This includes de novo formation of connective tissue attachment, cementum formation, and the Department of Conservative Dentistry and Periodontology,Johannes-Gutenberg University, regrowth of alveolar bone []. Several treatment modalities, such as the use of guided tissue regeneration (GTR) alone orin combination with different types of bone grafts, root surface demineralization, enamel matrix derivatives (EMDs), Department of Periodontology,Radboud University Medical Center, or the application of growth factors, have been employed with varying degrees of success to predictably accomplish 6500 Nijmegen, Philips van Leydenlaan 25, calcium hydroxide suspension (OCHS) has also been supposed to support periodontal regeneration [. Calcium hydroxide (CH) is a product of lime slaking from quick lime.
The slurry of CH incorporates carbon dioxide from the air program, and (4) presence of one intrabony defect with a and hardens with the formation of calcium carbonate and probing depth (PD) of >6 mm and an intrabony component water. CH is not soluble in organic acids, has a marginal of >3 mm as detected on radiographs. All patients solubility in water and an improved solubility in glycerine or underwent initial periodontal therapy 1 month prior to syrup. The saturated aqueous solution exhibits an alkalic pH surgery. The following clinical parameters were assessed value of 12.4. Several experimental studies have shown that 1 week prior to and 6 months after the surgical procedure CH may possess antimicrobial , and anti-inflamma- using a periodontal probe (PCP 12, Hu-Friedy, Chicago, tory properties []. When applied on amputated dental pulp IL, USA): PI gingival index (GI) bleeding on or into the root canal close to the apex, CH has been reported probing (BOP), PD, gingival recession (GR), and CAL.
to result in a destruction of the vital tissue, leading to the The measurements were made at six aspects per tooth: formation of a necrotic layer and, subsequently, formation of mesiovestibular, midvestibular, distovestibular, mesiolin- a hard tissue barrier below the exposure site , ].
gual, midlingual, and distolingual. The cemento–enamel Additionally, CH also seems to have a positive influence on junction (CEJ) was used as the reference point. A resto- the healing of periapical lesions , ]. These effects may ration margin was used as a reference in cases where the be mainly due to the alcalic properties of CH leading to a CEJ was destroyed due to restorations. All measurements neutralization of the acidic metabolites of macrophages and were performed by one previously calibrated examiner osteoclasts ]. However, the CH mechanism used to who was masked to the specific treatment procedures. The promote the repair of bone tissues may not only do so by study reports only measurements at the same deepest PD of providing rich Ca2+ and alkaline environment mineral the selected defect. Pre- and postoperative radiographs deposition, but also by stimulating the calcification enzyme were taken using the long-cone parallel technique. After activity of osteoblasts [The oily formulation, available controlling for the depth of the intrabony component and under the name Osteoinductal (Osteoinductal GmbH, CAL, all patients were randomly assigned to the following München, Germany) (OCHS), contains CH, liquid and treatment groups: (1) AFS and the application of an OCHS solid carbohydrate chains, and fatty acids (myristaleinic, (Osteoinductal, Osteoinductal GmbH, München, Ger- oleic, palmitoleinic, gadoleinic, margaric, pentadecanic, many) (test) and (2) AFS alone (control).
myristic, linolenic, stearic, palmitic, arachidic, lauric, andlinolic) esterified with glycerol. The oily parts consist of anatural product of porcine origin-oleum pedum, which was demonstrated to have a low cytotoxic effect on humanfibroblasts ], and vaselinum album. So far, there are no All operative procedures were performed under local data from controlled clinical studies evaluating healing of anesthesia by the same surgeon. Following intracrevicular intrabony defects following treatment with OCHS. There- incisions, full thickness mucoperiosteal flaps were raised fore, the aim of this controlled clinical study was to evaluate vestibularly and orally. Vertical releasing incisions were and compare the healing of advanced intrabony periodontal performed only if necessary for better access or to achieve defects following treatment with access flap surgery (AFS) better closure of the surgical site. All granulation tissue was and the application of OCHS and AFS alone.
removed from the defects and the roots were thoroughlyscaled and planed using hand and ultrasound instruments.
No root surface conditioning was performed. During surgery the following measurements were made: distancefrom the CEJ to the bottom of the defect (CEJ-BD) and distance from the CEJ to the most coronal extension of thealveolar bone crest (CEJ-BC). The intrabony component Thirty patients with chronic periodontitis were included in (INTRA, BC-BD) of the defects was defined as CEJ-BD this parallel-design study (i.e., 15 patients in each group).
minus CEJ-BC. At the test sites, bleeding into the defects The patient population comprised 20 men and 10 women was reduced to a minimum and the sites were subsequently (mean age=43±15 years). Patients who reported to smoke filled with OCHS, starting from the bottom of the defect.
only occasionally were not considered as smokers Care was taken to obtain direct contact between OCHS and According to the given definition there were no smokers the adjacent alveolar bone without interposition of a blood included in the present study. The study was in accordance clot. Defects were slightly overfilled, as the OCHS has a with the Helsinki Declaration of 1975, as revised in 1983 creamy consistency and tends to leak from the defect.
and all participants signed informed consent forms. The Finally, the mucoperiosteal flaps were repositioned cor- study protocol was approved by the Ethical Committee of onally and fixed with vertical or horizontal mattress the Victor Babes University of Medicine and Pharmacy of sutures. Where possible, sutures were put in position Timisoara, Romania. Criteria needed for inclusion were: before filling the defects with the OCHS to prevent the (1) no systemic diseases that could influence the outcome possible leakage of the material. The same surgical of the therapy, (2) a good level of oral hygiene [plaque protocol was also used for the control sites; however, the index (PI) <1] (3) compliance with the maintenance Table 1 Configuration and distribution of the treated defects Table 4 Clinical parameters at baseline and 6 months after surgeryfor the test and control groups (n=15 patients in each group) Table 2 Baseline defect characteristics (mean±SD) All patients received peri- and postoperative antibiotic power (1-β) of 0.75 was computed for a two-sided null medication for 1 week (3× 500 mg amoxicillin/day). Addi- tionally, postoperative care consisted of rinsing with 0.2%chlorhexidine (PlakOut, Santa Balanos, Greece) twice a dayfor 4 weeks. The sutures were removed 14 days after the surgery. Recall appointments were scheduled every secondweek during the first 2 months after surgery and monthly At the baseline examination, there were no statistically following the rest of the observation period. Neither significant differences in any of the investigated param- probing nor subgingival instrumentation was performed eters. The configuration of the defects is shown in Table during the first 6 months after the surgery.
The depth of the intrabony component as measured duringsurgery is presented in Table The postoperative healingwas uneventful in both groups. No complications, such as allergic reactions, abscesses, or infections, were observedthroughout the study period. However, minor postoperative The statistical analysis was performed using a commer- swelling appeared to be reduced in the test group as cially available software program [Statistical Package for compared to the control group. The mean PI, GI, and BOP the Social Sciences (SPSS) 11.0, SPSS, Chicago, IL, for both groups at baseline and after 6 months are USA]. The primary outcome variable was CAL. In the summarized in Table . In both groups, mean PI values calculations, only the deepest PD per tooth was taken into remained low throughout the study period. There were no consideration. For the statistical evaluation of the changes statistically significant differences within or between from baseline to 6 months after surgery, the Wilcoxon groups. In both groups the GI and BOP improvement signed-rank test was used. For comparisons between the was statistically significant as compared to the baseline groups, the Mann–Whitney U test was used. For the given (P<0.01). However, at 6 months after surgery, the input values (CAL and SD of both groups, a level of difference between the groups was statistically not signif- significance of alpha=0.05, and a sample size of 15), a icant. The mean PD, GR, and CAL in both groups atbaseline and after 6 months are summarized in Table . In Table 3 Mean (±SD) PI, GI, and BOP at baseline and after6 months (n=15 patients in each group) Table 5 Frequency distribution of CAL gain in the test and controlgroups (n=15 patients in each group) particular, at 6 months after therapy, the test group showed gen) with 3.6±1.5 mm. In particular, CAL gains of 2–3 mm a reduction in mean PD from 7.7±1.5 to 2.9±0.9 mm were observed in 29.2% of the defects, while CAL gains of (P<0.001), and a change in mean CAL from 9.6±2.1 to 5.5± 4–5 mm were reported in 35.4% of the defects, and CAL 2.5 mm (P<0.001). In the control group, the mean PD was gains of 6 mm or more were reported in 24.9% of the defects reduced from 6.9±0.9 to 3.7±0.9 mm (P<0.001), and the mean CAL changed from 8.5±2.5 to 6.4±2.7 mm (P<0.001).
group might also be compared with previously published OCHS resulted in statistically significant higher PD clinical data on EMD. Hejil et al. reported CAL gains of reductions (P<0.01) and CAL gains (P<0.05) than AFS 2.1 mm 8 months postoperatively and 2.3 mm 16 months alone. The frequency distribution of CAL gains in both postoperatively (baseline CAL=9.4 mm, INTRA=4.8 mm).
treatment groups is shown in Table In particular, in the There was a statistically significant difference between test group, 66.6% of the sites (n=10 defects) gained at least EMD- and placebo-treated sites. Similarly, Pontoriero et al.
4 mm of CAL. In contrast, a CAL gain of 4 mm or more ] reported a mean CAL gain of 2.9 mm for EMD-treated was measured in four defects (26.7%) in the control group sites after 1 year, with a statistically significant difference CAL=9.1 mm, INTRA=4.2 mm); Froum et al. [] reporteda 4.26-mm CAL gain (baseline CAL was not reported, INTRA=5.63 mm); and Sculean et al. [reported a 3.4-mm CAL gain (baseline CAL=10.6, INTRA=3.8 mm). The The results of the present study have indicated that treatment mean CAL gain of 2.1±2.3 mm obtained in the control of intrabony defects with both OCHS and AFS resulted in group is also in agreement with most of the reported results statistically significant and clinically important reductions of ]. However, slight differences noted in these PD and gains of CAL at 6 months after surgery. However, data may be explained by baseline defect depths and the test treatment resulted in statistically significant higher configurations. Indeed, it is well documented that the PD reductions and CAL gains than the control treatment.
postoperative PD reduction and CAL gain obtained after any From a clinical point of view, it should also be noted that type of conventional or regenerative periodontal treatment is postoperative healing was uneventful in all patients. Because dependent upon the initial defect depth (i.e., the deeper the there were no signs of any allergic reactions, abscesses, or defect, the higher the CAL gain) [, , In this context, infections, it might be suggested that OCHS was well it must also be emphasized that even though mean initial PD, tolerated. Furthermore, the observation that postoperative CAL, and INTRA were statistically not significant between swelling tended to be lower in the OCHS-treated than in the both groups, mean values tended to be higher in the OCHS AFS-treated group might be explained by the anti-inflam- group. Accordingly, it is impossible to estimate to what matory properties noted for CH [However, one problem extent this difference might also have influenced the higher encountered during the surgical procedure was the low mean CAL gains following the application of OCHS.
consistency of OCHS which in turn might result in the Nevertheless, the present data seem to indicate that OCHS mucoperiosteal flap having poor resistance to collapsing into might be successfully used for treatment of intrabony the intrabony defect, allowing undesirable cell types to enter periodontal defects. In this context, however, it is important the secluded wound area [, Indeed, this flap to realize that the presented clinical results need to be collapse may have implications on the outcome of treatment supported by extended histologic evidence. It is still unclear in a manner similar to that observed following the ap- to what extent the CAL gains obtained following application plication of enamel matrix proteins (EMD) In this of OCHS represent real periodontal regeneration rather than context, the collapse may be prevented by means of implan- defect fill without new connective tissue attachment. Also, tation of additional bone grafts or bone graft substitutes into the stability of the obtained CAL gains over time has to be the defect to support the OCHS in preserving its original evaluated in further clinical studies.
position. Further studies are necessary to clarify this issue.
Within the limits of the present study, it can be concluded When interpreting the present results, it has to be noted that that: (1) at 6 months after surgery both therapies resulted in mean CAL gain as observed 6 months postoperatively was statistically significant PD reductions and CAL gains, and 3.9±1.2 mm in the OCHS group and 2.1±2.3 mm in the AFS (2) treatment with OCHS resulted in statistically significant group. In this context, it needs to be pointed out that these higher CAL gains than treatment with AFS alone.
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