Three-Dimensional Radiographic Bone Fill Evaluation Using Octacalcium Phosphate-Coated Deproteinized Bovine Bone Material (Ti-Oss Bone Graft) and Demineralized Freeze-Dried Bone Allograft (DFDBA) in Three Walled Defects.
Rimi Najeeb*, Anamika Sharma and Amit WadhawanDepartment Of Periodontology, Swami Vivekanand Subharti University, India
Introduction: The aim of the present study was to evaluate and compare the amount of bone fill in three wall defects treated by open flap Debridement (OFD) with Octacalcium Phosphate Coated deproteinized bovine bone material (Ti-oss) and DFDBA bone graft in the regeneration of human intra bony defects using CBCT.
Materials and Methods: A total of 20 defects in systemically healthy subjects diagnosed with moderate to advanced Generalized Chronic Periodontitis (GCP) were treated with OFD with octacalcium phosphate-coated deproteinized bovine bone material (Ti-oss Group A) and demineralized freeze-dried bone allograft (DFDBA-Group B). Clinical and radiograph parameters were assessed preoperatively and at 3 months and 6 months postoperatively. Data thus obtained was subjected to statistical analysis.
Results: Significant improvement was seen in PPD and RAL from baseline to 6 months for both the groups. However, on the intergroup comparison, there were no statistically significant differences observed. The radiographic parameters also showed statistically significant improvement from baseline to 6 months for both the groups & significant improvement was seen in bone density at 6 months in (Ti-oss group A) but no significant difference was observed when compared between the test and control groups at all time points.
Conclusion: Within the limitation of the current study, it can be concluded that Ti-oss did not show any improvement in the clinical and radiographic parameters over DFDBA except in bone density in the treatment of intra bony defects.
Keywords: Ti-oss; Demineralized Freeze-Dried Allograft; Intra bony Defect; Periodontitis
Regeneration of lost structure has become the primary therapeutic goal in Periodontology over the past several decades . The objective of periodontal regenerative therapy is to reconstitute the bone, cementum, and periodontal ligament on a previously diseased root surface . Angular bone loss adjacent to roots results in areas that are difficult to access and maintenance of effective plaque control . Various materials such as autogenous grafts, allografts xenografts, and alloplasts have been aimed at the treatment of intra bony defects.
To achieve regeneration, a number of surgical procedures like open flap procedures (e.g. modified Widman flap) alone or with bone grafts such as autogenous bone, allografts like Demineralized Freeze-Dried Bone Allograft (DFDBA), Freeze-Dried Bone Allograft (FDBA), various bone substitutes and Guided Tissue Regeneration (GTR) are employed .
New Gold standard in Xenograft, Macro pore Octacalcium Phosphate Coated Deproteinized Bovine Bone (Ti-oss) developed by Dr. Kim Sung 0 in Korea, has both Osseo-conductive and Osseo-inductive properties. Ti-oss is made from 100% bovine cancellous bone substitute. The high osteoconductivity of graft bone materials promotes the new bone formation by helping them in the growth of osteogenic cells and microvessels. The innovative pulverizing technique allows multi-porous structure, maximizing blood vessels growth.
This study is an effort to research and explore the outcome of radiographic bone fill using octacalcium phosphate-coated deproteinized bovine bone material (ti-oss bone graft) & DFDBA in human intra bony three-wall defects clinically and radiographically using CBCT to measure changes in bone density in Gray values after 6 months post-treatment.
A clinical and radiographic study was carried out to assess the efficacy of Octacalcium Phosphate-Coated Deproteinized Bovine Bone Material (Ti-Oss bone graft group A) and Demineralized Freeze-Dried Bone Allograft (DFDBA) (Group B) in the treatment of human infra bony defects. Patients were selected from Out Patient Department (OPD) of Periodontology, Subharti Dental College and Hospital, Meerut, Uttar Pradesh.
A total of 20 defects in systemically healthy and compliant subjects diagnosed with moderate to advanced Generalized Chronic Periodontitis (GCP) aged between 20-55 years showing clinical and radiographic evidence of angular defects in relation to mandibular premolars and molars were selected for the study and randomly divided into 2 groups.
The patients selected were explained the treatment procedure and the associated risks and benefits and their written consent was obtained.
Group A: 10 Intra bony defects were subjected to OFD with octacalcium phosphate-coated deproteinized bovine bone material (Ti-oss) bone graft particle size = (0.2 mm to 1.0 mm).
Group B: 10 Infra bony defects were subjected to OFD with DFDBA (300 pm to 500 pm). The following recordings were made in the proforma (annexure) designed for the study:
Medical history, dental history, and personal history
Clinical examination of the dentition.
CBCT to assess the area of the defect and bone density at baseline & after 6 months.
All clinical parameters i.e. GI , PI , OHIS , PPD, and RAL were recorded preoperatively (baseline) and postoperatively at 3 months and 6 months.
In the present research, differences in the oral hygiene status from baseline to 3 months to 6 months, respectively, and from 3 months to 6 months were not statistically significant (Table 1). Similarly, inter-group comparison (Table 2) at all-time points was also not statistically significant This suggests that oral hygiene was maintained optimally well throughout the period of study.
On application of paired t-test for Ti-oss, the mean difference in PI at different time intervals from baseline to 3 months was statistically not significant (P=0.1506). The value of the decrease in the PI from 3 to 6 months as a mean difference was statistically non-significant (P=0.0584). However, the change in the PI from baseline to 6 months was statistically significant (2=0.0008). For DFDBA mean difference from baseline to 3 months (P=0.6086), 3 to 6 months (P=0.0540) was statistically non-significant, and from baseline to 6 months (2=0.0158) was statistically significant (Table 1). While the result was non-significant at the all-time intervals on the inter-group comparison (Table 2). This was achieved by the reinforcement of plaque control measures and oral hygiene maintenance instructions at various recall periods.
This research demonstrates a decrease in pocket probing depth from baseline to 3 months and 3 to 6 months and baseline to 6 months highly statistically significant (2=0.0000), for Ti-oss and (P=0.0032) respectively, for DFDBA which was found to be statistically significant (Table 1). However, the result was non-significant at all-time intervals on the inter-group comparison (Table 2).
Similar observations were seen for RAL which demonstrates a mean difference of baseline to 3 months and baseline to 6 months for Ti-oss (P=0.0002), (P=0.0000) and P=(0.0004), P=(0.0000) for DFDBA at baseline to 3 months and 6 months, respectively, which was statistically significant but the mean difference between 3 to 6 months was statistically non-significant for Ti-oss P=(0.0811) whereas for DFDBA significant at 3 to 6 months (Table 1). The inter-group comparison was also non-significant at all-time points (P>0.05) (Table 2).
The observation of the study shows a decrease in the area of the defect from baseline to 6 months, respectively, in both the groups and, was found to be statistically significant. Furthermore, the difference from baseline to 6 months was statistically significant in both the groups (Table I) but the inter-group comparison was statistically insignificant (Table 2) (P>0.05).
An increase in the radiographic bone density for Ti-oss at baseline to 6 months. The mean difference in the BDF of the defect from baseline to 6 months was calculated by applying paired t-test, which was highly statistically significant (P=0.0003). For DPDBA (24.0002). The scores were found not to be statistically significant at the end of 6 months between the test & control groups (P>0.05). whereas BDF & BDF% scores were found to be statistically significant at the end of 6 months between test & control groups (p<0.05).
Radiographic measurements Radiographic bone fill (1213F) (%) after 6 months was then calculated by using the formula by Eickholz et al.  Changes in bone density (Gray values) after the bone fill was recorded at 6 months compared to baseline. Four Standard Region of Interest (ROIs) were selected for each defect . A mean value of 3 points was taken.
Local anesthesia (2% lidocaine, epinephrine 1:100,000) was injected at the site of surgery. The crevicular incision was given in the sextant of the defect, and a mucoperiosteal flap was raised. The area was degranulated, curetted, and irrigation was done with diluted betadine solution (Figures la-lt). The defect was isolated, and the graft was moistened in the patient's own blood and placed in small increments in the defect, and condensed until the defect was filled. Before graft placement, suturing was performed (Figure 2a, 2b). A periodontal pack is placed over the sutures.
Postoperative instructions are given and medication that included analgesics (Ibuprofen 400 mg after every 8 h) and antibiotics (Amoxicillin 500 mg every 6 h) for 5 postoperative days were advised to the patient.
The clinical parameters were recorded at baseline (Figure la) postoperatively at 3 months (Figure 2c) and at 6 months (Figure 2d). The Radiographic parameters were recorded at baseline (Figures lb-le) and at 6 months (Figures 2e-2h) and oral hygiene instructions were reinforced at every visit.
The data regarding the clinical and radiographic parameters for both the treatment groups recorded at baseline, 3 months, and 6 months was tabulated and subjected to statistical analysis. The student's paired t-test was applied for intra-group analysis, and Student's unpaired t-test was applied for the inter-group analysis. P<0.05 indicated a significant difference between the group means at a 5% level of significance. The following conclusions were considered: 1. If the calculated value was more than the tabulated value, then P<0.05 which is a significant difference was observed 2. If the calculated value was less than the tabulated value, then P>0.05 which is no significant difference observed between groups at a 5% level of significance.
The current study demonstrated a mean difference of GI from baseline to 3 months as (Pr-0.0042). The decrease in the GI from baseline to 6 months was calculated as a mean difference of (P=0.2103). Also, the change in the GI from 3 months to 6 months was (P=0.0004) for Ti-oss and (P=0.0144) which is significant from baseline to 3 months, (P=0.1131), (P=0.4241) respectively for DFDBA which was statistically insignificant (Table 1). The inter-group comparison was also non-significant at all-time intervals (Table 2).
This research was a comparative evaluation of Ti-oss and DFDBA in the treatment of intra bony defects. Periodic oral prophylaxis was performed so as to avoid the formation of plaque, calculus deposits, and debris on the grafted site as they could hamper the final outcome.
Results are in slight contrast with the observations reported by Oreamuno et al.  who reported a significant reduction in the mean plaque score but the decrease was statistically insignificant from baseline to 6 months. However, in the present research, there was a slight change of 1.05 ± 0.70 in the mean plaque score from baseline to 6 months but this was also statistically insignificant.
BRG when used alone to treat infra bony defects showed an approximate bone fill of 60% to 65%. Although an improvement occurs, a residual defect usually exists. Rumelhart et al.  also reported a mean osseous repair of 59% with the use of DFDBA and 66% with FDBA. Quintero et al.  also reported a mean osseous regeneration for all defects as 2.4 mm, representing a 65% mean bone-fill of the original defect. The findings demonstrated that DFDBA has potential as an osseous grafting material in periodontal therapy. However, in the present research mean difference in bone density fill of 92.72 and radiographic bone density fill % of 11.81% (p=0.0001).
Richardson et al. [131 compared the bovine-derived xenograft (BDX) Bio-Oss to DFDBA. BDX group showed statistically significant improvement as compared to DFDBA (P<0.05). Osseous measurements at 6-month re-entry showed bone fill of 2.4 mm (46.8%) for the DFDBA group and 3.0 mm (55.8%) for the BDX group. Defect resolution was 59.4% for the DFD BA group and 77.6% for the BDX groups Combination ABM/P-15 grafts demonstrated significantly better mean defect fill of 2.8 t 1.2 mm (72.3%) vs. a mean defect fill of 2.0 ± 1.4 mm (51.4%) for defects treated with DFDBA and a mean defect fill of 1.5 ± 1.3 mm (40.3%) for defects treated with OFD (P<0.005) (14j. The results of the above studies 113,141 were comparable to the present research in which the use of graft showed a bone fill of 26.04 ± 12.86% in the control group and 22.98 ± 15.64% in the test group in a time span of 6 months as evaluated by using CBCT (P<0.05). Ti-oss show statistically significant improvement as compared to DFDBA (P<0.05).
To the best of our knowledge, this is the 1st study to report the use of octacalrium phosphate-coated deproteinized bovine bone material (Ti-oss) bone graft in the treatment of Ultra bony defects in humans. Hence, a direct comparison with other studies was not possible. While monitoring changes in clinical and radiographic parameters with other studies, (Ti-oss) showed a significant improvement in soft and hard tissue regeneration also radiographic Bone Density Fill % (BDF %) was 22.76% in test group A (Ti-oss) as compared to control group B (DFDBA) radiographic BDF % was 10.95%. The amount of defect fill in mm, percent defect fill, and bone density fill was significantly improved at 6 months as compared to baseline.
Both treatment modalities demonstrated a significant improvement in the probing depth, RA L, and radiographic area of the defect and bone density fill at 6 months post-surgery. Octacalcium phosphate-coated deproteinized bovine bone material (Ti-oss) bone graft showed superior results regarding radiographic bone fill and radiographic bone density fill % than DFDBA.
Why is this case new information? It is 1st research reporting the use of Octacalcium phosphate-coated deproteinized bovine bone material (Ti-oss) in the treatment of intra bony defect to evaluate radiographic bone density fill.
What are the keys to the successful management of this case? Proper surgical technique, aseptic conditions, postoperative care, and follow-up are the keys to the successful management of this case.
What are the primary limitations to success in this case? Histological analysis has not been performed.
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