Human Periodontal Osseous Defects Research Articles

Evaluation and Comparison of Osteoinductive and Osteoconductive Bone Replacement Implant Materials in Treatment of Human Periodontal Osseous Defects. (A Clinical Controlled Study)

Evaluation and Comparison of Osteoinductive and Osteoconductive Bone Replacement Implant Materials in Treatment of Human Periodontal Osseous Defects. (A Clinical Controlled Study)

Prospective, Randomized, Multi-Center Feasibility Trial of rhPDGF-BB versus Autologous Bone Graft in a Foot and Ankle Fusion Model

The increased morbidity and surgical time associated with harvesting autologous bone graft (ABG) have encouraged surgeons to develop synthetic orthobiologic alternatives. The recombinant form of platelet-derived growth factor (rhPDGF-BB), an angiogenic, mitogenic, and chemotactic cytokine, has been shown to significantly enhance bone formation in human periodontal osseous defects when combined with a tricalcium phosphate carrier (β-TCP). The purpose of this prospective, controlled, randomized, multi-center feasibility clinical trial was to compare the safety and efficacy of this biosynthetic bone graft substitute (Augment™ Bone Graft) to ABG during ankle and hindfoot fusion. Twenty adult subjects requiring ankle or hindfoot fusion from three U.S. centers were enrolled and randomized in a 2:1 ratio to receive Augment™ or ABG, respectively. Surgical approach and fixation techniques were standardized, and minimum followup was 9 months. The primary endpoint was radiographic osseous union, evaluated by a blinded independent radiologist. Secondary endpoints included assessment of clinical success, union rate by serial computed tomography (CT) examination, time to full weightbearing, AOFAS Ankle-Hindfoot Score (AOFAS), Foot Function Index (FFI), Short Form-12 (SF-12), and Visual Analog pain assessment Scale (Pain VAS). At 36 weeks, 77% (10/13) of the Augment™ and 50% (3/6) of the ABG patients were fused based on radiographic criteria. There were two nonunions in the Augment™ group (9%, 2/14). Healing rates based on 12 week CT scanning (50% osseous bridging) were 69% (9/13) in the Augment™ and 60% (3/5) in the ABG groups, respectively. All functional outcome measures (FFI, AOFAS, SF-12), as well as the VAS pain scores, improved in both groups over time. Surgical procedure times lasted an average 26 minutes longer for the ABG as compared to the Augment™ populations. There were no device related serious adverse events in this study. Based on the available data, the rate of radiographic union, time to full weightbearing, and outcomes scores between the Augment™ and ABG subjects appear comparable. Augment™ may represent a safe and efficacious treatment alternative to ABG during foot and ankle arthrodesis.

Clinical Evaluation of the Combination of Anorganic Bovine‐Derived Hydroxyapatite Matrix/Cell‐Binding Peptide (P‐15) in Particulate and Hydrogel Form as a Bone Replacement Graft Material in Human Periodontal Osseous Defects: 6‐Month Reentry Controlled Clinical Study

This prospective, randomized, controlled clinical trial study compared the clinical outcomes of the biomaterial anorganic bovine-derived hydroxyapatite matrix/cell-binding peptide (ABM/P-15) as a biocompatible hydrogel carrier consisting of carboxymethylcellulose and glycerol or in particulate form when used as a bone replacement graft in the treatment of human periodontal infrabony defects. Nineteen patients with advanced chronic periodontitis were recruited. All patients had at least two non-adjacent intrabony osseous defects > or = 3 mm after completion of cause-related periodontal therapy. The surgical procedures included access flaps for root instrumentation and filling the defect with ABM/P-15 in hydrogel or particulate form. Reentry access flap surgery was performed at 6 months. Changes in soft and hard tissue outcome measurements between baseline and 6 months were evaluated in all defects. At 6 months, no significant differences between ABM/P-15 hydrogel and ABM/P-15 particulate were demonstrated for the amount of defect fill (3.10 +/- 0.85 mm [75.0%] versus 3.09 +/- 1.11 mm [73.7%], respectively) or defect resolution (85.8% versus 81.9%). Changes in soft tissue clinical outcomes did not show significant differences between the treatments. This trial failed to demonstrate superiority of the novel ABM/P-15 hydrogel therapeutic modality over the standard ABM/ P-15 particulate graft in the treatment of intrabony periodontal defects.

A 5-year follow-up of 16 patients treated with coralline calcium carbonate (BIOCORAL) bone replacement grafts in infrabony defects.

A resorbable coralline calcium carbonate graft material (BIOCORAL) (CalCarb) was evaluated as a bone replacement graft in human periodontal osseous defects. Following initial preparation and re-evaluation, flap surgery was carried out. Bone defects were curetted and root surfaces subjected to mechanical debridement and conditioning with tetracycline paste. The bone defects were grafted with CalCarb, and the host flaps replaced or slightly coronally positioned. Weekly, then monthly deplaquing was performed until surgical reentry at 6-12 months. Patients were then followed on approximate 3 month recalls for > or =5 years. Significant clinical changes included improvement in mean vertical clinical probing attachment level from 5.7 mm at surgery to 4.2 mm at re-entry to 4.0 mm at 5 years, decrease in mean probing pocket depth from 6.1 mm at surgery to 3.0 mm at re-entry to 3.3 mm at 5 years, and mean gingival recession from +0.4 mm at surgery to 1.0 mm at re-entry to 0.7 mm at 5 years (all at least p<0.05 from surgery to re-entry and surgery to 5 years, N.S. from reentry to 5 years via ANOVA). These favorable long-term results with CalCarb suggest that CalCarb may have a beneficial effect in the long-term clinical management of infrabony defects.

Comparison of Decalcified Freeze–Dried Bone Allograft and Porous Particulate Hydroxyapatite in Human Periodontal Osseous Defects

The purpose of this study was to clinically compare the healing potential of the osteoinductive decalcified freeze-dried bone allograft (DFDBA) with an osteoconductive synthetic graft, particulate porous hydroxyapatite (HA). Six patients ranging in age from 28 to 52 (mean age 42.6) participated in this investigation. They were without significant systemic disorders and had advanced periodontitis with at least two comparable periodontal defects. Each patient received initial therapy consisting of oral hygiene instruction, scaling, root planing, and occlusal adjustment as indicated. Probing pocket depth, gingival recession, attachment levels, and bleeding on probing were recorded in the posthygiene phase of therapy. Alveolar crest height and depth of osseous defect were obtained at the time of surgery. The cemento-enamel junction was used as the fixed reference point. All measurements were repeated at the time of a 6-month reentry. There was no significant difference in any of the soft tissue measurements when DFDBA and HA were compared. However, both treatment modalities reduced pocket depth and demonstrated a gain in clinical attachment levels. There was 2.2 mm of bone repair with DFDBA and 2.1 mm with HA. These values corresponded to a percent defect fill of 61% for DFDBA and 53% for HA. These values were likewise not statistically different.

Antigenicity of Freeze‐Dried Cortical Bone Allograft in Human Periodontal Osseous Defects

The purpose of this investigation was to determine whether donor-specific anti-HLA antibodies could be detected against freeze-dried cortical bone allograft (FDBA) placed in human periodontal osseous defects. Twenty patients with multiple periodontal bony defects amenable to treatment in two allografting procedures were enrolled. No patient had pre-existing anti-HLA antibodies. FDBA used for all allografting procedures was obtained from one donor of known HLA antigens, and all patients were tissue-typed. Serum samples were taken two weeks after the first allograft (primary challenge), two weeks after the second allograft (secondary challenge) and at three months. Serum samples were assayed for the presence of anti-HLA antibodies using an Amos modified microcytotoxicity assay. At no time could any donor-specific anti-HLA antibodies be detected in any patient. All allografts were judged clinically successful, with no adverse tissue reactions to the donor material. FDBA may be regarded as a graft material lacking clinically significant antigenicity.

Hydroxylapatite as an alloplastic graft in the treatment of human periodontal osseous defects.

Twelve patients, 32 to 60 years of age, received a polycrystalline ceramic form of pure dense hydroxylapatite as an alloplastic bone implant material in intrabony defects following reflection of full mucoperiosteal flaps, root planing and defect-curettement. The defects were measured from an acrylic stent, using an endodontic silver point which was placed to the base of the defect. Similarly, debrided and curetted defects in the same patients were not implanted and served as controls. Recalls for documentation and plaque control were at 1, 2, and 4 weeks, and at 3, 6 and 9 months. Measurements relating to changes in defect-depth were made upon reentry at 9 months. The twelve defects, serving as controls, showed very little difference between the pretherapy and 9-month measurements. The initial mean measurement from the base of the defect to the highest alveolar crest was 4.27 mm and the 9-month mean measurement after curettage only was 3.36 mm. In terms of resolution of the original defect this amounted to 19.49% reduction, but a 0.46-mm mean loss in height of the alveolar crest provided an actual percentage fill of the original defect of 9.91%. Of sixteen experimental defects, the same initial mean measurement from the base of the defect to the highest alveolar crest was 5.18 mm and the 9-month mean measurement after grafting was 2.43 mm. In terms of resolution of the original defect, this amounted to a 53.57% reduction, but in contradistinction to the curettage sites, a mean increase in height of the highest alveolar crest of 0.61 mm gave a true percentage fill of the original defect of 66.89%. At the 9-month reentry, the implanted mass seemed to be partially "calcified" and was resistant to penetration with a probe or removal with a curette. The data and clinical impression strongly suggest that hydroxylapatite has a potential as an alloplastic implant with clinically apparent acceptance by the soft and hard tissues.

Alloplastic implants of tricalcium phosphate ceramic in human periodontal osseous defects.

Initial pilot studies using tricalcium phosphate ceramic placed into human periodontal osseous defects demonstrated osseous repair. Therefore, further evaluation of this material was undertaken on 17 carefully selected patients with 1-wall, 2-wall, crestal and furcation defects using standardized preoperative and postoperative radiographs, clinical measurements and clinical photographs. Inverse bevel, full-thickness flaps were raised, the areas debrided, root surfaces planed with ultrasonic and hand instrumentation, osseous penetrations made with curet point and the flaps sutured after the defects were filled. Eighteen-month reentry surgical procedures were performed on 10 of the 17 patients, with a resultant average of 2.8 mm of new bone. Controls were not used in this study since a protocol describing a sham procedure with other than 3-wall osseous defects was not acceptable in 1973 to the Clinical Human Use Committee. Although the tricalcium phosphate ceramic material was not found to be totally predictable in this study, it may nevertheless become a useful graft material because of its potential for osseous repair in combination with its availability, host acceptability, ease of manipulation and storage advantages.

A six-month clinical evaluation of decalcified freeze-dried bone allografts in periodontal osseous defects.

The osteogenic potential of decalcified freeze-dried bone allografts in the treatment of human periodontal osseous defects was evaluated over a 6 month period. Cortical bone, obtained under sterile conditions from a human donor within 24 hours after death, was decalcified, freeze-dried and ground to a particle size of 250 to 500 microns. Twenty-seven osseous defects with one-, two- and wide three-wall morphology were treated. Clinical measurements were made with a stent and a calibrated periodontal probe before surgery, at the time of surgery, and at re-entry. The combined mean osseous regeneration for all defects was 2.4 mm. This represented a 65% mean bone-fill of the original defect. The findings demonstrate that decalcified freeze-dried bone allograft has potential as an osseous grafting material in periodontal therapy.