The aim of the present clinical trial was to test tolerability during 2 treatments with EMDOGAIN in a large number of patients. An open, controlled study design in 10 Swedish specialist clinics was chosen, with a test group of 107 patients treated with EMDOGAIN in connection with periodontal surgery at 2 surgical test sites per patient. The procedures were performed 2 to 6 weeks apart on one-rooted teeth with at least 4 mm deep intraosseous lesions. A control group of 33 patients underwent flap surgery without EMDOGAIN at 1 comparable site. In total, 214 test and 33 control surgeries were performed. Serum samples were obtained from test patients for analysis of total and specific antibody levels. 10 of the patients had samples taken before and after the first surgery, 56 other samples were taken after one treatment with EMDOGAIN, and 63 after 2 treatments. None of the samples, not even from allergy-prone patients after 2 treatments, indicated deviations from established baseline ranges. This indicates that the immunogenic potential of EMDOGAIN is extremely low when applied in conjunction with periodontal surgery. Comparison between the test and control groups demonstrated the same type and frequency of postsurgical experiences, i.e., reactions caused by the surgical procedure itself. Clinical probing and radiographic evaluation was performed at baseline and 8 months postsurgery. About half of the patients (44 test and 21 control) were also evaluated after 3 years. There was a significant difference between the test and control results at 8 months postsurgery, and this difference had increased further at the 3 year follow-up. The 2.5-3 mm increase in attachment and bone level after treatment with EMDOGAIN was of the same magnitude as seen in the studies with split-mouth design aiming for test of effectiveness of EMDOGAIN.
The morphology of supragingival and subgingival calculus on extracted teeth was studied with the scanning electron microscope. Oral, crevicular, and fracture surfaces were examined. Both subgingival and supragingival calculus had a heterogenous core covered by a soft, loose layer of microorganisms. On supragingival calculus this layer was dominated by filamentous microorganisms while subgingival calculus was covered by a mixture of cocci, rods and filaments. The supragingival covering of filaments was oriented with the filaments approximately perpendicular to and in direct contact with the underlying dense calculus. This arrangement was rarely seen subgingivally where there was no distinct pattern of orientation. Some of the specimens of sub- and supragingival calculus were treated with sodium-hypochlorite. These lost the soft covering, and channels the same size as the filamentous organisms were found penetrating into the calculus. They were oriented prependicular to the surface in supragingival calculus but had no specific direction in subgingival calculus. The appearance of the channels supports the concept that calcification starts between the microorganisms in both subgingival and supragingival calculus.
THE ULTRASTRUCTURE of nondecalcified supragingival and subgingival calculus was studied in mature deposits. To facilitate sectioning of the embedded material, a thin reinforcing film of plastic was painted on the block. A new film was applied for each section. Light microscopy showed that supragingival calculus was heterogeneous with islets of calcified material within the covering plaque and with noncalcified areas within the calculus. Under transmission electron microscopy supragingival calculus was heterogeneous, dominated by microorganisms, small needle-shaped crystals and large ribbon-like crystals. In the covering soft plaque small crystals were often scattered in the intermicrobial matrix. In the supragingival calculus itself noncalcified microorganisms were surrounded with densely packed small crystals. There were also rosettes and bundles of large crystals. Subgingival calculus was homogeneous in light microscopy. The covering plaque contained no calcified material and only calcified material was seen within the calculus itself. Transmission electron microscopy of subgingival calculus revealed crystals of small size only. Subgingivally very few noncalcified microorganisms were seen within the calculus. The bacterial cell wall seemed to be the structure that was last calcified, both supragingivally and subgingivally.
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