Novel Bone Substitute (ALBO-OS) in Patients With Periodontal Disease or Who Need Alveolar Preservation

• vital signs, and laboratory tests were monitored
• in case of an adverse event occurrence, the symptoms, onset date, resolution date, and the degree of severity will be recorded. The three levels of adverse events intensity are defined: mild, moderate, and severe.

Changes of the depth of periodontal pockets: Changes of the initial periodontal probing depth (PPD) ≥ 5 mm, caused by formation of the new bone tissue inside periodontal pockets, determined by CBCT, comparing their dimensions before implantation and 6 months after implantation of bone substitute, in mm.

Changes of the depth of periodontal pockets:

Changes from baseline clinical attachment level (CAL) measured by CBCT as a distance from the cementoenamel junction (CEJ) to the bottom of the periodontal pocket (PD) before implantation and 6 months after implantation of bone substitute, in mm.

Gingival index (GI) is a numerical index for determining the level of gingival inflammation. LoeSilness was used as a numerical index to determine the level of gingival inflammation following the Gingival Index criteria:

0: Normal gingiva

• Mild inflammation (slight color change and edema, but no bleeding on probing)
• Moderate inflammation (redness, edema, glazing, and bleeding on probing)
• Severe inflammation (marked redness and edema, ulceration, and tendency to spontaneous bleeding.

Plaque index (PI) is a numerical index for determining the level of oral hygiene. SilnessLoe prices are given as follows:

0 - No plaque

• - Plaque adhering to the gingival margin and adjacent area of the tooth. The plaque can be seen in situ only after application of a disclosing solution or by using the probe on the tooth surface.
• - Moderate accumulation of soft deposit within the gingival pockets, or the tooth and the gingival margin, which can be seen with the naked eye.
• - Abundance of soft matter within the gingival pockets (PI index was calculated by using formula: PI=Ʃ Scores for plaque/4 surfaces x number of teeth).

The Miller mobility index (MMI) is a numerical index for determining the mobility of the tooth. It assesses the horizontal and vertical movement of a tooth within its socket to determine periodontal health.

Grade 0: Physiological mobility, undetectable/normal (up to 0.2) Grade 1: Slight mobility (horizontal movement between (0.2-1mm) Grade 2: Moderate mobility (horizontal movement > 1mm) Grade 3: Severe mobility (horizontal movement >1 mm and vertical displacement (depressible)).

A horizontal reference line is defined tangential to the most apical point of the extraction socket, whereas a vertical reference line was marked perpendicular to it, passing through the central axis of the socket, respectively. Regarding alveolar ridge height two vertical dimensions will be evaluated along the vertical reference line. The vestibular (VH) and oral (OH) heights of alveolar ridge (in mm) are defined as the distances from the horizontal reference line to the most coronal points of the buccal and oral aspects of the bone cortical level (BCL), respectively.

For measurements of alveolar ridge width (in mm) three horizontal parameters are positioned perpendicular to the vertical reference line at three standardized levels apical to the crestal bone level:

HW-1: 1 mm apical to the crest; HW-3: 3 mm apical to the crest; HW-5: 5 mm apical to the crest

Bone samples harvested at the time of implant placement following alveolar ridge preservation will be evaluated and histologically described in detail. The hard tissue specimens will fixed in 4% buffered buffered formaldehyde, following by decalcification in formic acid idehydration with increasing concentrations of ethanol. The next step will be embedding the tissue in a supportive medium-paraffin wax. Serial longitudinal sections measuring 0.004 mm in thickness will be prepared by means of microtome. Finally, the sections will be stained in Hematoxylin and Eosin to make cell components visible and mounted for microscopic examination. The histological examination will be carried out using light microscopy (Leitz Labor Lux S fluorescent microscope, Ernst Leitz Wetzlar GMBH, Wetzlar, Germany). The morphometric evaluation was performed at 400× magnification using a digital camera system (Leica DFC295, Wetzlar, Germany).

Buccal bone plate thickness (BBP) in mm will be measured at standardized vertical levels apical to the crestal bone level, which is defined as the most coronal point of the alveolar ridge. Measurements will be performed perpendicular to the outer contour of the buccal cortical surface at the following levels:

BBP-1: 1 mm apical to the crest; BBP-3: 3 mm apical to the crest; BBP-5: 5 mm apical to the crest

(H(before preservation)-H(after preservation))/(H(before preservation)) x 100=% linear socket fill

The subgingival space will be gently probed with a periodontal probe from the distal to the mesial, both on the vestibular and the oral side. If bleeding occured about 10 seconds after probing it was recorded as a positive (+) value. If there is no bleeding, it was recorded as a negative value (-). All present, fully erupted teeth, except for the third molars will be evaluated. The index value will be expressed as a percentage. This will be done by dividing the number of tooth surfaces with bleeding, with the number of examined tooth surfaces, and multiply it by 100.