Evaluation of the Efficacy of a Novel Synthetic Bone Regeneration Material (Sil-Oss®) In the Treatment of Periodontal Intrabony Osseous Defects

Study design The study was designed as a split-mouth, double-blind, randomized controlled clinical trial. The purpose of this study is to evaluate the efficacy of a novel synthetic bone regeneration material (Siloss®) in the treatment of periodontal intrabony osseous defects. Ethical clearance has been obtained from the institutional ethical committee with participants signing an informed consent prior to the commencement of the study.

Sample Size calculation Sample size was calculated by considering this trial as a non-inferiority trial. A minimum sample size of 27 will be required when the minimum difference of mean bone fill levels before and after treatment is to be at least 1mm2 at p=0.05 with expected variance of 0.8 for having ß=0.1.

Source of data A total of 30 subjects were selected from the outpatient section of the Department of Periodontics. Systemically healthy chronic periodontitis subjects within the age group of 30-55 years having at least 2 periodontal pockets ≥5 mm with at least 1 pocket in each quadrant showing ra¬diographic evidence of vertical bone loss were included in the study. Patients who underwent periodontal therapy in the past 6 months and/or have used antibiotic drugs, antioxidants, and antibacterial mouthwash or medicated toothpastes within 6 months of baseline and smokers were excluded from the study. Assessment of suitability for bone graft was confirmed by transgingival probing to verify the presence of well-contained interdental bone defects in as many quadrants.

Randomization and Blinding Randomization and blinding included computerized generation of the allocation sequence in random permuted blocks (block randomization) and blinded disbursement of medication. Allocation was performed by assigning the block of sites to study groups according to the specified sequence. Based on the sequence, the first operator selected two sites for each of the following experimental sites; the test site, in which graft (Siloss®) was placed and the control site which was treated by Hydroxyapatite graft only. All the surgeries were performed by a designated operator for the sake of uniformity whereas the relevant readings were recorded by the first operator who was blinded to the nature of the site. The blind was not broken until this clinical trial was completely finished.

Standardization of PPD and CAL PPD and CAL were recorded at the baseline and at the end of 3, 6 and 9 months using a UNC-15 color-coded periodontal probe. An alginate impression was taken and custom acrylic stent limited to the occlusal 2/3rds of the clinical crown were used as fixed reference position (i.e. junction of vertical groove and lower border of the stent). A groove was prepared in the stent to standardize the probing angulation throughout the study period.