Autobone and Bioactive Glass With Ridge Splitting
Condition: Horizontal Alveolar Ridge Deficiency
Study type: Interventional

Summary: 
      Objective: To compare the use of autogenous bone graft versus autogenous bone graft mixed
      with bioactive glass bone graft in the treatment of maxillary anterior horizontal bone
      defects by ridge splitting technique combined with simultaneous implant placement.

      Materials and methods: Twenty-two patients were divided randomly into two groups; control
      group and study group. In control group, bone expansion was performed and autogenous bone was
      used to augment the intercortical bone defect. In study group, bone expansion was performed
      and autogenous bone mixed with bioactive glass was used to augment the intercortical bone
      defect. In both groups, the implants were inserted simultaneously with ridge splitting. 6
      months after implant placement, the mean bone width and alveolar bone loss values were
      evaluated. Statistical analysis using paired Student's t- test to compare results within the
      same group of patients, whereas, independent samples t-test was used to compare variables
      between the two groups
    

Detailed description: 
      Participants' selection:

      22 patients, aged from 18 to 50 years, were selected in this prospective, randomized and
      blinded clinical trial from the Outpatient Clinic of the Department of Oral Medicine and
      Periodontology, Faculty of Dentistry, Kafrelsheikh University. Those subjects had inadequate
      bone volume for implant placement due to width insufficiency of maxillary anterior alveolar
      ridges. The research ethical committee of Faculty of Dentistry, Kafrelsheikh University
      approved the study (KD/06/21). Research procedures were explained to all patients, and they
      agreed to participate in the study and signed the appropriate informed consent form. The
      inclusion criteria implemented for patient selection were good general health at the time of
      surgery; at least 3months postextraction healing period; and horizontally compromised
      maxillary anterior alveolar ridges (at least 3mm bone width and 13mm bone height). The
      criteria of patients exclusion were vertical bone defect; thick labial cortex with less
      cancellous bone inside; obvious undercut on the labial/buccal side; uncontrolled periodontal
      conditions; history of radiotherapy in the head and neck region; uncontrolled diabetes
      mellitus or other systematic disorders; smokers; pregnancy; non-compliant patients; and
      allergic reaction to the used medications.

      Pre-surgical therapy and grouping Pre-surgical therapy consisted of a thorough full-mouth
      scaling and root planning. Patients were randomly assigned immediately before surgery into
      two groups (11 patients each) by computer-assessed randomization software (Random Allocation
      Software, Version 1.0). Control group received ridge splitting with simultaneous implant
      placement in combination with autogenous bone graft alone, while study group used (1:1)
      mixture of autogenous and bioactive glass bone grafts. Bone volume was assessed two weeks
      before operation using CBCT (Scanora 3D, Soredex Oy, Tuusula, Finland).

      Surgical procedure:

      Operations were performed under local anesthesia. Mid-crestal incision followed by full
      thickness flap reflection to expose surgical site. Mid crestal cut using piezo-surgery unit
      (Piezotome® Cube, ACTEON®, Acteon Group Ltd, Norwich, England). Then, the cut was extended
      deep to the length of implant. Then, ridge was expanded progressively using bone wedges
      (Microdent Implant System, Spain). Implant location was marked, with a buccal bony wall as
      uniformly thick (>1 mm) as possible to avoid bone fracture. The implant site was prepared and
      3.75*13 mm dental implant fixture (Humana Dental Implants & Accessories GmbH, Germany) was
      placed stably in between the two bony plates.

      Autogenous bone harvesting:

      Incision was made at mucogingival junction in the symphysis area followed by full thickness
      flap reflection, and then corticocancellous bone was harvested using a trephine drill.
      Finally the flap was sutured by interrupted and horizontal mattress suture by 3-0 black silk.

      In control group, harvested autogenous bone graft was used for augmentation of the gap
      between buccal and lingual plates. Study group received the same way of treatment except
      using (1:1) mixture of the harvested autogenous bone with bioactive glass bone graft
      (BonyGlass, Pharma-Excellence, Egypt). The wound was completely closed in a tension-free way.
      All surgeries were performed by the same operator.

      Postoperative care:

      Patients were prescribed amoxicillin-clavulanic acid 1g. every 12hours antibiotic (Augmentin
      1g, SmithKline Beecham Pharmaceuticals), and 0.12% chlorhexidine hydrochloride mouth wash
      twice daily (Hexitol, ADCO, Cairo, A.R.E). The sutures were removed 14days postoperatively.
      No removable denture was allowed to wear for 2weeks.

      6months postoperatively, clinical evaluation was recorded including implant survival,
      presence of infection, pain, tenderness or wound dehiscence. CBCT was taken at 6months
      postoperatively to evaluate ridge width and bone level. All clinical and radiographic
      measurements were recorded by one calibrated masked examiner.

      Study variables The primary outcome variable was linear changes in the marginal bone
      surrounding the implants and alveolar ridge width, taken from cross-sectional and
      longitudinal CBCT images. Bone heights and width were assessed preoperatively and after
      6months postoperatively using the CBCT images.

      Statistical analysis:

      Sample size calculation was undertaken via G power version 3.1 statistical software based on
      the following pre-established parameters: an alpha-type error of 0.05, a power test of 0.80,
      a total sample of 22 subjects (11 subjects for each group) appeared to be sufficient.

      The statistical analysis was performed using IBM SPSS version 20 software (IBM Corp., Armonk,
      NY, USA). Data were presented as the mean+stanstandard deviation. The paired Student's t-
      test was used to compare the obtained results within the same group of patients at 2
      different intervals. The independent samples t-test was used to compare variables between the
      two groups. In all tests, the result was considered statistically significant if the P-value
      was <0.05.
    

Intervention name(s): mixture of bioactive glass and autogenous bone graft; autogenous bone graft
Intervention type(s): Procedure; Procedure
Intervention description(s): bone expansion was performed and autogenous bone mixed with bioactive glass was used to augment the intercortical bone defect after ridge splitting and simultaneous dental implants; bone expansion was performed and autogenous bone alone was used to augment the intercortical bone defect after ridge splitting and simultaneous dental implants
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ridge split; dental implant; piezosurgery; bioactive glass; autogenous bone