Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04814160 |
| Other study ID # |
RSBG2021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 17, 2020 |
| Est. completion date |
April 15, 2021 |
Study information
| Verified date |
May 2021 |
| Source |
Kafrelsheikh University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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.
