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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04321109
Other study ID # FDASU-RECD 071402
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2, 2016
Est. completion date March 21, 2018

Study information

Verified date September 2022
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Seven Patients who need implants to replace non-restorable teeth in the esthetic zone. Intervention Group (1): Seven extraction sockets that received the collagen matrix (Collagen cone) for alveolar ridge preservation. Comparison Group (2): Seven extraction sockets that were treated with mineralized cortico-cancellous bone allograft for alveolar ridge preservation. Outcome 1. Alveolar ridge preservation both in height and in width to improve implant success rate - The height of alveolar ridge was assessed clinically using a periodontal probe. - The width of the alveolar ridge was measured after three months after extraction using a caliper clamp. - Changes in the width and height of alveolar bone were evaluated in merged axial and sagittal views using the I-CAT superimposition system (CBCT). 2- Evaluation of newly formed bone quality was performed by histological examination and histomorphometric analysis. 3- Immuno-histochemical staining was done using polyclonal antibody to detect (BMP-2) marker of bone formation


Description:

The aim of the present study was to compare three months post-extraction augmented ridge using collagen matrix versus mineralized cortico-cancellous bone allograft. This comparison was done clinically, histologically, immunohisto-chemically and radiologically. • Clinical parameters included; vertical bone height and bone width that were recorded at baseline and at three months after extraction. Moreover, histomorphometric parameters included; area fraction of osteoid and mature bone three months after extraction by histomorphometric analysis. Immunohistochemical analysis using polyclonal antibody to detect BMP-2 marker of bone formation. Radiographic parameters included superimposition of baseline CBCT, three months after extraction and another one six months after loading with subsequent measurement of bone height, bone width and bone density. A core biopsy was taken three months after tooth extraction which has undergone histomorphometric and immunohistochemical analysis; implant placement was also done at the same time. In the present study, it was found that the mean bone height decreased with a higher percent in collagen matrix group than mineralized cortico-cancellous bone allograft group with a non significant difference between both groups. In addition, this study showed that the mean bone width decreased more in collagen matrix group than mineralized cortico-cancellous bone allograft group with a non significant difference between them. Moreover, in the present study, Histomorphometric analysis revealed new bone trabeculae formation with osteoblastic rimming, the surrounding fibrous tissue is cellular and remnants of the graft materials was detected , with no marked difference in the amount of newly formed bone between two groups . Regarding immunohistochemical analysis in both groups, the osteoblasts in the fibrous tissue and osteocytes in newly formed bone are showing nuclear staining, with increasing area of immunopositive cells in mineralized cortico-cancellous bone allograft group. Radiographically, CBCT superimposition revealed that a greater percent decrease in bone height was denoted in collagen matrix than mineralized cortico-cancellous bone allograft group with a significant difference between both groups after 3 and 6 months. Accordingly bone width showed a higher decrease in mineralized cortico-cancellous bone allograft group than Collagen matrix group with a non significant difference between both groups after 3 and 6 months. Finally, bone density showed a greater decrease in Collagen matrix group than mineralized cortico-cancellous bone allograft group with a non significant difference after 3 months but significant difference was found after 6 months between both groups.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date March 21, 2018
Est. primary completion date March 21, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: 1. Patients were medically free . 2. Two teeth indicated for extraction due to either severe decay, tooth fracture or failed endodontic treatment. Exclusion Criteria: 1. Patients with poor oral hygiene or not willing to perform oral hygiene measures. 2. Pregnant and breast-feeding females. 3. Smokers , Teeth with periodontal or periapical infections. 4. Patients with malocclusion. 5. All patients who had known contraindication to dental implant surgery (e.g: bleeding tendency, radiotherapy, taking bisphosphonate)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Allograft
Corticocancellous mineralized allograft
Collagen cone
Collagen matrix

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Yasmine Fouad

Outcome

Type Measure Description Time frame Safety issue
Primary clinical score Dimensional changes in alveolar ridge after alveolar ridge preservation both clinically and radiographically change from baseline at 12 weeks
Secondary BMP-2 Bone morphogenic protein -2 immunopositive cells in immunostained sections detected at 12 weeks
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