Socket Preservation, Tooth Extraction
Conditions
Keywords
Injectable Alloplastic Bone Graft, Socket Preservation, Bone Regeneration, Clinical Evaluation, Radiographic Evaluation, Histological Evaluation
Brief summary
This study will evaluate the clinical efficacy of injectable alloplastic bone grafts in terms of radiography and histology in order to preserve tooth sockets following extraction. Methodology: Twenty new extraction sockets from twenty surgically extracted non-restorable mandibular molar teeth will be used in this clinical investigation.
Detailed description
Using computer randomization (http://www.randomlists.com), the 20 extraction sockets will be split into two equal groups (n=10) at random. Ten sockets (the experimental group) will undergo socket preservation using injectable bone substitute biomaterial. To permit normal physiological healing, the remaining 10 sockets (control group) will left unfilled. Clinical examination will be carried out after 2 days, 1 week, 2 weeks, 1 month, and 4 months, while after 4 months, radiographic measurements of bone dimension changes were carried out, and the histological inspection will be carried out three months after the removal of the tooth.
Interventions
PROCEDUREInjectable Alloplastic Bone
Ten extraction sockets will undergo socket preservation using injectable bone substitute biomaterial following atraumatic tooth extraction and socket curettage.
PROCEDUREnatural healing (no graft)
Ten extraction sockets will be left unfilled after atraumatic extraction to allow normal physiological healing.
Sponsors
Suez Canal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patient aged between 40 and 60 years. * General good health. * Presence of a hopeless mandibular posterior tooth that requires extraction. * Volunteer subjects have to voluntarily sign an informed consent. * Patient Indicated for implant.
Exclusion criteria
* Patient with systemic disease affection bone metabolism. * Large periapical radiographic changes related to the tooth to be Extracted, in the form of abscess, granuloma, or cyst. * Teeth need trans-alveolar extraction. * Patients with contraindication to surgical treatment. * Patients suffering from a psychological disorder. * Patients with uncontrolled medical conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in buccolingual ridge width assessed by CBCT | Baseline and 4 months | Buccolingual ridge width will be measured radiographically using CBCT immediately post-extraction (baseline) and after 4 months |
| Bone density assessed by CBCT | Baseline and 4 months | Bone density of the extraction socket will be evaluated radiographically using CBCT gray values immediately post-extraction (baseline) and after 4 months. |
| Percentage of newly formed bone assessed histomorphometrically | 3 months | The percentage of newly formed bone will be evaluated histomorphometrically using hematoxylin and eosin staining during implant placement. |
| Percentage of residual graft material | 3 months | Residual graft material percentage will be assessed histomorphometrically using hematoxylin and eosin staining during implant placement. |
| Percentage of connective tissue | 3 months | Connective tissue percentage will be assessed histomorphometrically using hematoxylin and eosin staining during implant placement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mucosal healing | Up to 4 months | Clinical mucosal healing will be assessed by the presence or absence of infection, swelling, and adverse tissue reaction during follow-up visits. |
Contacts
CONTACTMoataz Selmi
STUDY_DIRECTORdr mohamed elsholkamy el sholkamy, Professor
Suez Canal University
PRINCIPAL_INVESTIGATORmoataz mohsen zaki, master
Suez Canal University
STUDY_DIRECTORDr merihan nabih elmansy
Suez Canal University
STUDY_DIRECTORdr ahmed abdelmohsen younis
Suez Canal University
Outcome results
None listed