Injectable Alloplastic Bone Graft for Socket Preservation: Clinical, Radiographic, and Histological Evaluation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Injectable Alloplastic Bone, natural healing (no graft).
- Who it may be relevant to
- Registry conditions: Tooth Extraction, Socket Preservation. Basic parameters: 40 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical, Radiographic, and Histological Evaluation of Injectable Alloplastic Bone Graft in Extraction Socket Preservation
Overview
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
- Procedure Injectable Alloplastic Bone
Ten extraction sockets will undergo socket preservation using injectable bone substitute biomaterial following atraumatic tooth extraction and socket curettage. - Procedure natural healing (no graft)
Ten extraction sockets will be left unfilled after atraumatic extraction to allow normal physiological healing.
Primary outcome measures
- Change in buccolingual ridge width assessed by CBCT [Time frame: Baseline and 4 months]
- Bone density assessed by CBCT [Time frame: Baseline and 4 months]
- Percentage of newly formed bone assessed histomorphometrically [Time frame: 3 months]
- Percentage of residual graft material [Time frame: 3 months]
- Percentage of connective tissue [Time frame: 3 months]
Secondary outcome measures (1)
- Mucosal healing [Time frame: Up to 4 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07595445 · Surgery-Bone-01