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Injectable Alloplastic Bone Graft for Socket Preservation: Clinical, Radiographic, and Histological Evaluation

ConditionsTooth ExtractionSocket Preservation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-60
SponsorSuez Canal University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Injectable Alloplastic Bone

    Procedure/Surgery

    Ten extraction sockets will undergo socket preservation using injectable bone substitute biomaterial following atraumatic tooth extraction and socket curettage.

  • natural healing (no graft)

    Procedure/Surgery

    Ten extraction sockets will be left unfilled after atraumatic extraction to allow normal physiological healing.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: the experimental group (IBS group)Experimental treatment 1 intervention
Group B: control group (natural healing)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in buccolingual ridge width assessed by CBCT

Buccolingual ridge width will be measured radiographically using CBCT immediately post-extraction (baseline) and after 4 months

Time frame
Baseline and 4 months
2

Bone density assessed by CBCT

Bone density of the extraction socket will be evaluated radiographically using CBCT gray values immediately post-extraction (baseline) and after 4 months.

Time frame
Baseline and 4 months
3

Percentage of newly formed bone assessed histomorphometrically

The percentage of newly formed bone will be evaluated histomorphometrically using hematoxylin and eosin staining during implant placement.

Time frame
3 months
4

Percentage of residual graft material

Residual graft material percentage will be assessed histomorphometrically using hematoxylin and eosin staining during implant placement.

Time frame
3 months

Secondary outcomes

1

Mucosal healing

Clinical mucosal healing will be assessed by the presence or absence of infection, swelling, and adverse tissue reaction during follow-up visits.

Time frame
Up to 4 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suez Canal University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: