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

NCT07595445 | Not Yet Recruiting

• 1 other identifier: Surgery-Bone-01
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tooth Extraction; Socket Preservation

Keywords

Injectable Alloplastic Bone Graft; Socket Preservation; Bone Regeneration; Clinical Evaluation; Radiographic Evaluation; Histological Evaluation

Outcome Measures

Primary Outcomes (5)

• 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

  Baseline and 4 months

• 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.

  Baseline and 4 months

• 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.

  3 months

• Percentage of residual graft material

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

  3 months

• Percentage of connective tissue

  Connective tissue percentage will be assessed histomorphometrically using hematoxylin and eosin staining during implant placement.

  3 months

Secondary Outcomes (1)

• Mucosal healing

  Up to 4 months

Study Arms (2)

the experimental group (IBS group)

EXPERIMENTAL

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

Procedure: Injectable Alloplastic Bone

control group (natural healing)

ACTIVE COMPARATOR

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

Procedure: natural healing (no graft)

Interventions

Injectable Alloplastic Bone PROCEDURE

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

the experimental group (IBS group)

natural healing (no graft) PROCEDURE

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

control group (natural healing)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Officials

• dr mohamed elsholkamy el sholkamy, Professor

  Suez Canal University

  STUDY DIRECTOR

• moataz mohsen zaki, master

  Suez Canal University

  PRINCIPAL INVESTIGATOR

• Dr merihan nabih elmansy

  Suez Canal University

  STUDY DIRECTOR

• dr ahmed abdelmohsen younis

  Suez Canal University

  STUDY DIRECTOR

Central Study Contacts

Moataz Selmi

CONTACT

01006848382; moatazselmi93@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share