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

Clinical, Radiographic, and Histological Evaluation of Injectable Alloplastic Bone Graft in Extraction Socket Preservation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Socket Preservation; Tooth Extraction
• Intervention / Treatment: Procedure: Injectable Alloplastic Bone; Procedure: natural healing (no graft)

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moataz Selmi; Phone Number: 01006848382; Email: moatazselmi93@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the experimental group (IBS group); Ten extraction sockets will undergo socket preservation using injectable bone substitute biomaterial following atraumatic tooth extraction and socket curettage.	Procedure: Injectable Alloplastic Bone; Ten extraction sockets will undergo socket preservation using injectable bone substitute biomaterial following atraumatic tooth extraction and socket curettage.
Active Comparator: control group (natural healing); Ten extraction sockets will be left unfilled after atraumatic extraction to allow normal physiological healing.	Procedure: natural healing (no graft); Ten extraction sockets will be left unfilled after atraumatic extraction to allow normal physiological healing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mucosal healing	Clinical mucosal healing will be assessed by the presence or absence of infection, swelling, and adverse tissue reaction during follow-up visits.	Up to 4 months

Collaborators and Investigators

• Sponsor: Suez Canal University
• Investigators: Study Director: dr mohamed elsholkamy el sholkamy, Professor, Suez Canal University; Principal Investigator: moataz mohsen zaki, master, Suez Canal University; Study Director: Dr merihan nabih elmansy, Suez Canal University; Study Director: dr ahmed abdelmohsen younis, Suez Canal University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Bone Regeneration; Clinical Evaluation; Socket Preservation; Injectable Alloplastic Bone Graft; Radiographic Evaluation; Histological Evaluation
• Other Study ID Numbers: Surgery-Bone-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No