Radiographic and Histomorphometric Evaluation of Xenograft as a Socket Preservation Material in Maxillary Posterior Teeth.

NCT07250256 | Completed DMC

• 1 other identifier: 547-2022
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Radiographic and Histomorphometric Evaluation of Xenograft as a Socket Preservation Material in Maxillary Posterior Teeth: A Randomized-Controlled Clinical Study

Conditions

Socket Preservation

Keywords

Socket; Healing; bone formation; histomorphometery

Outcome Measures

Primary Outcomes (2)

• Histomorphometric analysis

  Samples were first stained with hematoxylin and eosin (H\&E) to demonstrate the general tissue architecture, cellular distribution, and overall structural organization. Subsequently, sections were stained with Masson's Trichrome (MTC) to allow both qualitative and quantitative assessment of bone trabeculae and osteoid tissue. Osteopontin (OPN) immunohistochemistry was used to assess the percentage of OPN expression area within the surrounding connective tissue. The OPN poly-colonal antibody was purchased from Thermo Fisher Scientific, Catalog # PA1-72061. Images were captured at ×400 magnification using a SOPTOP EX20 microscope with HD camera. ImageJ software was used to quantify area% from five standardized fields per section at oral pathology laboratory, Faculty of Dentistry, Suez Canal University.

  16 weeks

• Radiographic evaluation

  Cone-beam computed tomography (CBCT) scans (Scanora 3D) were obtained immediately after extraction at baseline and postponed at 4 months postoperatively to evaluate the following parameters: bone density that was measured in Hounsfield units (HU) at the center of the socket, ridge height that was determined by vertical distance from the crestal bone to a fixed reference point and ridge width that was measured at 3 mm apical to the crest.

  16 weeks

Study Arms (2)

Study group

ACTIVE COMPARATOR

(8 cases): was treated by immediate socket preservation with S1-XB xenograft augmentation after extraction.

Device: S1-XB

Control group

PLACEBO COMPARATOR

(8 cases): was not exposed to any type of socket preservation after the extraction procedure.

Procedure: Control (Standard treatment)

Interventions

S1-XB DEVICE

Socket grafted with xenograft containing alginate hydrogel material

Study group

Control (Standard treatment) PROCEDURE

Atraumatic extraction and sockets were allowed to undergo normal healing without any graft materials

Control group

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: males with general good health. Non smokers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male patients aged between 21 and 40 years.
• General good health.
• Absence of any relevant systemic disease.
• Presence of a hopeless maxillary posterior tooth that requires extraction.
• Extraction site suitable for replacement by a dental implant.
• Cases have adequate bone width and length.
• Volunteer subjects must sign an informed consent.

You may not qualify if:

• Poor oral hygiene with no possibility of improvement.
• Smokers (more than 10 cigarettes per day).
• Chronic treatment with any medication known to affect oral status and bone turnover.
• Drug or alcohol abuse.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal university

Ismailia, Egypt

Location

Study Design

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

Model Details: This is an In-Vivo comparative randomized controlled study that will be conducted on patients of the outpatient clinic of Oral and Maxillofacial department Suez Canal University to evaluate the difference between using S1-XB bone graft as a socket preservation material and normal socket healing without adding any socket preservation materials.

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: November 26, 2025
• Study Start: August 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

EG (1)