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

NCT ID: NCT07250256

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-12-01

Brief Summary

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

Detailed Description

The process of natural healing starts with new bone formation taking place from initial islands of bone within the connective tissue occurring after a 4 to 8 weeks interval from extraction date. This is followed by the manifestation of a mature trabecular structure that can be noticed at 10 to 20 weeks after extraction accompanied with a reduction in osteoblast count. As a result of the extensive bone resorption post extraction, the prosthetically driven implant placement is compromised and in need of some ridge preservation techniques that have been widely studied to try and ensure less alveolar bone loss. The aim of this research is to study the S1-XB Xenograft containing hydrogel and to evaluate its effects on extraction socket healing in comparison to natural socket healing. 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.

Conditions

Socket Preservation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group

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

Group Type: PLACEBO_COMPARATOR

Control (Standard treatment)

Intervention Type: PROCEDURE

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

Study group

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

Group Type: ACTIVE_COMPARATOR

S1-XB

Intervention Type: DEVICE

Socket grafted with xenograft containing alginate hydrogel material

Interventions

S1-XB

Socket grafted with xenograft containing alginate hydrogel material

Intervention Type: DEVICE

Control (Standard treatment)

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Suez Canal university

Ismailia, , Egypt

Countries

Egypt

Other Identifiers

547-2022

Identifier Type: -

Identifier Source: org_study_id