Clinical Trials Directory

Trials / Completed

CompletedNCT07460648

Two Stage Modified Socket Shield: Grafted vs Nongrafted

"Spontaneous Bone Healing in Two Stage Modified Socket Shield Therapy" Can It Be a Dependable Approach for Delayed Implant Placement? A Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Mansoura University · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Not accepted

Summary

Modified socket shield therapy (SST) has been proposed to preserve the facial plate and peri implant tissues. Whether spontaneous healing after two stage modified SST provides outcomes comparable to grafted SST before delayed implant placement remains unclear.

Detailed description

There remains no consensus regarding management of the space adjacent to the retained shield-whether it should be filled with a biomaterial or left for spontaneous healing. Clinical observations suggest that healing may not always yield complete mineralized fill; instead, a soft tissue interface can develop along the internal aspect of the root fragment, potentially limiting bone formation within the defect. At present, it remains unclear whether placement of a bone substitute can reliably reduce or prevent this soft tissue ingrowth along the inner surface of the retained fragment, providing a rationale for controlled comparisons of grafted and nongrafted two stage SST protocols. Therefore, the present controlled clinical study was designed to compare SST with xenograft combined with MPM augmentation versus SST alone, followed by delayed implant placement after a 6 month healing period. The study evaluated soft tissue ingrowth as key healing outcomes, alongside histologic findings and implant related parameters, including implant stability, as well as the incidence and management of procedure related complications.

Conditions

Interventions

TypeNameDescription
PROCEDURESocket Shield TechniqueNo grafting material was placed, and the socket was closed with a figure-of-eight suture to stabilize the clot
PROCEDURESocket Shield TechniqueThe xenograft/MPM mixture was gently packed into the shield-associated space/socket without excessive compression, and the socket was sealed and stabilized using a figure-of-eight suture technique

Timeline

Start date
2025-01-01
Primary completion
2025-12-31
Completion
2026-01-31
First posted
2026-03-10
Last updated
2026-03-10

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07460648. Inclusion in this directory is not an endorsement.