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OpenTrials
Completed

NCT Number: NCT07460648

Two Stage Modified Socket Shield: Grafted vs Nongrafted

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry - Mansoura University

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I (healthy)
  • With intact buccal periodontal tissues
  • No parafunctional habits
  • Good oral hygiene
  • Willingness to comply with the study protocol and follow up schedule

Exclusion criteria

  • Acute infection at the extraction site
  • Extensive buccal plate loss
  • Vertical root fracture on the buccal aspect
  • Fracture patterns extending below bone level
  • Internal or external resorption
  • Root caries compromising the shield
  • Excessive tooth mobility
  • Heavy smoking

Treatment and study plan

Socket Shield Technique

Procedure

No grafting material was placed, and the socket was closed with a figure-of-eight suture to stabilize the clot

Primary outcomes

  1. Soft tissue ingrowth dimension: depth

    Time frame: 6-month (at the time of implant placement)

    Soft tissue ingrowth dimensions; depth and width were measured using a calibrated periodontal probe with readings taken to the nearest millimeter and rounded up when the probe reading reached or exceeded the midpoint between millimeter markings. Depth (mm) was recorded from the most coronal aspect of the retained root fragment and measured apically until hard tissue was encountered.

  2. Soft tissue ingrowth dimension: width

    Time frame: 6-month (at the time of implant placement)

    Width (mm) was measured in a buccopalatal direction from the central aspect of the socket shield to the point where hard tissue was reached, representing the maximum diameter of the soft tissue ingrowth.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: SST

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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