This study plans to enroll no fewer than 48 adult patients who have non-restorable maxillary anterior teeth due to trauma or dental diseases and are candidates for immediate implant placement, meeting the inclusion and exclusion criteria.
This is a prospective, multicenter, parallel-group, evaluator-blinded randomized controlled trial.It aims to compare the Socket Shield Technique (SST) with conventional immediate implant placement (IIP) in the maxillary anterior aesthetic zone, evaluating labial bone plate thickness, implant survival/success rates, pink aesthetics, and patient satisfaction to assess their clinical efficacy and aesthetic outcomes. Eligible participants will provide informed consent and be randomly assigned to groups via center-stratified randomization. Primary endpoint: Changes in buccal bone plate thickness at the implant shoulder and at 2, 4, and 6 mm apically at 6 months after prosthetic restoration (T3). Secondary endpoints: Implant survival and success rates; changes in buccal bone volume; changes in soft tissue contour convexity; Pink Esthetic Score (PES); patient satisfaction; operative time, pain levels, and treatment-related parameters. Safety endpoints: Intraoperative and postoperative adverse events, including infection, bleeding, wound dehiscence, implant loosening, peri-implantitis, shield fragment displacement/exposure/dislodgement, need for reoperation, and other serious adverse events (SAEs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
During tooth extraction, a stable buccal root fragment (shield) is preserved. The specific procedures are as follows: Minimally invasively extract the crown of the affected tooth, preserving a buccal root fragment approximately 1-2 mm in thickness; Adjust the coronal aspect of the root fragment to approximately 2 mm apical to the gingival margin, ensuring a rounded and blunt coronal edge that is flush with the alveolar crest; Maintain the integrity of the buccal bone plate without any fractures;
Completely remove the root of the affected tooth and complete the procedure according to the conventional immediate implant placement protocol: Minimally invasively extract the affected tooth (complete root extraction); Place the implant within the extraction socket (biased toward the palatal side); Fill the jump gap with a low-resorption xenogeneic bone substitute material; Perform soft and hard tissue management according to the conventional immediate implant placement SOP.
Thickness of the labial bone plate
The changes in the thickness of the labial bone plate at the implant shoulder and 2, 4, and 6 mm below
Time frame: 6 months after the restoration (T3)
Implant retention and success rate
Time frame: 3, 6,12 ,24 and 36 months after the operaiton
Volume change of the labial bone plate
Time frame: 6 months after the crown restoration was completed
Change in the contour curvature of soft tissues
Time frame: 6 months after the crown restoration was completed
Pink Aesthetic Score (PES)
Time frame: 6 months after the crown restoration was completed
Patients' satisfaction degree
Time frame: On the day after the surgery, the day of crown restoration completion, and 6 months after the restoration was completed
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