Immediate implant placement and provisionalization
ProcedureFailing tooth will be extracted and immediate placed endosseous implant
Other names: Socket shield technique
NCT Number: NCT04060784
The purpose of this clinical controlled study is to compare anterior facial gingival level change between Immediate implant placement and provisionalization with bone graft and with socket shield technique.
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Notify Me21 year and older
All sexes
Interventional
Not applicable
Loma Linda University Health, Loma Linda, California, United States
Immediate implant placement and provisionalization, short for IIPP, is one of a very viable option for failing anterior teeth. It has been advocated with documented success for more than 20 years. Despite the decent results, the challenges remains on the altered of the facial implant tissue architecture. To avoid the facial contour change and the possible following esthetic problem, clinicians have tried several ways to preserve the contour, like bone grafting in the gap between the facial bone and implant, or enhance facial gingival tissue thickness through augmentation procedures.
The concept of retaining part of the root, or root shield in conjunction with IIPP was proposed around 8 to 9 years ago. So-called socket shield technique. It has claimed to have successfully preserve the facial contour. Animal studies and couple clinical studies have showed decent results.
The purpose of this clinical controlled study is to compare the facial gingival level change between IIPP with bone graft and with socket shield technique. There are two groups in this study, 13 patients each. Extrusion criteria including male under 21 years old, female under 23 years old, smoker, pregnant patient, history of head and neck radiation, soft tissue defect like inflammation, recession, active infection. On the control group, patient will received IIPP with bone graft; On the test group, IIPP and socket shield technique will be provided. All clinical examinations and data collections will be performed by one investorgator, who will do the measurement at presurgical appointment, Tps, the time of implant placement, Tm0, 6-months Tm6, and 12-months after implant placement Tm12. Data analysis will be blind. Intraexaminer reliability will be performed.
We are looking at 12 elements in this study. The main variable will be facial gingival level change. We will use Intraoral scanner and the 3D images obtained at different time point will be superimposed, to see if there is any significant change between two groups.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(control group)
Exclusion criteria
(test group)
Failing tooth will be extracted and immediate placed endosseous implant
Other names: Socket shield technique
Time frame: At baseline (pre-op) and at 12 months after surgery
The baseline measurement will be compared with digital superimposition of intraoral scanned images at 12 months post-op
Time frame: At baseline (pre-op) and 12 months after surgery
The baseline measurement will be compared with digital superimposition of intraoral scanned images at 12 months post-op
Loma Linda University
Other
Maxillary Anterior Immediate Tooth Replacement With and Without Socket-shield: a One Year Prospective Study
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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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