Clinical Trials Directory

Trials / Completed

CompletedNCT04060784

Maxillary Anterior Immediate Tooth Replacement With and Without Socket-shield

Maxillary Anterior Immediate Tooth Replacement With and Without Socket-shield: a One Year Prospective Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
25 (actual)
Sponsor
Loma Linda University · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREImmediate implant placement and provisionalizationFailing tooth will be extracted and immediate placed endosseous implant

Timeline

Start date
2019-08-30
Primary completion
2023-03-29
Completion
2023-03-29
First posted
2019-08-19
Last updated
2024-11-20

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT04060784. Inclusion in this directory is not an endorsement.