A Phase 3 interventional study of Dental Implant in Dental Caries, sponsored by Louisiana State University Health Sciences Center in New Orleans. Status unknown at 1 site in United States. Open to participants aged 21 Months to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-11-09.
Sponsored by Louisiana State University Health Sciences Center in New Orleans · Phase 3 and Interventional
The purpose of this study is to determine the difference in success when placing implants immediately into an extraction site compared to delaying the implant placement until the extraction site has healed. In addition, the level of bone around the implants will be compared to determine if one method leads to better results over time.
This revised application is a clinical trial designed to evaluate crestal bone level changes when implants are placed into extraction sites and immediately provisionalized. Extraction of maxillary incisor teeth is a common procedure as documented in our school clinics. Traditional treatment when a tooth is extracted includes a period of healing followed by placement of an implant. Our preliminary data indicates that the delayed approach results in labial bone loss with resultant horizontal deficiency in over 50% of cases, requiring hard and soft tissue grafting to achieve a functional result. Additional preliminary data indicates that grafting the extraction site and/or immediate implant placement and provisionalization results in a functional restoration, without the need for additional adjunctive grafting procedures. It is unclear how the crestal bone levels change during healing of the extraction site prior to implant placement, in contrast to immediate implant placement, with immediate provisionalization with a crown. We hypothesize that there will be differences in the crestal bone levels (primary endpoint), and differences in soft tissue levels and indices (secondary endpoints) between implants immediately temporized, placed either delayed or immediately after tooth extraction, with more bone loss in the immediate placement group (experimental) compared to the delayed placement group (control). The long-term goal is to determine if the crestal bone remodeling after tooth extraction or the apical position of the implant determines the final level of the crestal bone. Two groups of 45 patients will be evaluated. All subjects will have a single rooted maxillary tooth extracted. One group will have the socket grafted with mineralized bone and allowed four months prior to implant placement. The crestal bone in this group will have remodeled during the four months of healing prior to implant placement. The second group will have the implant placed immediately after tooth extraction, thus the crestal bone will remodel in the presence of the implant and the immediately placed temporary restoration, as a one-stage procedure. For both groups, the implants will be immediately temporized with a crown after implant placement. Standardized hard and soft tissue data will be collected pre-extraction as baseline, and then prospectively for at least two years in this trial, to compare the methods and contrast the effectiveness of the proposed immediate restoration therapy.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's planned enrollment of 90 is above the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Louisiana State University Health Sciences Center in New Orleans is the lead sponsor of 70 studies on the registry; 12 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dental Implant 4 month time frame
Crestal bone levels adjacent to the implants
Time frame: 4 months
Position of the papillary complex and facial gingival margin, and indicator of the inflammatory state of the perimplant tissues.
Time frame: 4 months
This study is status unknown, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.
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Louisiana State University Health Sciences Center in New Orleans