Case Selection and Treatment Protocol for Immediate Dental Implants in the Esthetic Zone (NCT02154581) | Clinical Trial Compass
CompletedNot Applicable
Case Selection and Treatment Protocol for Immediate Dental Implants in the Esthetic Zone
United States41 participantsStarted 2013-01
Plain-language summary
In this study a tooth that needs to be extracted will be replaced by an implant (artificial root) placed at the same appointment as the extraction. The investigators want to observe how the gums change shape with healing in two different scenarios:
1. If the soft tissue around your tooth is thin, following extraction and implant placement an extra soft tissue graft (taken from your palate) in the area in order to increase the thickness of your gums after healing.
2. If the soft tissue around your tooth is thick, the implant will be placed without a soft tissue graft.
Previous studies have shown that both methods work and can give good results. In fact the two methods are used routinely but they have never been compared objectively to one another in the same research study.
The main purpose of this study is to evaluate if there is any difference in terms of esthetic outcomes between these two treatment modalities after a crown has been placed on the implant.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The patient is 18 years or older.
✓. Ability to understand and provide informed consent before starting the study.
✓. Ability and willingness to comply with all study requirements.
✓. The patient, if of child-bearing potential, has a negative urine pregnancy test.
✓. Adequate oral hygiene to allow for implant therapy consistent with standards of care.
✓. Adequate bone volume to accommodate the planned endosseous dental implant placement according to immediate placement protocols utilizing Straumann Bone Level implants RC (Regular Crossfit) 4.1mm or Bone Level Implant NC (Narrow Crossfit) 3.3 mm at 8, 10,12 or 14mm in length.
✓. One tooth in the anterior maxilla (first pre-molar to first pre-molar) requiring extraction resulting in a single- tooth gap planned to be restored with a dental implant as determined by the patient's dental provider.
✓. The site to be treated is surrounded by two natural teeth.
Exclusion criteria
What they're measuring
1
Mid Facial Mucosal Level at Implant Site
Timeframe: Change from Baseline to 3 months
Trial details
NCT IDNCT02154581
SponsorThe University of Texas Health Science Center at San Antonio
. Patient reports tobacco use within the last five years. Tobacco use for this study is defined as a current smoking habit with moderate or heavy smoking (more than 10 cigarettes per day) or tobacco chewing use.
✕. History of alcoholism or drug abuse within the past 5 years.
✕. Severe wear with an etiology of bruxism or clenching habits.
✕. Patient has significant untreated periodontal disease (grade III or IV), caries, or clinical or radiographic signs of infection within two adjacent tooth positions of implant area.
✕. History of HIV infection, Hepatitis B or C.
✕. Patients with a history of systemic disease that precludes standard dental implant therapy or alters daily activities to a level consistent with ASA (American Society of Anesthesiologists) III classification (including cardiovascular, hepatic, renal, gastrointestinal, metabolic, neurologic, pulmonary, endocrine, autoimmune, or psychiatric disorders).
✕. Presence of local inflammation or mucosal diseases such as lichen planus.
✕. Patient history consistent with high risk for subacute bacterial endocarditis.