Case Selection and Treatment Protocol for Immediate Dental Implants in the Esthetic Zone: A Controlled Clinical Trial

The University of Texas Health Science Center at San Antonio1 site in 1 country41 target enrollmentJanuary 2013

ConditionsJaw, Edentulous, Partially Acquired Absence of Single Tooth

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Jaw, Edentulous, Partially
Sponsor: The University of Texas Health Science Center at San Antonio
Enrollment: 41
Locations: 1
Primary Endpoint: Mid Facial Mucosal Level at Implant Site
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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:

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.
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.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

April 28, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The University of Texas Health Science Center at San Antonio

Responsible Party

Sponsor

Eligibility Criteria

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.
•Except the site to be treated, none of the maxillary incisors, canines and first pre-molars display marginal soft tissue recession.
•Following extraction, intact extraction socket bony walls are present.

Exclusion Criteria

•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.
•Current hematological disorder or warfarin (or similar) therapy.
•Patient has a disease that affects bone metabolism, such as, but not limited to, osteoporosis, hyperthyroidism, hyperparathyroidism, congenital connective tissue disorders (e.g., osteogenesis imperfecta), or Paget's disease.

Outcomes

Primary Outcomes

Mid Facial Mucosal Level at Implant Site

Time Frame: Change from Baseline to 3 months

Baseline will be at the time of crown delivery. Thereafter, the mid facial mucosal level at implant site will be recorded at 3, 6, 12 months after crown delivery.

Secondary Outcomes

Modified Plaque Index(Up to 1 year after baseline)
PES/WES (Pink Esthetic Score, White Esthetic Score).(Approximately 1 year after baseline)
Probing Depth(Up to 1 year after baseline)
Radiographic Bone Level(Up to 1 year after baseline)
Modified Bleeding Index(Up to 1 year after baseline)