Case Selection and Treatment Protocol for Immediate Dental Implants in the Esthetic Zone

Inclusion Criteria:

1. The patient is 18 years or older.

2. Ability to understand and provide informed consent before starting the study.

3. Ability and willingness to comply with all study requirements.

4. The patient, if of child-bearing potential, has a negative urine pregnancy test.

5. Adequate oral hygiene to allow for implant therapy consistent with standards of care.

6. Adequate bone volume to accommodate the planned endosseous dental implant placement
according to immediate placement protocols utilizing Straumann Bone Level implants RC
4.1mm or Bone Level Implant NC 3.3 mm at 8, 10,12 or 14mm in length.

7. 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.

8. The site to be treated is surrounded by two natural teeth.

9. Except the site to be treated, none of the maxillary incisors, canines and first
pre-molars display marginal soft tissue recession.

10. Following extraction, intact extraction socket bony walls are present.

11. Primary stability of implant consistent with standards of care is achieved at the time
of implant placement.

12. Patient must be able to pay for fees related to the surgical implant placement related
to extraction, grafting of the implant site, and half of the cost of the crown at the
time of implant placement.

Exclusion Criteria:

1. 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.

2. History of alcoholism or drug abuse within the past 5 years.

3. Severe wear with an etiology of bruxism or clenching habits.

4. 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.

5. History of HIV infection, Hepatitis B or C.

6. Patients with a history of systemic disease that precludes standard dental implant
therapy or alters daily activities to a level consistent with ASA III classification
(including cardiovascular, hepatic, renal, gastrointestinal, metabolic, neurologic,
pulmonary, endocrine, autoimmune, or psychiatric disorders).

7. Presence of local inflammation or mucosal diseases such as lichen planus.

8. Patient history consistent with high risk for subacute bacterial endocarditis.

9. Current hematological disorder or warfarin (or similar) therapy.

10. 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.

11. Patient is taking medications or having treatments known to have an effect on bone
turnover, including: thiazide diuretics, calcitonin, systemic steroids,
bisphosphonates, vitamin D (>800 IU/day), estrogen or progesterone therapy.

12. Current steroid treatment: defined as any person who within the last two years has
received for two weeks a dose equivalent to 20 mg hydrocortisone.

13. Patient currently undergoing chemotherapy.

14. Patient history of radiation treatment to the head or neck.

15. Physical or mental handicaps that would interfere with patient's ability to exercise
good oral hygiene on a regular basis.

16. Use of any investigational drug or device within the 30 day period immediately prior
to implant surgery.

17. Patient is pregnant.

18. Extraction sites having anatomic conditions that preclude immediate implant placement.