Clinical trial NCT02154581: Case Selection and Treatment Protocol for Immediate Dental Implants in the Esthetic Zone
Official title: Case Selection and Treatment Protocol for Immediate Dental Implants in the Esthetic Zone: A Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Acquired Absence of Single Tooth
Keywords: Dental implants
Esthetic score
Immediate implants
Gingival biotype
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: ITI International Team for Implantology, Switzerland
First posted: 2014-06-03
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.


Eligibility criteria: 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 (Regular Crossfit) 4.1mm or Bone Level Implant NC (Narrow Crossfit) 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 (American Society of Anesthesiologists) 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.

Primary outcomes:
measure: Mid Facial Mucosal Level at Implant Site
timeFrame: Change from Baseline to 3 months
Secondary outcomes:
measure: PES/WES (Pink Esthetic Score, White Esthetic Score).
timeFrame: Approximately 1 year after baseline
measure: Probing Depth
timeFrame: Up to 1 year after baseline
measure: Modified Plaque Index
timeFrame: Up to 1 year after baseline
measure: Modified Bleeding Index
timeFrame: Up to 1 year after baseline
measure: Radiographic Bone Level
timeFrame: Up to 1 year after baseline
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Graduate Periodontics, Dental School, UTHSCSA
state: Texas
Study officials:
affiliation: UTHSCSA Department of Periodontics
name: Guy Huynh-Ba, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: