Clinical trial NCT01623739: Esthetic, Clinical and Radiographic Outcomes of Immediately Placed Implants (Type 1) and Early Placed Implants (Type 2)
Official title: Esthetic, Clinical and Radiographic Outcomes of Immediately Placed Implants (Type 1) and Early Placed Implants (Type 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Acquired Absence of Single Tooth
Keywords: Dental implants
Esthetic score
Immediate implants
Early placement
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Institut Straumann AG
First posted: 2012-06-20
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are asking subjects to take part in a research study of soft tissue (gums) and bone (jawbone) healing around dental implants following tooth extraction. The investigators want to compare how the gums and the bone changes shape with healing in two different scenarios:

1. When the implant is placed at the same time the tooth is extracted.
2. When the tooth is extracted and then left to heal for a period of 4 to 8 weeks before the implant is placed.

Previous studies have shown that both methods work and can give good results. In fact the two methods are used routinely as part of standard care but it is not known if the two procedures are equally good since they have never been compared in one same research study.

Detailed description: This controlled, randomized clinical trial (RCT) is designed to compare soft and hard tissue dimensional changes for two commonly used approaches for replacing a recently extracted tooth by means of a dental implant, i.e. immediate implant placement (Type 1) or early implant placement (Type 2). Additionally, this study will evaluate the association between the osseous anatomy and implant position with soft and hard tissue changes.

Extraction sites will include maxillary and mandibular anterior and premolar teeth having intact adjacent teeth. Implants placed for this study will be SLA surface, bone level design, Straumann BL RC (Bone Level Regular Cross-fit ) 4.1mm or BL NC (Bone Level Narrow Cross-fit ) 3.3mm diameter implants at 8, 10, 12 or 14mm in length.

Immediate implant placement (Type 1) resulting in a horizontal defect dimension (HDD) will receive bone grafting, using freeze dried bone allograft (FDBA)(Straumann Allograft GC®) and will be covered by a resorbable membrane (BioGide®).

For the implants randomized to type 2 implant placement, the extraction socket will be filled with a collagen plug and allowed to heal for 4 to 8 weeks before the implant will be placed. Simultaneous guided bone regeneration (GBR) will be performed using FDBA (Straumann Allograft GC®)and a resorbable collagen membrane (BioGide®). The type 2 implant placement procedure will follow the guidelines as described by Buser et al. (2008).

All implant placement will follow standard protocols utilizing tapping and placement according to the manufacturer's guidelines.

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 following immediate placement protocols utilizing Straumann Bone Level implants RC 4.1mm or Bone Level Implant NC 3.3 mm at 8, 10, 12 or 14 mm in length.
7. One or more teeth in either the maxilla or mandible anterior or premolar areas requiring extraction leading to a single-tooth gap requiring implant placement as determined by the patient's dental provider.
8. Following extraction, surgical site anatomy presents conditions allowing immediate implant placement.
9. Primary stability of implant consistent with standards of care is achieved at the time of placement.

Exclusion Criteria:

1. Patient reports 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 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 coumadin (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: 3 months after crown delivery
Secondary outcomes:
measure: PES/WES (Pink Esthetic Score, White Esthetic Score).
timeFrame: 3, 6, 12, 24, 36, 48, 60 months after crown delivery
measure: Probing Depth
timeFrame: 3, 6, 12, 24, 36, 48, 60 months after crown delivery
measure: Modified Plaque Index
timeFrame: 3, 6, 12, 24, 36, 48, 60 months after crown delivery
measure: Modified Bleeding Index
timeFrame: 3, 6, 12, 24, 36, 48, 60 months after crown delivery
measure: Radiographic Bone Level
timeFrame: Up to 5 years 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: