Esthetic, Clinical and Radiographic Outcomes of Immediately Placed Implants (Type 1) and Early Placed Implants (Type 2)
This study is currently recruiting participants.
Verified January 2013 by The University of Texas Health Science Center at San Antonio
Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborator:
Institut Straumann AG
Information provided by (Responsible Party):
Guy Huynh-Ba, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01623739
First received: April 26, 2012
Last updated: January 30, 2013
Last verified: January 2013
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Purpose
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:
- When the implant is placed at the same time the tooth is extracted.
- 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.
| Condition | Intervention |
|---|---|
|
Jaw, Edentulous, Partially Acquired Absence of Single Tooth |
Procedure: Placement of a dental implant |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Esthetic, Clinical and Radiographic Outcomes of Immediately Placed Implants (Type 1) and Early Placed Implants (Type 2) |
Further study details as provided by The University of Texas Health Science Center at San Antonio:
Primary Outcome Measures:
- Mid facial mucosal level at implant site [ Time Frame: Up to 5 years after baseline ] [ Designated as safety issue: No ]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, 24, 36, 48, 60 months after crown delivery.
Secondary Outcome Measures:
- PES/WES (pink esthetic score, white esthetic score). [ Time Frame: Up to 5 years after baseline ] [ Designated as safety issue: No ]Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.
- Probing depth [ Time Frame: Up to 5 years after baseline ] [ Designated as safety issue: No ]Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.
- Modified plaque index [ Time Frame: Up to 5 years after baseline ] [ Designated as safety issue: No ]Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.
- Modified bleeding index [ Time Frame: Up to 5 years after baseline ] [ Designated as safety issue: No ]Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.
- Radiographic bone level [ Time Frame: Up to 5 years after baseline ] [ Designated as safety issue: No ]Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.
| Estimated Enrollment: | 44 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Type 1 implant placement
Implant is placed immediately following tooth extraction in one surgical procedure
|
Procedure: Placement of a dental implant
Type 1 implant placement Type 2 implant placement
Other Names:
|
|
Active Comparator: Type 2 implant placement
Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure.
|
Procedure: Placement of a dental implant
Type 1 implant placement Type 2 implant placement
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 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.
- 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.
- Following extraction, surgical site anatomy presents conditions allowing immediate implant placement.
- Primary stability of implant consistent with standards of care is achieved at the time of placement.
Exclusion Criteria:
- Patient reports 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 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 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 coumadin (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.
- 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.
- 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
- Patient currently undergoing chemotherapy
- Patient history of radiation treatment to the head or neck
- Physical or mental handicaps that would interfere with patient's ability to exercise good oral hygiene on a regular basis
- Use of any investigational drug or device within the 30 day period immediately prior to implant surgery
- Patient is pregnant
- Extraction sites having anatomic conditions that preclude immediate implant placement.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623739
Contacts
| Contact: Guy Huynh-Ba, DDS,MS | 210-567-3569 | huynhba@uthscsa.edu |
Locations
| United States, Texas | |
| Graduate Periodontics, Dental School, UTHSCSA | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Guy Huynh-Ba, DDS, MS huynhba@uthscsa.edu | |
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Institut Straumann AG
Investigators
| Principal Investigator: | Guy Huynh-Ba, DDS, MS | UTHSCSA Department of Periodontics |
More Information
No publications provided
| Responsible Party: | Guy Huynh-Ba, Assistant Professor, The University of Texas Health Science Center at San Antonio |
| ClinicalTrials.gov Identifier: | NCT01623739 History of Changes |
| Other Study ID Numbers: | ITI 689_2010 |
| Study First Received: | April 26, 2012 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The University of Texas Health Science Center at San Antonio:
|
Dental implants Esthetic score Immediate implants Early placement |
Additional relevant MeSH terms:
|
Jaw, Edentulous Jaw, Edentulous, Partially Mouth, Edentulous Jaw Diseases |
Musculoskeletal Diseases Stomatognathic Diseases Mouth Diseases Tooth Diseases |
ClinicalTrials.gov processed this record on May 21, 2013