Overview

This trial is active, not recruiting.

Conditions jaw, edentulous, partially, acquired absence of single tooth
Treatment placement of a dental implant
Sponsor The University of Texas Health Science Center at San Antonio
Collaborator Institut Straumann AG
Start date December 2010
End date December 2016
Trial size 44 participants
Trial identifier NCT01623739, ITI 689_2010

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Implant is placed immediately following tooth extraction in one surgical procedure
placement of a dental implant Straumann
Type 1 implant placement Type 2 implant placement
(Active Comparator)
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.
placement of a dental implant Straumann
Type 1 implant placement Type 2 implant placement

Primary Outcomes

Measure
Mid facial mucosal level at implant site
time frame: Up to 5 years after baseline

Secondary Outcomes

Measure
PES/WES (pink esthetic score, white esthetic score).
time frame: Up to 5 years after baseline
Probing depth
time frame: Up to 5 years after baseline
Modified plaque index
time frame: Up to 5 years after baseline
Modified bleeding index
time frame: Up to 5 years after baseline
Radiographic bone level
time frame: Up to 5 years after baseline

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Esthetic, Clinical and Radiographic Outcomes of Immediately Placed Implants (Type 1) and Early Placed Implants (Type 2)
Principal investigator Guy Huynh-Ba, DDS, MS
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio.