This trial is active, not recruiting.

Conditions jaw, edentulous, partially, acquired absence of single tooth
Treatment slactive implant
Sponsor The University of Texas Health Science Center at San Antonio
Collaborator ITI International Team for Implantology, Switzerland
Start date January 2013
End date October 2017
Trial size 43 participants
Trial identifier NCT02154581, HSC20130085H, ITI 799_2011


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
(Active Comparator)
In this group, immediate implant placement (Type 1) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed.
slactive implant Straumann
(Active Comparator)
In this group, immediate implant placement (Type 1) is performed including bone grafting of the void between the implant and the fresh extraction socket.
slactive implant Straumann

Primary Outcomes

Mid facial mucosal level at implant site
time frame: Up to 1 year after baseline

Secondary Outcomes

PES/WES (pink esthetic score, white esthetic score).
time frame: Up to 1 year after baseline
Probing depth
time frame: Up to 1 year after baseline
Modified Plaque Index
time frame: Up to 1 year after baseline
Modified Bleeding Index
time frame: Up to 1 year after baseline
Radiographic Bone Level
time frame: Up to 1 year 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 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.

Additional Information

Official title Case Selection and Treatment Protocol for Immediate Dental Implants in the Esthetic Zone: A Controlled Clinical Trial
Principal investigator Guy Huynh-Ba, DDS, MS
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio.