NCT02154581CompletedNot Applicable
Case Selection and Treatment Protocol for Immediate Dental Implants in the Esthetic Zone: A Controlled Clinical Trial
The University of Texas Health Science Center at San Antonio1 site in 1 country41 target enrollmentStarted: January 1, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Mid Facial Mucosal Level at Implant Site
Study Overview
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:
- 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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 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.
- •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.
- •The site to be treated is surrounded by two natural teeth.
- •Except the site to be treated, none of the maxillary incisors, canines and first pre-molars display marginal soft tissue recession.
- •Following extraction, intact extraction socket bony walls are present.
- •Primary stability of implant consistent with standards of care is achieved at the time of implant placement.
- •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
- •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.
- •History of alcoholism or drug abuse within the past 5 years.
- •Severe wear with an etiology of 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 (American Society of Anesthesiologists) 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 warfarin (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.
Arms & Interventions
Type 1 implant and thin biotype
Active Comparator
In this group, immediate implant placement (SLActive implant) 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.
Intervention: SLActive implant (Device)
Type 1 implant and thick biotype
Active Comparator
In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket.
Intervention: SLActive implant (Device)
Outcomes
Primary Outcomes
Mid Facial Mucosal Level at Implant Site
Time Frame: Change from Baseline to 3 months
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 months after crown delivery.
Secondary Outcomes
- Modified Plaque Index(Up to 1 year after baseline)
- PES/WES (Pink Esthetic Score, White Esthetic Score).(Approximately 1 year after baseline)
- Probing Depth(Up to 1 year after baseline)
- Radiographic Bone Level(Up to 1 year after baseline)
- Modified Bleeding Index(Up to 1 year after baseline)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Not Applicable
Immediate Implant Placement With Immediate Provisionalization Into Extraction Sockets With Labial Plate Dehiscence Defects Within the Maxillary Esthetic ZoneBadly Decayed Anterior Maxillary TeethNCT03676244Cairo University15
Recruiting
Not Applicable
Management of the Fresh Extraction Socket in the Aesthetic AreaDental ImplantBone AugmentationSoft Tissue AugmentationTooth Extraction Status NosNCT04367766Centro Specialistico Odontoiatrico, Rome60
Unknown
Not Applicable
Immediate Dental Implants in The Upper Anterior RegionTeeth LossAlveolar Bone ResorptionNCT06382337Mansoura University16
Completed
Not Applicable
Single Tooth Extraction in Damaged Alveoli and Implant Site Development:TootTooTooth Extraction Status NosNCT05235048The European Research Group on Periodontology (ERGOPerio)160
Completed
Not Applicable
Periapical Lesions and Immediate ImplantsPeriapical GranulomaOsseointegration Failure of Dental ImplantDental Implant Failure NosNCT06521203Akdeniz University25