Acquired Absence of Single Tooth, Jaw, Edentulous, Partially
Conditions
Keywords
Dental implants, Esthetic score, Immediate implants, Early placement
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.
Interventions
PROCEDUREPlacement of a dental implant
Type 1 implant placement Type 2 implant placement
Sponsors
Institut Straumann AG
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mid Facial Mucosal Level at Implant Site | 3 months after crown delivery | 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
| Measure | Time frame | Description |
|---|---|---|
| PES/WES (Pink Esthetic Score, White Esthetic Score). | 3, 6, 12, 24, 36, 48, 60 months after crown delivery | The PES and WES scales are 10 point scales, made up of 5 categories, each with a 2 point value. Each category is scored out of 2, and the scores totaled to give an optimal score out of 10. Any score of 6 or higher out of 10 would be considered a good clinical outcome. the PES categories focus on the gum area, and the WES categories focus on the tooth. The scores for PES and WES are totaled, to give a score out of 20, with 20 being the highest possible score (best outcome). The values are totaled and a mean score of all the readings is reported. |
| Probing Depth | 3, 6, 12, 24, 36, 48, 60 months after crown delivery | The measurement of the pocket around the implanted tooth, measured with a graduated probe. A healthy pocket depth is around 3mm with no bleeding during the measurement process. The values are totaled and a mean score of all the readings is reported. |
| Modified Plaque Index | 3, 6, 12, 24, 36, 48, 60 months after crown delivery | Measurement of amount of plaque build-up on teeth, using a scale of 0 (no plaque detection), to 3 (an abundance of soft matter). The scores are totaled and a mean score reported. |
| Modified Bleeding Index | 3, 6, 12, 24, 36, 48, 60 months after crown delivery | Bleeding from the gums is measured on probing the gum and measured on scale of 0 to 5, with 0 being the best outcome, with no bleeding, and 5 being the worst outcome, with spontaneous bleeding. The scores are totaled and a mean score reported. |
| Radiographic Bone Level | Up to 5 years after baseline | Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Type 1 Implant Placement Implant is placed immediately following tooth extraction in one surgical procedure
Placement of a dental implant: Type 1 implant placement Type 2 implant placement | 17 |
| 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.
Placement of a dental implant: Type 1 implant placement Type 2 implant placement | 15 |
| Total | 32 |
Baseline characteristics
| Characteristic | Type 2 Implant Placement | Total | Type 1 Implant Placement |
|---|---|---|---|
| Age, Continuous | 50.9 years STANDARD_DEVIATION 14.6 | 51.8 years STANDARD_DEVIATION 14.9 | 52.5 years STANDARD_DEVIATION 15.6 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 15 participants | 32 participants | 17 participants |
| Sex: Female, Male Female | 6 Participants | 14 Participants | 8 Participants |
| Sex: Female, Male Male | 9 Participants | 18 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 15 |
| other Total, other adverse events | 0 / 17 | 2 / 15 |
| serious Total, serious adverse events | 0 / 17 | 0 / 15 |
Outcome results
Primary
Mid Facial Mucosal Level at Implant Site
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.
Time frame: 3 months after crown delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Implant Placement | Mid Facial Mucosal Level at Implant Site | 0.54 mm | Standard Deviation 0.18 |
| Type 2 Implant Placement | Mid Facial Mucosal Level at Implant Site | 0.47 mm | Standard Deviation 0.31 |
Secondary
Modified Bleeding Index
Bleeding from the gums is measured on probing the gum and measured on scale of 0 to 5, with 0 being the best outcome, with no bleeding, and 5 being the worst outcome, with spontaneous bleeding. The scores are totaled and a mean score reported.
Time frame: 3, 6, 12, 24, 36, 48, 60 months after crown delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Implant Placement | Modified Bleeding Index | 0.12 units on a scale | Standard Error 0.08 |
| Type 2 Implant Placement | Modified Bleeding Index | 0.07 units on a scale | Standard Error 0.07 |
Secondary
Modified Plaque Index
Measurement of amount of plaque build-up on teeth, using a scale of 0 (no plaque detection), to 3 (an abundance of soft matter). The scores are totaled and a mean score reported.
Time frame: 3, 6, 12, 24, 36, 48, 60 months after crown delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Implant Placement | Modified Plaque Index | 0.18 units on a scale | Standard Error 0.1 |
| Type 2 Implant Placement | Modified Plaque Index | 0.27 units on a scale | Standard Error 0.15 |
Secondary
PES/WES (Pink Esthetic Score, White Esthetic Score).
The PES and WES scales are 10 point scales, made up of 5 categories, each with a 2 point value. Each category is scored out of 2, and the scores totaled to give an optimal score out of 10. Any score of 6 or higher out of 10 would be considered a good clinical outcome. the PES categories focus on the gum area, and the WES categories focus on the tooth. The scores for PES and WES are totaled, to give a score out of 20, with 20 being the highest possible score (best outcome). The values are totaled and a mean score of all the readings is reported.
Time frame: 3, 6, 12, 24, 36, 48, 60 months after crown delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Implant Placement | PES/WES (Pink Esthetic Score, White Esthetic Score). | 13.67 units on a scale | Standard Error 0.61 |
| Type 2 Implant Placement | PES/WES (Pink Esthetic Score, White Esthetic Score). | 12.51 units on a scale | Standard Error 0.65 |
Secondary
Probing Depth
The measurement of the pocket around the implanted tooth, measured with a graduated probe. A healthy pocket depth is around 3mm with no bleeding during the measurement process. The values are totaled and a mean score of all the readings is reported.
Time frame: 3, 6, 12, 24, 36, 48, 60 months after crown delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Type 1 Implant Placement | Probing Depth | 3.06 mm | Standard Error 0.18 |
| Type 2 Implant Placement | Probing Depth | 2.93 mm | Standard Error 0.18 |
Secondary
Radiographic Bone Level
Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.
Time frame: Up to 5 years after baseline
Population: No data were collected or analyzed for this outcome measure