N/A
N=52
Immediate or Delayed Provisionalization in Posterior Healed Sites
Partial Edentulism
Bottom Line
View on ClinicalTrials.gov: NCT02387970 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Radiographic Bone Level Mesial to the Implant — 1.26; 1.85 Millimeters — p=0.088
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Immediate provisionalization (Procedure); Delayed provisionalization (Procedure); NobelParallel CC implant (Device); Dental crown (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiographic Bone Level Mesial to the Implant |
1.14; 1.57 | 0.235 |
| PRIMARY Radiographic Bone Level Mesial to the Implant |
1.14; 1.57 | 0.235 |
| PRIMARY Radiographic Bone Level Distal to the Implant |
1.22; 1.60 | 0.297 |
| PRIMARY Radiographic Bone Level Distal to the Implant |
1.22; 1.60 | 0.297 |
| SECONDARY Mean Change in Peri-implant Mucosal Margin Level |
0.10; -0.08 | 0.854 |
| SECONDARY Mean Change in Peri-implant Mucosal Margin Level |
0.10; -0.08 | 0.854 |
| SECONDARY Mean Change in Peri-implant Mucosal Margin Level |
0.10; -0.08 | 0.854 |
Summary
In this study, the investigators will examine the performance of a new dental implant that has been approved by the Food and Drug Administration for use to replace of missing teeth. The investigators will study two groups of patients: one group will receive a temporary crown to replace the missing tooth at the same day as implant surgery; the second group will receive a similar crown 3 months later. Both groups will receive a permanent crown on the implant 4 months after surgery, and will be followed up for a period of 12 months. The investigators want to examine whether the healing of the bone and gums surrounding the implant that receives a crown immediately is similar to the healing of the implant when the crown is delivered later. If this is indeed the case, then the investigators will be able to recommend faster treatment for all patients.
Eligibility Criteria
Inclusion Criteria
- 50 subjects will be recruited among those referred to the Columbia University College of Dental Medicine for tooth replacement using a dental implant in a posterior maxillary or mandibular region (premolar/molar area)
- Age 18 or older
- Healed extraction sockets (extraction carried out at least 3 months prior to recruitment)
- Implant site free of infection
- Systemically healthy patients or with controlled common systemic conditions
- Adjacent teeth present both mesially and distally to the implant site
Exclusion Criteria
- Pregnancy or intent to be pregnant over the next 12 months
- Current smoking exceeding 10 cigarettes/day
- Parafunctional habits/ excessive occlusal forces
- Current orthodontic therapy
- Uncontrolled hypertension (blood pressure over 160/100) or poorly-controlled diabetes (HbA1c>8%)
Data sourced from ClinicalTrials.gov (NCT02387970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.