- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02387970
Immediate or Delayed Provisionalization in Posterior Healed Sites
Non-inferiority Study of Immediate or Delayed Provisionalization at Posterior Healed Sites Using NobelParallelCC Implants
Study Overview
Status
Conditions
Detailed Description
Dental implants are a widely used treatment option for the replacement of lost teeth due to trauma or oral diseases. The original protocol for placement of dental implants in edentulous spaces in the maxilla or the mandible was introduced more than thirty years ago and called for a two-stage approach, i.e., surgical placement of submerged dental implants and subsequent uncovering with abutment connection, prosthesis fabrication and functional loading approximately 6 months after. Today, the time between surgery and loading in a two-stage protocol has been commonly abbreviated to 3-4 months, while immediate implant provisionalization has emerged as a reliable and predictable option in cases of adequate osseous support, having similar survival and success rates to the two-step procedure. Comparison of histological healing has demonstrated no significant differences in bone to implant contact between implants surgically placed according to a two-stage protocol and those immediately provisionalized. However, substantial variability was noted among the clinical protocols used in the studies carried out so far, and additional well-designed randomized controlled trials (RCTs) are needed to fully appreciate the clinical outcomes of immediate and early loading protocols.
The design of dental implants is a subject of continuous improvement, and implant manufacturers regularly introduce new products the use of which may result in accelerated soft and hard tissue healing, increased initial implant stability, and enhanced aesthetic outcomes. The purpose of this randomized, controlled trial is to compare treatment outcomes when using a newly-introduced dental implant (NobelParallel™ CC) in a one-stage or a two-stage protocol. This new implant has the same titanium oxide surface coating (TiUnite®) and the same design principles of the parallel-walled NobelSpeedy Groovy™ implants, and an internal conical connection. The implant is marketed under the premarket notifications K050406 and K073142 (510(k), Food and Drug Administration).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10032
- Columbia University College of Dental Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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%)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Immediate provisionalization
Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery
|
Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.
Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Other Names:
A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
Other Names:
|
Active Comparator: Delayed provisionalization
Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery
|
Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Other Names:
A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.
Other Names:
Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiographic Bone Level Mesial to the Implant
Time Frame: Baseline and 6 months
|
Radiographic measurements of alveolar bone level mesial to the implant (at surgical placement and 6 months) will be carried out using the MIPACS software.
The implant platform will be the reference point.
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Baseline and 6 months
|
Radiographic Bone Level Mesial to the Implant
Time Frame: Baseline and 12 months
|
Radiographic measurements of alveolar bone level mesial to the implant (at surgical placement and 12 months) will be carried out using the MIPACS software.
The implant platform will be the reference point.
|
Baseline and 12 months
|
Radiographic Bone Level Distal to the Implant
Time Frame: Baseline and 6 months
|
Radiographic measurements of alveolar bone level distal to the implant (at surgical placement and 6 months) will be carried out using the MIPACS software.
The implant platform will be the reference point.
|
Baseline and 6 months
|
Radiographic Bone Level Distal to the Implant
Time Frame: Baseline and 12 months
|
Radiographic measurements of alveolar bone level distal to the implant (at surgical placement and 12 months) will be carried out using the MIPACS software.
The implant platform will be the reference point.
|
Baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Peri-implant Mucosal Margin Level
Time Frame: Baseline and 6 months
|
Measurements of peri-implant mucosal margin levels will be measured at baseline and 6 months post-procedure.
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Baseline and 6 months
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Mean Change in Peri-implant Mucosal Margin Level
Time Frame: Baseline and 12 months
|
Measurements of peri-implant mucosal margin levels will be measured at baseline and 12 months post-procedure.
|
Baseline and 12 months
|
Mean Change in Peri-implant Mucosal Margin Level
Time Frame: 6 months and 12 months
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Measurements of peri-implant mucosal margin levels will be measured at 6 months and 12 months post-procedure.
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6 months and 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Panos N Papapanou, DDS, PhD, Columbia University
Publications and helpful links
General Publications
- Branemark PI, Adell R, Albrektsson T, Lekholm U, Lundkvist S, Rockler B. Osseointegrated titanium fixtures in the treatment of edentulousness. Biomaterials. 1983 Jan;4(1):25-8. doi: 10.1016/0142-9612(83)90065-0.
- Esposito M, Grusovin MG, Chew YS, Coulthard P, Worthington HV. One-stage versus two-stage implant placement. A Cochrane systematic review of randomised controlled clinical trials. Eur J Oral Implantol. 2009 Summer;2(2):91-9.
- Piattelli A, Ruggeri A, Franchi M, Romasco N, Trisi P. An histologic and histomorphometric study of bone reactions to unloaded and loaded non-submerged single implants in monkeys: a pilot study. J Oral Implantol. 1993;19(4):314-20.
- Wang J, Lerman G, Bittner N, Fan W, Lalla E, Papapanou PN. Immediate versus delayed temporization at posterior single implant sites: A randomized controlled trial. J Clin Periodontol. 2020 Oct;47(10):1281-1291. doi: 10.1111/jcpe.13354. Epub 2020 Sep 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AAAO5901
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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