Immediate or Delayed Provisionalization in Posterior Healed Sites

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Non-inferiority Study of Immediate or Delayed Provisionalization at Posterior Healed Sites Using NobelParallelCC Implants

Conditions
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Partial Edentulism

Intervention / Treatment
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* Procedure: Immediate provisionalization
* Procedure: Delayed provisionalization
* Device: NobelParallel CC implant
* Device: Dental crown


Participation Criteria
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Eligibility Criteria
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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%)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate provisionalization<br>Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery | Procedure: Immediate provisionalization<br>* Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.<br>Device: NobelParallel CC implant<br>* Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.<br>* Other names: NobelParallel Conical Connection implant;Device: Dental crown<br>* A tooth-shaped cap that is placed over a tooth or implant for teeth restoration and improvement in appearance.<br>* Other names: Dental prosthetics;|
| Active Comparator: Delayed provisionalization<br>Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery | Procedure: Delayed provisionalization<br>* Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.<br>Device: NobelParallel CC implant<br>* Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.<br>* Other names: NobelParallel Conical Connection implant;Device: Dental crown<br>* A tooth-shaped cap that is placed over a tooth or implant for teeth restoration and improvement in appearance.<br>* Other names: Dental prosthetics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Bone Level Mesial to the Implant | 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. | Baseline and 6 months | 
| Radiographic Bone Level Mesial to the Implant | 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 | 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 | 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 | Measurements of peri-implant mucosal margin levels will be measured at baseline and 6 months post-procedure. | Baseline and 6 months | 
| Mean Change in Peri-implant Mucosal Margin Level | 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 | Measurements of peri-implant mucosal margin levels will be measured at 6 months and 12 months post-procedure. | 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental implants, Partial edentulism, Immediate/delayed provisionalization