Immediate or Delayed Provisionalization in Posterior Healed Sites

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

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.

Study Overview

• Status: Completed
• Conditions: Partial Edentulism
• Intervention / Treatment: Procedure: Immediate provisionalization; Device: NobelParallel CC implant; Device: Dental crown; Procedure: Delayed provisionalization

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: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University College of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

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

Collaborators and Investigators

• Sponsor: Columbia University
• 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): March 1, 2015
• Primary Completion (Actual): February 13, 2019
• Study Completion (Actual): February 13, 2019

Study Registration Dates

• First Submitted: February 27, 2015
• First Submitted That Met QC Criteria: March 9, 2015
• First Posted (Estimate): March 13, 2015

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Dental implants; Partial edentulism; Immediate/delayed provisionalization
• Other Study ID Numbers: AAAO5901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No