New York, New York 10032


Purpose:

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 esthetic 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 summary:

Eligible participants (i.e., adults 18 years old in need of a dental implant at a posterior maxillary or mandibular region) who have been referred for dental implant treatment at the Clinics of the College of Dental Medicine will be approached by the study investigators and the aims of the study will be explained. Signed informed consent will be obtained. All patients will be referred for limited field cone beam computer tomography to assess presence of adequate bone volume at the area of interest, according to standard clinic protocol. Alginate impressions will be obtained to fabricate diagnostic stone casts. A vacuum-formed stent will be manufactured in the laboratory to offer fixed reference points for longitudinal probing measurements, and a radiographic stent using polyvinyl siloxane interocclusal record material will allow standardized positioning of the radiographic holder to obtain periapical radiographs with the same projection geometry. At the day of surgery (baseline), a computer-generated sequence will assign patients to either the one-stage or the twostage treatment arm. In both arms, the implant will be placed flush with the bone crest, after flap elevation, according to standard treatment protocol. A periapical radiograph will be obtained immediately after completion of surgery. Patients in the one-stage group will receive a temporary acrylic crown manufactured chair-side at the same visit. Care will be taken to relieve the crown from occlusal and laterotrusive contacts. The distance from the soft tissue margin to the occlusal stent will be measured using a periodontal probe at six sites around the implant (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual and distolingual) at the time of post-surgical follow-up, 1-2 weeks after surgery. At three months after implant surgery, patients in the two-stage group will have the implant uncovered after punching the oral mucosa, according to standard protocol. An acrylic temporary crown will be delivered. Soft tissue margin assessments measurements will be carried out, as described above, will be carried out at the time of post-surgical follow-up, 1-2 weeks after surgery. At four months after implant surgery, patients in both arms will have a final fixture level impression according to standard protocol for fabrication of the final implant supported restoration (a full contour Zirconia abutment crown with an angulated screw channel), which will be delivered approximately 2 weeks later. Resonance frequency analysis measurements will be obtained to determine implant stability using an Ostell™ device. At six months after implant surgery, patients in both treatment groups will return for a follow up visit to reinforce oral hygiene and will receive oral prophylaxis. Resonance frequency analysis measurements will be obtained to determine implant stability using an Ostell™ device. A periapical radiograph will be obtained, soft tissue margin measurements will be carried out as described above, and peri-implant probing depths will be assessed at the same six sites. An alginate impression will also be obtained to produce a stone cast to be used in volumetric measurements. At twelve months after implant surgery, patients in both treatment groups will return for a follow up visit to reinforce oral hygiene and to receive oral prophylaxis. Resonance frequency analysis measurements will be obtained to determine implant stability using an Ostell™ device. A periapical radiograph will be obtained, soft tissue margin measurements will be carried out as described above, and probing depths will be assessed at the same six sites around the implant. An impression will be obtained to produce a cast to be used in volumetric measurements. The 12-month examination will conclude the study visits.


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%)


NCT ID:

NCT02387970


Primary Contact:

Principal Investigator
Panos N Papapanou, DDS, PhD
Columbia University

Panos N Papapanou, DDS, PhD
Email: pp192@columbia.edu


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States

Panos N Papapanou, DDS, PhD
Phone: 212-342-3008
Email: pp192@cumc.columbia.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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