Immediate or Delayed Provisionalization in Posterior Healed Sites

NCT02387970 | Completed Results FDA Device

• 1 other identifier: AAAO5901
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Partial Edentulism

Keywords

Dental implants; Partial edentulism; Immediate/delayed provisionalization

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Mean Change in Peri-implant Mucosal Margin Level

  Baseline and 6 months

• Mean Change in Peri-implant Mucosal Margin Level

  Baseline and 12 months

• Mean Change in Peri-implant Mucosal Margin Level

  6 months and 12 months

Study Arms (2)

Immediate provisionalization

ACTIVE COMPARATOR

Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery

Procedure: Immediate provisionalization; Device: NobelParallel CC implant; Device: Dental crown

Delayed provisionalization

ACTIVE COMPARATOR

Individuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery

Procedure: Delayed provisionalization; Device: NobelParallel CC implant; Device: Dental crown

Interventions

Immediate provisionalization PROCEDURE

Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.

Immediate provisionalization

Delayed provisionalization PROCEDURE

Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.

Delayed provisionalization

NobelParallel CC implant DEVICE

Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.

Also known as: NobelParallel Conical Connection implant

Delayed provisionalization; Immediate provisionalization

Dental crown DEVICE

A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.

Also known as: Dental prosthetics

Delayed provisionalization; Immediate provisionalization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University College of Dental Medicine

New York, New York, 10032, United States

Location

Related Publications (4)

• 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.

  PMID: 6838955 BACKGROUND

• 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.

  PMID: 20467608 BACKGROUND

• 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.

  PMID: 8007025 BACKGROUND

• 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.

  PMID: 32757387 DERIVED

MeSH Terms

Interventions

Crowns

Intervention Hierarchy (Ancestors)

Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Results Point of Contact

• Title: Panos N. Papapanou, DDS, PhD
• Organization: Columbia University

pp192@cumc.columbia.edu

(212) 342-3008

Study Officials

• Panos N Papapanou, DDS, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dental Medicine

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 13, 2015
• Study Start: March 1, 2015
• Primary Completion: February 13, 2019
• Study Completion: February 13, 2019
• Last Updated: March 6, 2023
• Results First Posted: January 27, 2020

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)