Partial EdentulismNCT02387970

Immediate or Delayed Provisionalization in Posterior Healed Sites

A study testing Immediate provisionalization, Delayed provisionalization and NobelParallel CC implant in people with Partial Edentulism, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Partial Edentulism
What is being tested?: Immediate provisionalization, Delayed provisionalization and NobelParallel CC implant
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteUnited States
Study dates: Mar 2015to 13 Feb 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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%)

Trial locations and contacts

1 site in 1 country.

United States1 site

Columbia University College of Dental Medicine
New York, New York, 10032

Other trials in United States

About this study

Official title: 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.

Read the 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).

Conditions: Partial Edentulism
Being tested: Immediate provisionalization, Delayed provisionalization, NobelParallel CC implant, Dental crown
Keywords: Dental implants, Partial edentulism, Immediate/delayed provisionalization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Immediate provisionalizationProcedure or 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.
Delayed provisionalizationProcedure or surgery
Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.
NobelParallel CC implantDevice
Also called NobelParallel Conical Connection implant
Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
Dental crownDevice
Also called Dental prosthetics
A tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.

Study groups in NCT02387970
Study group	Role	What they receive
Immediate provisionalization	Active comparator	Individuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery Receives: 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 Receives: Procedure: Delayed provisionalization; Device: NobelParallel CC implant; Device: Dental crown

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 months

Secondary outcomes (3)

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.
Measured: 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.
Measured: 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.
Measured: 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 201513 Feb 2019

First posted13 Mar 2015 (estimated)
Study startMar 2015
Primary completion13 Feb 2019
Study completion13 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Partial EdentulismStudies of the same condition, open and under way.
More trials run by Columbia UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02387970
Sponsor's protocol ID: AAAO5901
Status last verified: Feb 2023
First submitted: 27 Feb 2015
Last updated: 6 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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.
PubMed 6838955
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.
PubMed 20467608
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.
PubMed 8007025
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.
PubMed 32757387

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
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Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
Partial Edentulism Class 1 or Class 2
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Active, not recruiting
Clinical Fit of Conventionally Cast and 0° SLM Removable Partial Denture Frameworks
Partial Edentulism Class 3, Removable Partial Denture
Active, not recruitingObservational study
Survival of Implant-Supported All-Ceramic Prostheses
Partial Edentulism, Disorder of Prostheses and Implants

All Partial Edentulism trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-inferiority Study of Immediate or Delayed Provisionalization at Posterior Healed Sites Using NobelParallelCC Implants
ClinicalTrials.gov ID: NCT02387970
Acronym / sponsor ID: AAAO5901
Conditions: Partial Edentulism
Keywords: Dental implants, Partial edentulism, Immediate/delayed provisionalization
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Study start: Mar 2015 (actual)
Primary completion: 13 Feb 2019 (actual)
Study completion: 13 Feb 2019 (actual)
First posted: 13 Mar 2015 (estimated)
Results: Posted 27 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Immediate provisionalization	Active comparator	Procedure: Immediate provisionalization, Device: NobelParallel CC implant, Device: Dental crownIndividuals will receive temporary dental crowns supported by NobelParallel CC implant at the same day as implant surgery
Delayed provisionalization	Active comparator	Procedure: Delayed provisionalization, Device: NobelParallel CC implant, Device: Dental crownIndividuals will receive temporary dental crowns supported by NobelParallel CC implant 3 months after implant surgery

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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%)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Immediate provisionalizationStage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.	Procedure or surgery	Immediate provisionalization
Delayed provisionalizationStage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.	Procedure or surgery	Delayed provisionalization
NobelParallel CC implantAlso: NobelParallel Conical Connection implantSupports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.	Device	Delayed provisionalization, Immediate provisionalization
Dental crownAlso: Dental prostheticsA tooth-shaped "cap" that is placed over a tooth or implant for teeth restoration and improvement in appearance.	Device	Delayed provisionalization, Immediate provisionalization

Primary outcome

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.
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.
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.
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.

3 secondary outcomes

Mean Change in Peri-implant Mucosal Margin Level
Time frame: Baseline and 6 months
Mean Change in Peri-implant Mucosal Margin Level
Time frame: Baseline and 12 months
Mean Change in Peri-implant Mucosal Margin Level
Time frame: 6 months and 12 months

Results and safety

Results posted to the registry on 27 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Immediate Provisionalization	27	26
Delayed Provisionalization	25	23

Primary outcome: Radiographic Bone Level Mesial to the Implant

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: Millimeters

Measure	Immediate Provisionalization n = 24	Delayed Provisionalization n = 21
Value	1.26 (1.10)	1.85 (1.16)

Delayed Provisionalization: p = 0.088, t-test, 2 sided

Population analysed: Only includes individuals with analyzable data.

Primary outcome: Radiographic Bone Level Mesial to the Implant

Time frame: Baseline and 12 months. Mean (Standard Deviation). Unit: Millimeters

Measure	Immediate Provisionalization n = 25	Delayed Provisionalization n = 21
Value	1.14 (1.20)	1.57 (1.17)

Delayed Provisionalization: p = 0.235, t-test, 2 sided

Population analysed: Only includes individuals who completed the 1-year follow up.

Primary outcome: Radiographic Bone Level Distal to the Implant

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: Millimeters

Measure	Immediate Provisionalization n = 22	Delayed Provisionalization n = 20
Value	1.36 (1.27)	1.82 (0.76)

Delayed Provisionalization: p = 0.165, t-test, 2 sided

Population analysed: Only includes individuals with analyzable data.

Primary outcome: Radiographic Bone Level Distal to the Implant

Time frame: Baseline and 12 months. Mean (Standard Deviation). Unit: Millimeters

Measure	Immediate Provisionalization n = 23	Delayed Provisionalization n = 21
Value	1.22 (1.40)	1.60 (0.88)

Delayed Provisionalization: p = 0.297, t-test, 2 sided

Population analysed: Only includes individuals who completed the 1-year follow up.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 36 months from procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Immediate Provisionalization	0 of 26 (0%)	4 of 26 (15.4%)	4 of 26
Delayed Provisionalization	0 of 23 (0%)	3 of 23 (13%)	3 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 6838955Branemark 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.
Background: PubMed 20467608Esposito 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.
Background: PubMed 8007025Piattelli 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.
Derived from this study: PubMed 32757387Wang 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.
Individual participant dataSharing planned: No

Related trials for Partial Edentulism

Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Not yet recruiting
Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
Partial Edentulism Class 1 or Class 2
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Active, not recruiting
Clinical Fit of Conventionally Cast and 0° SLM Removable Partial Denture Frameworks
Partial Edentulism Class 3, Removable Partial Denture
Active, not recruitingObservational study
Survival of Implant-Supported All-Ceramic Prostheses
Partial Edentulism, Disorder of Prostheses and Implants

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Panos N Papapanou, DDS, PhD principal investigator

Columbia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Immediate provisionalization, Delayed provisionalization and NobelParallel CC implant in people with Partial Edentulism, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Bone Level Mesial to the Implant (time frame: Baseline and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02387970, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.