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Implant StabilityNCT04345133

Effect of Undersized Drilling Upon the Immediate Implants

A study testing Dental Implants Insertion Drilling Sequence in people with Implant Stability, run by University of Carabobo.

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

OBJECTIVE: evaluate the effect of undersized drilling upon the primary and secondary stability of immediate implants placed in the anterior sector maxilla. PATIENTS AND METHODS Study design A randomized comparative clinical trial was carried out. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Implant Stability
What is being tested?
Dental Implants Insertion Drilling Sequence
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
9 Jan 2017to 17 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • indication of one or more immediate implants in the anterior maxilla; No history of ischemic heart disease, No History of uncontrolled diabetes, No coagulation disorders, No head or neck radiotherapy

Who cannot join

  • Periodontal Disease. History of EV or Oral Bisphosphonate

About this study

Official title: Effect of Undersized Drilling Upon the Primary and Secondary Stability of Immediate Conical Implants in the Esthetic Maxillary Sector

OBJECTIVE:

evaluate the effect of undersized drilling upon the primary and secondary stability of immediate implants placed in the anterior sector maxilla.

Read more

PATIENTS AND METHODS Study design A randomized comparative clinical trial was carried out. Thirty conical MIS C1 grade 23 titanium alloy (Ti 6Al 4V Eli) implants with a rough surface subjected to dual acid etching and sandblasting, measuring 3.75 mm in maximum diameter and 13 mm in length (MIS® Implants Technologies, Ltd. Bar Levi, Israel), were placed immediately after removal a anterior maxillary tooth in a series of patients treated in the clinic of the Master of Dentistry and Dental Implantology (Santa María University, Dental School, Caracas, Venezuela). The study was approved by the local Ethics Committee.

Patient selection To enrolled in the study, patients had to comply the inclusion/exclusion criteria established to the study: over 18 years of age with indication of one or more immediate implants in the anterior maxilla; no history of ischemic heart disease, uncontrolled diabetes, coagulation disorders, head or neck radiotherapy, intravenous bisphosphonates or uncontrolled periodontal disease. Based on a CTCB evaluation, the teeth involved should have presence of bone ≥ 5 mm from the tooth apex to the lower cortical layer of the nasal fossa / maxillary sinus and no vertical defects greater than 4 mm at the buccal or palatine alveolar crest. Also, patients must have capacity to understand the study protocol and fill consent form to participation in the study.

Study procedure Two operators calibrated for immediate implant placement performed minimally traumatic tooth extraction following local infiltrating anesthesia with 4% articaine and 1:100,000 epinephrine (Artheek® 4%, New Stetic S.A.; Antioquia, Colombia). After evaluating the integrity of the bone walls, drilling sequence was established on a randomized basis.

Conventional drilling (CD) sequence:

  • Marking drill ∅1.9 mm at 1500 rpm
  • Pilot drill ∅ 2.4 mm and 13 mm in length at 800 rpm.
  • Twist drill ∅3 mm at 400 rpm.

Undersized drilling (UD) sequence:

Marking drill ∅1.9 mm at 1500 rpm Pilot drill ∅ 2.4 mm and 13 mm in length at 400 rpm. Implant insertion A surgical motor (MCU MIS, model M0132, W\&H, Burmoos, Austria) with a 20:1 reducing implant handpiece was used to insert the implants at 20 rpm and applying a torque of 10 Ncm. Following placement of the implant in the bed, manual insertion was continued to reach the final implant position, established as 4 mm from the gingival margin.

Study variables Two torque meters (MIS® Implants LTD, models MT-RI040 and MT-RT070, Bar Levi, Israel) were used to insert and sequentially measure the maximum IT reached on positioning the implant in the socket. A Smart-peg Nro 49 model 100480 was fitted to the connection of each implant and an Osstell ISQ® (SN 4669 Osstell AB, Goteborg, Sweden) was used to perform RFA analysis and obtain corresponding ISQ value at insertion time (RFA1). A 4 mm height healing screw was used to seal the implant, and then additional RFA measurements was made at 6 week (RFA2) and 12 week (RFA3) post-implantation

Being tested
Dental Implants Insertion Drilling Sequence
Keywords
Primary Stability, Secondary Stability, Undersized Drilling

What participants receive

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

  • Dental Implants Insertion Drilling SequenceDevice

    Drilling sequence protocol to insert immediate Dental Implants at the Maxilla.

Study groups in NCT04345133
Study groupRoleWhat they receive
Undersized Drilling GroupActive comparatorExposed patients to the reduction of the final drill dimensions at the insertion implants protocol sequence
Receives: Device: Dental Implants Insertion Drilling Sequence
Conventional Drilling GroupOtherGroup with the conventional protocol recommended by the manufacturer
Receives: Device: Dental Implants Insertion Drilling Sequence

What is being measured

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

  1. Insertion Torque

    Maximum torque in N.cm obtained during insertion of the implant

    Measured: at baseline, through study completion in average 1 year

  2. RFA Implant Stability

    Implant Stability measure by Radio-Frequency Analysis.

    Measured: at baseline, through study completion in average 1 year

Secondary outcomes (2)
  1. RFA2 Implant Stability

    Implant Stability measure by Radio-Frequency Analysis 6 weeks later

    Measured: 6 weeks after baseline, trough study completion in average 1 year

  2. RFA3 Implant Stability

    Implant Stability measure by Radio-Frequency Analysis 12 weeks later

    Measured: 12 weeks after baseline, trough study completion in average 1 year

Timeline

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

  1. First posted14 Apr 2020
  2. Study start9 Jan 2017
  3. Primary completion17 Dec 2017
  4. Study completion17 Mar 2018

Resources

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
Single group
Model description
Comparative
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04345133
Sponsor's protocol ID
UCarabobo
Status last verified
Apr 2020
First submitted
9 Apr 2020
Last updated
14 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The study protocol is included in the medical records of the postgraduate degree and there are identity protection policies.

Publications

  • Sierra-Rebolledo A, Allais-Leon M, Maurette-O'Brien P, Gay-Escoda C. Primary Apical Stability of Tapered Implants Through Reduction of Final Drilling Dimensions in Different Bone Density Models: A Biomechanical Study. Implant Dent. 2016 Dec;25(6):775-782. doi: 10.1097/ID.0000000000000479.

    PubMed 27540846

Questions about this trial

What is this clinical trial studying?

A study testing Dental Implants Insertion Drilling Sequence in people with Implant Stability, run by University of Carabobo.

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 1 inclusion and 1 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 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Insertion Torque (time frame: at baseline, through study completion in average 1 year). The study lists 2 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 NCT04345133, which also lists 1 linked publication.

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 14 Apr 2020.

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