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Effect of Undersized Drilling Upon the Immediate Implants

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04345133
Enrollment
30
Registered
2020-04-14
Start date
2017-01-09
Completion date
2018-03-17
Last updated
2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implant Stability

Keywords

Primary Stability, Secondary Stability, Undersized Drilling

Brief 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. 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

Interventions

DEVICEDental Implants Insertion Drilling Sequence

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

Sponsors

University of Carabobo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

No informaron about sequence of drilling was used to insert the implants

Intervention model description

Comparative

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Periodontal Disease. History of EV or Oral Bisphosphonate

Design outcomes

Primary

MeasureTime frameDescription
Insertion Torqueat baseline, through study completion in average 1 yearMaximum torque in N.cm obtained during insertion of the implant
RFA Implant Stabilityat baseline, through study completion in average 1 yearImplant Stability measure by Radio-Frequency Analysis.

Secondary

MeasureTime frameDescription
RFA2 Implant Stability6 weeks after baseline, trough study completion in average 1 yearImplant Stability measure by Radio-Frequency Analysis 6 weeks later
RFA3 Implant Stability12 weeks after baseline, trough study completion in average 1 yearImplant Stability measure by Radio-Frequency Analysis 12 weeks later

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026