"Osseodensification Efficacy on Molar Septum Expansion in Immediate Molar Implant Placement

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorAin Shams University

About this trial

The ideal positioning of immediate implants in molar extraction sockets often requires the osteotomy to be in the interradicular septum, which can be challenging in some cases, with traditional site preparation techniques. Also, the alveolar ridge undergoes various remodeling processes following tooth extraction, resulting in hard and soft tissue loss which complicates prosthodontic rehabilitation. Immediate implant placement help preserve the alveolar ridge dimensions and buccal ridge contour. While osseodensification has shown promise in enhancing primary stability and bone microarchitecture, its clinical and microstructural effects in molar extraction sockets remain underexplored. Although there is ample documentation of information on the temperature that is generated during preparation of implant sites, there are no studies available in the literature comparing conventional drilling and osseodensification techniques; therefore, the present investigation was aimed at analyzing the efficacy of osseodensification compared to conventional drilling in terms of bone dimensions preservation , changes in bone architecture during implant site preparation and heat generation to define which technique can be safely applied to achieve the necessary implant primary stability without damaging the surrounding bone.

Aim of the study:

Is to compare the molar septum dimensions using osseodensification expansion versus the conventional drilling protocol and to assess the role of jumping gap grafting in preservation of the alveolar ridge dimensions and buccal ridge contour in addition to Evaluation of the effect of osseodensification on the bony micro-architecture and heat generation

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients requiring placement in the posterior region.

ASA I and II patients who can undergo immediate implant placement and restorative procedures.

Both males and females.

Patient's age: 18-50 years old.

Disqualifiers

Pregnancy.

Smoking

Patients with previously failed dental implants at the implant placement site.

Patients with active infections.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Osseodensification

    Procedure/Surgery

    Septum width will be directly measured post molar extraction confirming the premeasure of the CBCT. Measurement will be recorded at the narrowest width of the septum. Implant site preparation starts with a pilot drill, in clockwise motion, in the center of the septum, until 1 mm deeper than the planned implant length. Densah® Burs (Versah, LLC, Jackson, MI, USA) were then sequentially used in OD mode (counterclockwise, drilling speed 800-1500 rpm, with copious irrigation) in small increments to gradually expand the osteotomy, until reaching the desired width for the planned implant diameter, Osteotomy diameter as a reflection of septum width expansion will then be directly measured and recorded after site instrumentation. Implants of adequate diameter (4, 4.5, or 5mm) and length (selected using preoperative CBCT) will be inserted in the prepared osteotomies to engage the bone apical to the socket, insertion torque will be measured using the torque wrench and ISQ values

  • conventional drilling

    Procedure/Surgery

    Septum width will be directly measured post molar extraction confirming the premeasure of the CBCT. Measurement will be recorded at the narrowest width of the septum. The initial (pointed) drill will be used to make a hole (starting point) in the interradicular bone to avoid slippage of the subsequent the drills in the socket of the remaining roots. The drills of increasing diameters will be used to complete the implant osteotomy according to manufacturer instructions. In case of limited interradicular bone volume, drilling will be made at the socket of mesial or distal roots. Osteotomy diameter as a reflection of septum width expansion will then be directly measured and recorded after site instrumentation. Implants of adequate diameter (4, 4.5, or 5mm) and length (selected using preoperative CBCT) will be inserted in the prepared osteotomies to engage the bone apical to the socket insertion torque will be measured using the torque wrench and ISQ values

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: conventional drilling groupActive comparator 1 intervention
Group B: Osseodensification groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Clinical assessment of molar septum dimensional changes of the extraction socket following osseodensification and conventional drilling protocols

Septum width will be directly measured post molar extraction. Measurement will be recorded at the narrowest width of the septum Osteotomy diameter as a reflection of septum width expansion will then be directly measured and recorded after site instrumentation

Time frame
from enrollment to the day of surgery

Secondary outcomes

1

Comparing of Residual bone volume bony Micro-architecture following osseodensification and conventional drilling protocols.

Micro-CT imaging osteotomy sites bone samples will be performed using a SkyScan 1272 microfocus X-ray system (SkyScan®, Kontich, Belgium) with software including NRecon reconstruction®, CTAn 1.8®, and CTvol. In this study, the X-ray source will be set at 70 kV and 100μA with the pixel size of 6μm, a 0.5-mm filter, and a tomographic rotation of 180° (rotation step of 0.2°). Residual bone volume (BV, μm3) around osteotomy sites will be quantified and 3-D models will be generated

Time frame
Day of surgery
2

Comparing amount of heat generation following osseodensification and conventional drilling protocols.

Time frame
from enrollment to the day of surgery
3

Assessment of the clinical outcomes of implant placement in the extraction socket comparing the two drilling protocols

Implant ISQ values (implant stability Quotient )

Time frame
All parameters will be assessed immediately after implant placement (T0), six months (T6) and 12 months (T12)
4

Radiographic assessment of molar septum dimensional changes of the extraction socket following osseodensification and conventional drilling protocols

changes in vertical height and horizontal width of the septum bone

Time frame
All parameters will be assessed immediately after implant placement (T0), six months (T6) and 12 months (T12)

Other outcomes

Sponsors and contacts

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Ain Shams University

Lead sponsor

Augusta University

Collaborator