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Clinical Trials in Egypt / NCT07108361
Starting soon Not applicable

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

NCT07108361 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-09
Last updated
2025-08-11

Condition(s) studied

Implant OsseointegrationImplant OsteotomyImplant PlacementImplant Primary StabilityMolar Extraction SocketImmediate Implant Placement

Investigational drug(s) / intervention(s)

Osseodensificationconventional drilling

Osseodensification: 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: 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

Study summary

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

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: * 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. * Patients who can come for the follow-up visit. * Patients who provide written informed consent Exclusion Criteria: * Pregnancy. * Smoking * Patients with previously failed dental implants at the implant placement site. * Patients with active infections. * Other medical conditions that might affect the osseointegration of dental implants, such as diabetes, cardiovascular disease, hypertension, and osteoporosis

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ain Shams University Cairo Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07108361 on ClinicalTrials.gov ↗ ← All trials in Egypt