NCT07378020

Comparing Between Osseodensification Burs Versus Osteotome in Low Bone Density Areas.

A Comparative Study of Osseodensification Burs Versus Osteotome Preparation on the Stability of Implants Placed in Low Bone Density Areas: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Future University in Egypt · Academic / Other
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the primary stability of implant sites prepared using conventional drilling, osseodensification (Densah bur), and osteotome preparation techniques, and to evaluate the influence of these methods on implant success rates in areas of low bone density.

Detailed description

in different conditions implants that lack primary stability is subjected to excessive micromotion that can lead to implant failure. This usually happens when dental implants pass the critical limit of micro-motion. Passing this critical limit can interfere with Osseo-integration and cause fibrous encapsulation of dental implant . Implant Failure usually occurs in completely edentulous maxillae especially in the posterior area where bone quality is compromised. Clinicians usually refer implants success rates to the difference in bone quality between mandible and maxilla. Higher failure rates seem to be associated with poor bone quality. Primary stability is affected by several factors including Bone Quantity and quality, the Implant macro- and micro- design, and the used osteotomy technique. Osteotomies are usually created using conventional drills, although the implant diameter must be slightly larger than the final drill to ensure primary stability However, this conventional drilling technique might be insufficient to provide the primary stability required for Osseo-integration in areas of low bone quality. Several site preparation techniques have been introduced to enhance primary stability in soft bone. Some clinicians used under-sized drilling however the efficiency of this technique is conditioned by decreasing osteotomy diameter by 10% of implant diameter. Another method introduced by Dr. Robert Summer. This method uses bone condensers to densify bone through the condensation and expansion of spongy bone as it squeezes bone trabeculae laterally against the wall of implant bed at the site of osteotomy increasing the bone density and conserving osseous tissue around implants. Recently Osseodensification (OD) was introduced as a novel implant site preparation technique that uses specially designed drills with large negative rake angles. When the drills are operated in a counterclockwise direction it acts as a non-cutting drill which is used to expand and compact bone against the osteotomy walls. This non-subtractive approach aims to increase the primary stability of the dental implants inserted into low-density bone compared with conventional drilling techniques. The drills also can be used as a cutting drill when operated in a clockwise direction according to the operator's need. This type of drill can improve bone density leading to improved implant primary stability, giving these drills the ability to cut and densify without the need for additional tools. Ossoe-densification technique showed greater insertion torques, bone-to implant contact, and bone area fraction occupancy when compared to standard Drilling technique. this study is comparing between the three different drilling techniques (conventional, osseo-densification, osteotome bone compaction) in enhancing insertion torque and isq values in posterior maxillary area. the study also compare between the effect of these techniques on marginal bone loss with follow up 6 month after loading using cbct

Conditions

• Low Bone Density

Interventions

Type	Name	Description
PROCEDURE	Conventional Osteotomy	The implant site will be prepared using a standard sequence of drills (subtractive osteotomy) according to the implant manufacturer's instructions. Drilling will be performed with profuse irrigation at speed between 800-1200 rpm to remove bone and prepare the osteotomy site to the final diameter before implant insertion
PROCEDURE	Densah Bur drilling	after using the pilot drill in a clockwise direction to drill to the desired depth according to the planned implant length The implant site will be prepared using Densah burs (Versah). the motor is adjusted to rotate in a counter-clockwise direction (densifying mode) at 800-1200 rpm with profuse irrigation. This technique expands the osteotomy site by compacting bone at the periphery rather than removing it, aiming to enhance bone density around the implant then the implant is inserted after reaching the desired diameter according to densah bur soft bone drilling protocol
PROCEDURE	osteotome bone condensation	osteotomy was prepared using (Xive BoneCondensers by dentsply sirona GERMANY) starting from the pilot drill of 1.7mm in diameter to penetrate the cortical bone and gain access. Then instrumentation was done in the following sequence: 2.0mm, 3.0mm, and 3.4mm according to the planned implant diameter. The osteotome was inserted manually and rotated while being pressed towards the apical part of osteotomy till it reaches the full working depth. Once the desired depth was reached, and before moving to the next instrument we wait 1 min for the osteotome to compress and compact the spongy bone. After the implant bed had been prepared, we inserted the implant immediately to avoid any dimensional changes in the site of osteotomy.

Timeline

• Start date: 2024-01-05
• Primary completion: 2025-01-05
• Completion: 2025-12-15
• First posted: 2026-01-30
• Last updated: 2026-04-06

Locations

1 site across 1 country: Egypt