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Clinical Trials/NCT07378020
NCT07378020
Completed
Not Applicable

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

Future University in Egypt1 site in 1 country13 target enrollmentStarted: January 5, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
13
Locations
1
Primary Endpoint
Secondary Implant Stability using radio frequency analysis (RFA)

Overview

Brief 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Blinding was maintained throughout the clinical trial for all data collection and outcome assessments. Insertion torque and Implant Stability Quotient (ISQ) values were recorded immediately, 3 months post-surgery, and 6 months post-loading by two independent examiners who were not involved in the surgical procedures and were blinded to patient allocation. Additionally, radiographic outcomes-specifically marginal bone loss evaluated on CBCT images-were assessed by an independent professional who was strictly

Eligibility Criteria

Ages
35 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with low bone density (D3), (D4) Missing maxillary posterior teeth
  • edentulous ridge should be 8 mm or more of bone height and bone width ≥ 7mm with adequate inter-occlusal space of at least 8mm,
  • Patients with good oral hygiene or willing to improve their oral hygiene.

Exclusion Criteria

  • Patients with uncontrolled medical conditions that affect Osseo-integration.
  • Patients receiving medications that contraindicate osteotomy.
  • Heavy smokers.
  • History of receiving irradiation in the head and neck region.

Arms & Interventions

Conventional Drilling

Active Comparator

Implant sites in this arm will undergo osteotomy preparation using standard conventional drilling sequences according to the implant manufacturer's recommendations prior to implant placement

Intervention: Conventional Osteotomy (Procedure)

Densah Bur (Osseodensification)

Experimental

Implant sites in this arm will undergo osteotomy preparation using the osseodensification technique with Densah burs (Versah) running in a counter-clockwise direction (densifying mode) prior to implant placement.

Intervention: Densah Bur drilling (Procedure)

osteotome

Experimental

Implant sites in this arm will undergo osteotomy preparation using summers osteotome technique for lateral bone condensation and expansion prior to implant placement

Intervention: osteotome bone condensation (Procedure)

Outcomes

Primary Outcomes

Secondary Implant Stability using radio frequency analysis (RFA)

Time Frame: readings were taken 3 months post operative and 6 months after loading.

Implant stability measured using Resonance Frequency Analysis (RFA) via Osstell. Values recorded as ISQ (1-100) to evaluate osseointegration. where higher scores indicates higher stability

primary stability using Insertion Torque Value.

Time Frame: day of surgery

Evaluation of implant stability was done by measuring Insertion torque. Using the surgical contra-angled hand piece the initial torque value was set to10Ncm then increased sequentially by 5Ncm according to the torque required to place the implant at the desired depth. The final torque value used to drive the implant to its position was recorded as the peak insertion torque

Primary Implant Stability measured through Resonance Frequency Analysis (RFA)

Time Frame: the day of surgery

Implant stability will be measured using Resonance Frequency Analysis (RFA) via an Osstell device. The values are recorded as Implant Stability Quotient (ISQ) on a scale from 1 to 100, where higher scores indicate greater stability

Secondary Outcomes

  • Secondary Implant Stability using radio frequency analysis (RFA)(readings were taken 3 months post operative and 6 months after loading.)
  • Marginal Bone Loss (MBL)(cbct was done at implant placement and 3 months post operative and 6 months after loading.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Mahmoud

Principal Investigator

Future University in Egypt

Study Sites (1)

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