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

NCT07378020 | Completed DMC

• 1 other identifier: FUE.REC (25)/7-2023
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Bone Density

Keywords

Osseodensification

Outcome Measures

Primary Outcomes (2)

• primary stability using Insertion Torque Value.

  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

  day of surgery

• Primary Implant Stability measured through Resonance Frequency Analysis (RFA)

  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

  the day of surgery

Secondary Outcomes (2)

• 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.

Study Arms (3)

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

Procedure: Conventional Osteotomy

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.

Procedure: Densah Bur drilling

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

Procedure: osteotome bone condensation

Interventions

Conventional Osteotomy PROCEDURE

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

Also known as: Subtractive Drilling, Standard Drilling

Conventional Drilling

Densah Bur drilling PROCEDURE

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

Also known as: Osseodensification, Non-subtractive Drilling

Densah Bur (Osseodensification)

osteotome bone condensation PROCEDURE

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.

Also known as: Manual Bone Condensation, Osteotome Expansion

osteotome

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Oral and Maxillofacial Department Future Dental Hospital

Cairo, Fifth Settlement, 11835, Egypt

Location

Related Publications (4)

• Elsheikh HA, Gadallah AT, Kandil I. Impact of Three Different Surgical Drilling Protocols on Early Loaded Single Implant in Posterior Maxilla: A 3-year Follow-up. J Contemp Dent Pract. 2022 Aug 1;23(8):819-827.

  BACKGROUND

• Evrenk O, et al. Evaluation of implant primary stability using different drilling protocols: an in vitro study. BMC Oral Health. 2025 Aug 9. doi: 10.1186/s12903-025-06661-4.

  BACKGROUND

• Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36.

  BACKGROUND

• Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compend Contin Educ Dent. 1994 Feb;15(2):152, 154-6, 158 passim.

  BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• dr lobna abdelaziz aly, PhD

  Future University in Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A randomization sequence was generated using a web-based service (Randomization.com) employing block randomization. To ensure allocation concealment, a research coordinator (who was not involved in the clinical procedures) prepared sequentially numbered, opaque, sealed envelopes corresponding to the total number of implants required for the study. At the time of surgery, a research colleague opened the next sequential envelope for each implant site to determine the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 30, 2026
• Study Start: January 5, 2024
• Primary Completion: January 5, 2025
• Study Completion: December 15, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)