An interventional study of Clockwise Cutting with Densah Burs and Counter-Clockwise Osseodensification with Densah Burs in Osseodensification Drilling Technique, sponsored by University of Science and Technology, Yemen. Active, not recruiting at 1 site in Yemen. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by University of Science and Technology, Yemen · Not applicable, Interventional, and Treatment
This study aims to compare the primary stability of dental implants placed using two different rotational modes of the Densah burs (Clockwise Cutting vs. Counter-Clockwise Osseodensification) under a fully guided protocol. The primary outcomes are peak insertion torque and immediate implant stability quotient (ISQ).
Achieving adequate primary stability in low-density bone remains a clinical challenge. Osseodensification (OD) has been introduced to preserve and compact bone during implant site preparation. Densah burs are unique as they can be operated in two rotational directions: clockwise (CW) for cutting and counter-clockwise (CCW) for densification. However, no randomized human study has directly compared these two modes using the same burs under a fully guided protocol. This study is a prospective, randomized, double-blind, split-mouth controlled clinical trial. Each participant will receive two implants at clinically comparable sites in the same jaw. One site will be prepared using CW cutting mode, and the paired site will be prepared using CCW osseodensification mode. Both interventions will be performed using the same Universal Densah burs, the same fully guided R2GATE surgical guide, and identical implant dimensions to isolate the effect of rotational direction.
The primary outcome is peak insertion torque (IT). Secondary outcomes include immediate implant stability quotient (ISQ) and the correlation between IT and ISQ within each preparation mode. This study will provide the first direct clinical evidence to guide clinicians in selecting the optimal rotational mode for implant site preparation.
University of Science and Technology, Yemen is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Counter-Clockwise Osseodensification with Densah Burs
Implant site preparation performed using Densah burs in clockwise cutting direction under a fully guided protocol
Procedure: Clockwise Cutting with Densah Burs
Osteotomy site preparation performed in a clockwise cutting direction using Densah burs following a fully guided protocol
Osteotomy site preparation performed in counter-clockwise direction using Densah burs following a fully guided protocol to achieve osseodensification
Peak Insertion Torque (IT)
Peak torque required to seat the implant at the planned final position, measured in N/CM using a calibrated surgical motor or a calibrated torque device.
Time frame: Immediately at implant placement (intraoperative).
Immediate Implant Stability Quotient (ISQ)
Arithmetic mean of mesial, distal, buccal, and lingual resonance frequency reading measured using the Osstell device. ISQ ranges from 1 to 100, with higher values indicating greater stability.
Time frame: Immediately after implant placement (intraoperative).
Correlation between Insertion Torque and Immediate ISQ.
Pearson or Spearman correlation coefficient between insertion torque (N/cm) and mean ISQ within each rotational mode.
Time frame: Immediately after implant placement (intraoperative).
Plan to share: No — Individual participant data will not be shared to protect patient confidentiality and privacy, as the dataset contains sensitive clinical information and specific implant coordinates.
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Oct 2026, 9 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University of Science and Technology, Yemen