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Osseo-densification Versus Conventional Drilling for Dental Implant Placement

Osseo-densification Versus Conventional Drilling for Dental Implant Placement: A Double-Blinded Randomized Split-Mouth Clinical Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07555509
Enrollment
16
Registered
2026-04-29
Start date
2024-01-01
Completion date
2026-02-01
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implant Assesment

Brief summary

Primary implant stability and bone preservation are critical determinants of successful osseointegration, particularly in sites with low bone density. Conventional drilling removes bone and may reduce stability, whereas osseo-densification is a non-subtractive technique that compacts bone to enhance its density and strength. Objective: To compare osseo-densification and conventional drilling techniques in terms of implant primary stability, peri-implant bone density, and marginal bone loss during early healing. Methods: A double-blinded, randomized split-mouth clinical trial was conducted on eight participants requiring bilateral maxillary implants (n = 16 sites). Each patient received one implant using the osseo-densification technique (Densah burs, counterclockwise mode) and one using conventional sequential drilling. Cone-beam computed tomography (CBCT) was used to evaluate bone density and marginal bone levels at baseline, three, and six-months post-placement. Implant stability was measured immediately after insertion using resonance frequency analysis (Osstell ISQ). Data were analysed using t-tests and repeated-measures ANOVA (p \< 0.05).

Interventions

osseo-densification is a recently introduced, non-subtractive drilling technique that utilizes specially designed densifying burs in a counterclockwise (densifying) mode to laterally compact and autograft bone along the osteotomy walls.\[9\] This compaction of trabecular bone increases bone density, enhances primary stability, and may improve long-term bone-to-implant contact.

Traditionally, implant osteotomies are prepared using conventional subtractive drilling, which removes bone to create space for implant insertion.

Sponsors

Gulf Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* • Systemically and medically healthy adults (\>18 years old) of either sex. * Presence of a single missing tooth in the anterior or posterior maxilla with a minimum alveolar bone width of 6 mm, indicated for delayed implant placement. * Bone quality corresponding to D3-D4 density as determined by cone-beam computed tomography (CBCT). * Adequate keratinized mucosa of at least 3 mm in width (measured from the gingival margin to the mucogingival junction). * Intact buccal periodontal tissues, including bone, soft tissue, and ligament integrity. * Good oral hygiene and compliance with follow-up visits.

Exclusion criteria

* • Systemic medical conditions that could compromise surgical healing or osseointegration (e.g., uncontrolled diabetes mellitus). * Regular use of medications known to interfere with bone metabolism or healing, such as anticoagulants, antiplatelet agents, or systemic glucocorticoids. * Pregnancy or lactation in female participants. * Heavy smoking habits (\>10 cigarettes per day), alcohol abuse, or recreational drug use. * Current or previous history of periodontal disease affecting adjacent teeth. * Active periodontal or periapical infection at the intended implant site.

Design outcomes

Primary

MeasureTime frameDescription
Bone densityWas assessed 3 times; *Baseline. * after 3 months. * after 6 months.Assessed by 3D Cone Beam Computed Tomography

Secondary

MeasureTime frameDescription
Marginal bone heightWas assessed 3 times; *Baseline. * after 3 months. * after 6 months.Assessed by 3D Cone Beam Computed Tomography

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026