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Completed

NCT Number: NCT07555509

Osseo-densification Versus Conventional Drilling for Dental Implant Placement

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).

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Key information

Conditions

Implant Assesment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University

Ismailia, Ismalia, 41522, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Osseodensification

Procedure

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.

Conventional drilling

Procedure

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

Primary outcomes

  1. Bone density

    Time frame: Was assessed 3 times; *Baseline. * after 3 months. * after 6 months.

    Assessed by 3D Cone Beam Computed Tomography

Secondary outcomes

  1. Marginal bone height

    Time frame: Was assessed 3 times; *Baseline. * after 3 months. * after 6 months.

    Assessed by 3D Cone Beam Computed Tomography

Other outcomes

  1. Implant stability

    Time frame: assessed only once; *immediately postsurgical

    Measured using resonance frequency analysis (ISQ)

Sponsors and collaborators

Lead sponsor

Gulf Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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