CClinicalTrials.gg
CompletedNCT07555509Updated Apr 29, 2026

Osseo-densification Versus Conventional Drilling for Dental Implant Placement

An interventional study of Osseodensification and Conventional drilling in Implant Assesment, sponsored by Gulf Medical University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Gulf Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Jan 2024, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

  • Implant Assesment
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In context

Lead sponsor

Gulf Medical University is the lead sponsor of 40 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Osseodensification

    Procedure: Osseodensification

  • Active comparator
    Conventional drilling

    Procedure: Conventional drilling

Interventions

  • ProcedureOsseodensification

    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.

  • ProcedureConventional drilling

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

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What researchers measure

Primary outcomes

  1. Bone density

    Assessed by 3D Cone Beam Computed Tomography

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

Secondary outcomes

  1. Marginal bone height

    Assessed by 3D Cone Beam Computed Tomography

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

Other outcomes

  1. Implant stability

    Measured using resonance frequency analysis (ISQ)

    Time frame: assessed only once; *immediately postsurgical

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Study locations

1 site
  • Suez Canal University
    Ismailia, Ismalia 41522, Egypt
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References and documents

Publications

  • [1] Canullo L, Del Fabbro M, Khijmatgar S, Panda S, Ravidà A, Tommasato G, et al. Dimensional and histomorphometric evaluation of biomaterials used for alveolar ridge preservation: a systematic review and network meta-analysis. Clin Oral Investig 2022; 26:141-58. [2] Jafarian M, Etebarian A. Reasons for Extraction of Permanent Teeth in General Dental Practices in Tehran, Iran. Medical Principles and Practice 2013; 22:239-44. [3] Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent 2003; 23:313-23. [4] Buser D, Martin W, Belser UC. Optimizing esthetics for implant restorations in the anterior maxilla: anatomic and surgical considerations. Int J Oral Maxillofac Implants 2004; 19:43-61. [5] Pjetursson BE, Thoma D, Jung R, Zwahlen M, Zembic A. A systematic review of the survival and complication rates of implant-supported fixed dental prostheses (FDPs) after a mean observation period of at least 5 years. Clin Oral Implants Res. 2012;23(Suppl 6):22-38. [6] Jung RE, Zembic A, Pjetursson BE, Zwahlen M, Thoma DS. Systematic review of the survival rate and the incidence of biological, technical, and esthetic complications of single crowns on implants. Clin Oral Implants Res. 2012;23(Suppl 6):2-21. [7] Molly L. Bone density and primary stability in implant therapy. Clin Oral Implants Res. 2006;17(Suppl 2):124-135. [8] Turkyilmaz I, McGlumphy EA. Influence of bone density on implant stability parameters and implant success: a retrospective clinical study. BMC Oral Health. 2008; 8:32. [9] 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;32(1):27-36. [10] Trisi P, Berardini M, Falco A, Podaliri Vulpiani M. New osseo-densificat

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07555509
Lead sponsor
Gulf Medical University
Responsible party
Sponsor
First posted
Apr 29, 2026
Start date
Jan 1, 2024
Primary completion
Jan 1, 2026
Completion
Feb 1, 2026
Last update
Apr 29, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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