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

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).

Study Overview

• Status: Completed
• Conditions: Implant Assesment
• Intervention / Treatment: Procedure: Osseodensification; Procedure: Conventional drilling

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismalia
    • Ismailia, Ismalia, Egypt, 41522
      • Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osseodensification	Procedure: Osseodensification; 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.
Active Comparator: Conventional drilling	Procedure: Conventional drilling; Traditionally, implant osteotomies are prepared using conventional subtractive drilling, which removes bone to create space for implant insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone density	Assessed by 3D Cone Beam Computed Tomography	Was assessed 3 times; *Baseline. * after 3 months. * after 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal bone height	Assessed by 3D Cone Beam Computed Tomography	Was assessed 3 times; *Baseline. * after 3 months. * after 6 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability	Measured using resonance frequency analysis (ISQ)	assessed only once; *immediately postsurgical

Collaborators and Investigators

• Sponsor: Gulf Medical University

Publications and helpful links

General 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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): January 1, 2026
• Study Completion (Actual): February 1, 2026

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 302/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No