NCT07555509

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 9, 2026

Last Update Submit

April 24, 2026

Conditions

Implant Assesment

Outcome Measures

Primary Outcomes (1)

  • Bone density

    Assessed by 3D Cone Beam Computed Tomography

    Was assessed 3 times; *Baseline. * after 3 months. * after 6 months.

Secondary Outcomes (1)

  • Marginal bone height

    Was assessed 3 times; *Baseline. * after 3 months. * after 6 months.

Other Outcomes (1)

  • Implant stability

    assessed only once; *immediately postsurgical

Study Arms (2)

Osseodensification

EXPERIMENTAL
Procedure: Osseodensification

Conventional drilling

ACTIVE COMPARATOR
Procedure: Conventional drilling

Interventions

OsseodensificationPROCEDURE

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.

Osseodensification
Conventional drillingPROCEDURE

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

Conventional drilling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez Canal University

Ismailia, Ismalia, 41522, Egypt

Location

Related Publications (1)

  • [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

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 29, 2026

Study Start

January 1, 2024

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
More information

Locations

EG(1)