ClinicalTrials.gg
Active, not recruitingNCT07436533OD-RridgeExpUpdated Aug 11, 2026

Osseodensification for Narrow Alveolar Ridge Expansion

An interventional study of Densah burs (Osseodensification Technique) in Osseodensification, Bone Expansion and Alveolar Bone Loss, sponsored by University of Science and Technology, Yemen. Active, not recruiting at 1 site in Yemen. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by University of Science and Technology, Yemen · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Feb 2025, registered Feb 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This prospective, single-arm, non-randomized interventional clinical study was designed to evaluate the immediate horizontal dimensional change in narrow alveolar ridges following osseodensification-assisted dental implant-site preparation.

Eligible participants with healed edentulous sites in the maxilla or mandible underwent implant-site preparation using osseodensification burs operated in densifying mode. Alveolar ridge width was measured directly using standardized Micro Castroviejo bone calipers at three predefined levels: the crestal level and 5 mm and 10 mm apical to the crest. Measurements were obtained immediately before and immediately after osseodensification-assisted osteotomy preparation.

The primary outcome was the within-site change in alveolar ridge width at the three measurement levels. Additional assessments included insertion torque at implant placement and recorded postoperative complications. The study included a single treatment group and did not include a conventional-drilling or alternative ridge-expansion comparison group

Read the detailed description

This study used a prospective, single-arm, non-randomized interventional design to assess immediate alveolar ridge-width changes following osseodensification-assisted implant-site preparation.

Eligible adult participants had healed edentulous sites requiring dental implant placement and presented with limited horizontal alveolar ridge width. Implant sites were located in either the maxilla or mandible and included anterior and posterior regions.

Preoperative CBCT examination was performed for implant planning and assessment of ridge dimensions. During surgery, local anesthesia was administered and a full-thickness mucoperiosteal flap was reflected. Baseline ridge width was measured directly using standardized Micro Castroviejo bone calipers at the crestal level and at 5 mm and 10 mm apical to the crest.

Implant-site preparation began with a pilot drill, followed by sequential osseodensification burs operated in counterclockwise densifying mode under copious irrigation. After completion of the osteotomy and before implant insertion, ridge-width measurements were repeated at the same predefined reference levels.

The primary assessment was the within-site difference between the post-osseodensification and baseline clinical measurements at each level. Dental implants were subsequently placed, and primary mechanical stability was assessed using insertion torque. Postoperative events were recorded during the scheduled follow-up period.

Some participants contributed more than one implant site. Enrollment therefore refers to the number of participants, whereas ridge-width and implant-related measurements were recorded at the implant-site level.

02

Conditions studied

  • Osseodensification
  • Bone Expansion
  • Alveolar Bone Loss
  • Jaw, Edentulous, Partially

Keywords

  • osseodensification
  • Dental implants
  • Implant-site preparation
  • Insertion torque
  • Narrow alveolar ridge
  • Alveolar ridge expansion
  • Micro Castroviejo bone caliper
03

In context

Alveolar Bone Loss

318 studies on the registry are indexed under Alveolar Bone Loss; 79 are open to participants now.

This study's enrollment of 35 is above the median of 25 across 269 interventional studies indexed under Alveolar Bone Loss.

Browse Alveolar Bone Loss studies →

Lead sponsor

University of Science and Technology, Yemen is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18 years or older and within the upper age limit specified in the final ethics-approved protocol.
  • Healed edentulous sites involving single or multiple missing teeth in the maxillary or mandibular arches.
  • A post-extraction healing period of at least 6 months before implant placement.
  • Adequate vertical bone dimensions for dental implant placement, as assessed using CBCT.
  • Absence of active local infection or pathological lesions at the proposed implant site.
  • Clinical suitability for dental implant placement and osseodensification-assisted osteotomy preparation.
  • Ability and willingness to provide and attend the scheduled follow-up visits.
  • Maintenance of acceptable oral hygiene.
  • Alveolar ridge width of ≤8 mm at the crestal level, measured buccolingually, and considered to require horizontal expansion during implant-site preparation.
  • Implant sites classified as Misch D1-D4 according to the protocol-specified bone-quality assessment.

Exclusion criteria

Exclusion Criteria:

  • Acute or chronic infection or a pathological condition at the proposed implant site.
  • Severe buccal plate undercut or ridge concavity that precluded safe implant-site preparation.
  • Insufficient vertical bone height for the planned dental implant.
  • Inadequate interarch distance for implant-supported rehabilitation.
  • Severe parafunctional habits, including bruxism or clenching.
  • Heavy smoking, defined as more than 10 cigarettes per day.
  • Use of medications considered likely to compromise bone healing according to the approved protocol, including relevant or antiresorptive therapy.
  • Uncontrolled systemic disease or a medical condition that could materially affect surgical healing or implant treatment.
  • History of radiotherapy to the head and neck or chemotherapy within the preceding 5 years.
  • Current pregnancy at the time of the surgical procedure.
  • Inability or unwillingness to provide or attend the required follow-up visits
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

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05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    osseodensification Group

    Participants with healed edentulous sites and limited horizontal alveolar ridge width underwent dental implant-site preparation using the osseodensification technique. Baseline ridge-width measurements were obtained using standardized Micro Castroviejo bone calipers at the crestal level and at 5 mm and 10 mm apical to the crest. Following osseodensification-assisted osteotomy preparation, ridge-width measurements were repeated at the same reference levels before implant insertion.

    Procedure: Densah burs (Osseodensification Technique)

Interventions

  • ProcedureDensah burs (Osseodensification Technique)

    Dental implant osteotomies were prepared using sequential osseodensification burs operated in counterclockwise densifying mode under copious irrigation. The burs were advanced using a controlled pumping motion according to the study protocol. Ridge width was measured immediately before and after completion of the osteotomy at three predefined levels, followed by dental implant placement and insertion-torque recording.

    Also known as: Osseodensification-Assisted Implant-Site Preparation, Densah burs, Densifying osteotomy preparation, Non-subtractive drilling protocol, Osseodensification drilling technique

06

What researchers measure

Primary outcomes

  1. Change in Alveolar Ridge Width Following Osseodensification

    Change in alveolar ridge width, measured in millimeters, using standardized Micro Castroviejo bone calipers at three predefined reference levels: (1) the crestal bone level, (2) 5 mm apical to the crest, and (3) 10 mm apical to the crest. Measurements were obtained immediately before osteotomy preparation and immediately after completion of osseodensification-assisted osteotomy preparation, before implant insertion. The outcome was calculated separately at each level as the post-osseodensification measurement minus the corresponding baseline measurement.

    Time frame: Intraoperative assessment: immediately before and immediately after osseodensification during the same surgical procedure

Secondary outcomes

  1. Insertion Torque at Dental Implant Placement

    Primary mechanical implant stability was assessed by recording the maximum insertion torque, measured in Newton-centimeters (Ncm), at the time of dental implant placement following osseodensification-assisted osteotomy preparation.

    Time frame: Intraoperative assessment at the time of implant placement.

  2. Occurrence of Postoperative Clinical Complications

    The occurrence of recorded postoperative clinical events was assessed after implant placement. Events included pain, edema, infection, paresthesia, supuration, and other clinically documented complications. Each event was recorded using the prespecified study definitions and reported using the number of participants and implant sites with available follow-up data.

    Time frame: From the surgical procedure through the 12-week postoperative follow-up period.

Other outcomes

  1. Agreement Between Baseline CBCT and Direct Clinical Caliper Measurements

    Agreement between preoperative CBCT-derived alveolar ridge-width measurements and direct intraoperative baseline measurements obtained using Micro Castroviejo bone calipers was assessed at the crestal level and at 5 mm and 10 mm apical to the crest. The comparison included paired differences, rank correlations, and descriptive Bland-Altman limits of agreement. The analysis assessed baseline measurement correspondence and did not compare postoperative caliper measurements with postoperative CBCT.

    Time frame: Preoperative CBCT assessment and intraoperative baseline measurement before osseodensification.

07

Study locations

1 site
  • 60 Meters St., Madbah, University of Science and Technology
    Sanaa, S (15201 - 13064), Yemen
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07436533
Lead sponsor
University of Science and Technology, Yemen
Responsible party
Essamali Alsaidi (Master's Degree Candidate, F aculty of Dentistry, University of Science and Technology, Yemen) — Principal investigator
First posted
Feb 27, 2026
Start date
Feb 1, 2025
Primary completion
Mar 1, 2026
Completion
Sep 1, 2026 (estimated)
Last update
Aug 11, 2026

Oversight

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

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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