Osseodensification for Narrow Alveolar Ridge Expansion (OD-RridgeExp)

August 7, 2026 updated by: Essamali Alsaidi, University of Science and Technology, Yemen

Expansion of Narrow Alveolar Ridges Using Osseodensification Burs for Dental Implant Placement: A Prospective Single-Arm Interventional Clinical Study

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Essam Ali AL-saidi, BDS
  • Phone Number: 00967 770982890 - 00967 771699
  • Email: asdentme@gmail.com

Study Contact Backup

  • Name: Abdalwahab Yahya Aldailami, PhD
  • Phone Number: 00967 777781033

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 informed consent 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:

  • 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 clinically significant 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 corticosteroid 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 informed consent or attend the required follow-up visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
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.
Other Names:
  • Densah burs
  • Densifying osteotomy preparation
  • Osseodensification-Assisted Implant-Site Preparation
  • Non-subtractive drilling protocol
  • Osseodensification drilling technique

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Alveolar Ridge Width Following Osseodensification
Time Frame: Intraoperative assessment: immediately before and immediately after osseodensification during the same surgical procedure

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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Insertion Torque at Dental Implant Placement
Time Frame: Intraoperative assessment at the time of 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.
Intraoperative assessment at the time of implant placement.
Occurrence of Postoperative Clinical Complications
Time Frame: From the surgical procedure through the 12-week postoperative follow-up period.
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.
From the surgical procedure through the 12-week postoperative follow-up period.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Agreement Between Baseline CBCT and Direct Clinical Caliper Measurements
Time Frame: Preoperative CBCT assessment and intraoperative baseline measurement before osseodensification.

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.
Preoperative CBCT assessment and intraoperative baseline measurement before osseodensification.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Science and Technology, Yemen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1446/0042/UREC/UST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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