OsseodensificationOD-RridgeExpNCT07436533
Osseodensification for Narrow Alveolar Ridge Expansion
A study testing Densah burs (Osseodensification Technique) in people with Osseodensification and Bone Expansion, run by University of Science and Technology, Yemen at 1 site in Yemen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osseodensification, Bone Expansion, Alveolar Bone Loss
- What is being tested?
- Densah burs (Osseodensification Technique)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteYemen
- Study dates
- 1 Feb 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Yemen1 site
60 Meters St., Madbah, University of Science and Technology
Sanaa, S, (15201 - 13064)
About this study
Official title: 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
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.
- Being tested
- Densah burs (Osseodensification Technique)
- Keywords
- osseodensification, Dental implants, Implant-site preparation, Insertion torque, Narrow alveolar ridge, Alveolar ridge expansion, Micro Castroviejo bone caliper
- Medical subject headings
- Alveolar Bone Loss, Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Densah burs (Osseodensification Technique)Procedure or surgery
Also called Osseodensification-Assisted Implant-Site Preparation, Densah burs, Densifying osteotomy preparation, Non-subtractive drilling protocol
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.
| Study group | Role | What they receive |
|---|---|---|
| osseodensification Group | Experimental | 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. Receives: Procedure: Densah burs (Osseodensification Technique) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative assessment: immediately before and immediately after osseodensification during the same surgical procedure
Secondary outcomes (2)
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.
Measured: Intraoperative assessment at the time of implant placement.
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.
Measured: From the surgical procedure through the 12-week postoperative follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Feb 2025
- Primary completion1 Mar 2026
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsseodensificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study used a prospective, single-arm, non-randomized interventional design. All enrolled participants underwent dental implant-site preparation using the osseodensification technique. No conventional-drilling or alternative ridge-expansion comparison group was included. Alveolar ridge width was measured within the same implant site immediately before and immediately after osseodensification-assisted osteotomy preparation. Measurements were obtained at the crestal level and at 5 mm and 10 mm apical to the crest. Multiple implant sites were permitted within the same participant.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Science and Technology, Yemen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Essamali Alsaidi, University of Science and Technology, Yemen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436533
- Sponsor's protocol ID
- 1446/0042/UREC/UST
- Acronym
- OD-RridgeExp
- Status last verified
- Aug 2026
- First submitted
- 21 Feb 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expansion of Narrow Alveolar Ridges Using Osseodensification Burs for Dental Implant Placement: A Prospective Single-Arm Interventional Clinical Study
- ClinicalTrials.gov ID
- NCT07436533
- Acronym / sponsor ID
- OD-RridgeExp / 1446/0042/UREC/UST
- Keywords
- osseodensification, Dental implants, Implant-site preparation, Insertion torque, Narrow alveolar ridge, Alveolar ridge expansion, Micro Castroviejo bone caliper
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Science and Technology, YemenUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study used a prospective, single-arm, non-randomized interventional design. All enrolled participants underwent dental implant-site preparation using the osseodensification technique. No conventional-drilling or alternative ridge-expansion comparison group was included. Alveolar ridge width was measured within the same implant site immediately before and immediately after osseodensification-assisted osteotomy preparation. Measurements were obtained at the crestal level and at 5 mm and 10 mm apical to the crest. Multiple implant sites were permitted within the same participant.
| Arm | Type | Receives |
|---|---|---|
| osseodensification Group | Experimental | Procedure: Densah burs (Osseodensification Technique)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Densah burs (Osseodensification Technique)Also: Osseodensification-Assisted Implant-Site Preparation, Densah burs, Densifying osteotomy preparation, Non-subtractive drilling protocolDental 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. | Procedure or surgery | osseodensification Group |
Primary outcome
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.
2 secondary outcomes
Insertion Torque at Dental Implant Placement
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Implant Osseointegration, Implant Osteotomy
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Two-Stage Transcrestal Sinus Lift With Osseodensification: Allograft vs Autogenous-Xenograft
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Implant Stability Outcomes Following Immediate Implant Placement Using Osseodensification Versus Conventional Drilling
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Clinical, Radiographic, Histological, and Patient-reported/ Experience Outcome Measures of Endoscopically-monitored Graftless Transcrestal Sinus Floor Elevation With Simultaneous Multiple Implant Placement Using Osseodensification(OD) Versus Osteotomes (OT) in Subsinus Bone Height of 4-5 mm: An RCT
Osseodensification Drilling Technique
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Densah burs (Osseodensification Technique) in people with Osseodensification and Bone Expansion, run by University of Science and Technology, Yemen at 1 site in Yemen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Yemen. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alveolar Ridge Width Following Osseodensification (time frame: Intraoperative assessment: immediately before and immediately after osseodensification during the same surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.