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NCT Number: NCT07436533

Osseodensification for Narrow Alveolar Ridge Expansion

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

60 Meters St., Madbah, University of Science and Technology

Sanaa, S, (15201 - 13064), Yemen

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Densah burs (Osseodensification Technique)

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Science and Technology, Yemen

Other

Registry information

Official study title

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

Acronym: OD-RridgeExp

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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