Osseodensification for Narrow Alveolar Ridge Expansion (OD-RridgeExp)

University of Science and Technology, Yemen

Status: Enrolling

Conditions: Bone Expansion; Osseodensification

Treatments: Procedure: Densah burs (Osseodensification Technique)

Study type: Interventional

Funder types: Other

Identifiers

NCT07436533

1446/0042/UREC/UST

Details and patient eligibility

About

This prospective clinical study aims to evaluate the effectiveness of osseodensification in expanding narrow alveolar ridges during dental implant site preparation. Alveolar ridge deficiency is a common clinical challenge that may complicate implant placement. Osseodensification is a minimally invasive drilling technique that preserves and compacts bone rather than removing it, potentially allowing simultaneous ridge expansion and implant placement.

In this study, patients presenting with narrow alveolar ridges indicated for dental implant placement will be treated using Densah burs operating in a non-extractive (densifying) mode. Ridge width will be measured directly using standardized Micro Castroviejo bone calipers at two reference levels: at the crestal bone level and at 5mm, at 10 mm apical to the crest. Measurements will be recorded immediately before and immediately after osseodensification.

The primary objective is to assess the dimensional changes in ridge width achieved through osseodensification without the use of additional ridge augmentation procedures. The study focuses solely on within-subject comparison (pre- and post-expansion measurements) and does not compare this technique to other ridge expansion methods.

The results are expected to provide clinical evidence regarding the amount of horizontal ridge expansion achievable using osseodensification and its applicability in managing narrow alveolar ridges for implant therapy.

Full description

This prospective clinical study follows a standardized protocol for alveolar ridge expansion using osseodensification. After local anesthesia and reflection of a full-thickness mucoperiosteal flap, the initial bone width is measured at the crest (0 mm) and 5 mm apical to the crest using Micro Castroviejo Bone Calipers.

The implant site preparation begins with a pilot drill, followed by the use of densifying burs (e.g., Densah Burs) in a counter-clockwise direction (non-subtractive mode) with copious irrigation. This technique allows for lateral condensation and expansion of the bone as the burs advance. After reaching the final desired diameter, the bone width is measured again at the same two levels (0 mm and 5 mm) to record the expansion gain.

Finally, the dental implant is placed, and primary stability is recorded using Insertion Torque . Post-operative care and follow-up follow standard dental implant protocols

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients aged 18 years or older, including both genders.
• Healed edentulous sites (short or long spans, single or multiple missing teeth) in maxillary or mandibular arches.
• At least 6 months post-extraction period (delayed implant placement).
• Alveolar ridge width of 3-5 mm at the crest (buccolingually).
• Low-density jaw regions (D1-D5 according to Misch classification).
• Presence of ≥ 2 mm trabecular bone core and trabecular-to-cortical bone ratio of ≥ 1:1.
• Sufficient vertical dimensions as assessed via CBCT.
• Straightforward cases according to SAC classification (Beagle, 2013).
• Well-motivated patients willing to attend follow-up visits and maintain good oral hygiene.

Exclusion criteria

• Acute or chronic infection or pathological condition at the proposed implant site.
• Severe buccal plate undercut or concavity.
• Signs of active infection in the implant zone.
• Severe parafunctional habits such as bruxism or clenching.
• Heavy smoking (more than 10 cigarettes per day).
• Inadequate inter-ridge distance or insufficient vertical height for implant placement.
• Use of medications compromising bone healing (e.g., corticosteroids, hormone replacement therapy, or bisphosphonates).
• Uncontrolled systemic diseases (e.g., diabetes, immunocompromised states, hyperparathyroidism, or fibrous dysplasia).
• History of radiotherapy to the head/neck or chemotherapy within the past 5 years.
• Current pregnancy during the surgical procedure.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

osseodensification Group

Experimental group

Description:

Participants with narrow alveolar ridges indicated for dental implant placement will undergo implant site preparation using the osseodensification technique. After flap elevation, baseline ridge width measurements will be obtained at the crestal level at 5mm and 10 mm apical to the crest using standardized Micro Castroviejo bone calipers. Osteotomy preparation will then be performed using Densah burs operating in densifying mode according to the manufacturer's recommended protocol. Following completion of osteotomy preparation and prior to implant insertion, ridge width measurements will be repeated at the same reference points. The primary evaluation consists of within-subject comparison of pre- and post-osseodensification ridge width measurements.

Treatment:

Procedure: Densah burs (Osseodensification Technique)