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Efficiency of Using Osseodensification Protocol

Efficiency of Using Osseodensification Protocol for Alveolar Ridge Expansion in Edentulous Alveolar Ridges

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06426719
Enrollment
18
Registered
2024-05-23
Start date
2022-05-15
Completion date
2024-02-15
Last updated
2024-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Resorption

Keywords

Densah burs, Osseodensification, OsseoHand Osteotomes, alveolar ridge wideninig

Brief summary

the goal of this clinical trial is to learn if the new osseo-densification technique works to provide enough bone width and quality prior to implant placement in the upper jaw the main question it aims to answer is: Is the use of osseo-densification protocol better than the standard alveolar ridge widening techniques; regarding efficiency and comfort in obtaining sufficient alveolar ridge width in horizontally atrophic alveolar ridges?

Detailed description

a new osseo-densification protocol using specially designed Densah burs was compared to conventional hand Osteotome technique to test its efficiency in providing sufficient bone quantity and quality in cases of horizontally deficient maxillary edentulous alveolar ridge sites that require expansion prior to dental implant placement

Interventions

PROCEDUREAlveolar ridge wideninig via applying osseodensification protocol using densah burs

alveolar ridge expansion using densah burs in horizontally deficient maxillary alveolar ridges prior to dental implants insertion

PROCEDUREAlveolar ridge widening via hand osteotomes

Alveolar ridge expansion using hand driven osteotomes in horizontally deficient maxillary alveolar ridges prior to dental Implant insertion

Sponsors

Cairo University
CollaboratorOTHER
Mohamed Magdy Mostafa Shehata
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

a new technique used to provide sufficient alveolar ridge width and enhance bone quality at horizontally deficient maxillary alveolar ridges prior to implant placement. the new technique uses specially designed burs called Densah burs that act by causeing bone compaction rather than bone removing from the osteotomy site

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age ≥18 years old. * In cases of an initial ridge width ≤ 5mm that contains ≤ 2mm of trabecular bone core. * Alveolar ridges with narrow crest and wider base.

Exclusion criteria

* Uncontrolled diabetic patients * Heavy Smokers * Patients suffering from osteoporosis * Patients receiving chemo or radio therapy * Patients suffering from bleeding disorders * Patients suffering from intraosseous lesions at the proposed site of implant * Patients with insufficient alveolar bone hight less than 10 mm. * Resorbed ridge with a narrow base.

Design outcomes

Primary

MeasureTime frameDescription
efficiency of ridge widening techniqueintraoperative and within 3 days post operativethe amount of ridge width gain is measured both clinically via a caliber and radiographically on CBCT

Secondary

MeasureTime frameDescription
primary stability of implantintra-operative after dental implant placementthe primary stability of the inserted dental implant is measured via osstell device
length of surgical procedureDuring surgerythe time required for completion of the surgical procedure is measured in minutes using stop watch
Value of painImmediate post operativethe degree of pain or discomfort examined by the patient during the ridge widening procedure is recorded using a visual scale where 0 represents no pain while 1 minimum pain and 10 is maximum pain

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026