Clinical trial NCT04609475: Osseodensification Versus Motor-Driven Expanders' Techniques for Increasing Bone Density With Simultaneous Implant Placement
Official title: Osseodensification Versus Motor-Driven Expanders' Techniques for Increasing Bone Density With Simultaneous Implant Placement (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Loss
Keywords: Endosseous implants
Osseodensification
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2020-10-30
Enrollment: 14
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare and measure the amount of bone density and ridge width gained with motor driven expanders and densifying burs with simultaneous dental implant placement.

Detailed description: Seven patients were treated by the osseodensification technique and another seven were treated by the motor-driven expanders' technique with simultaneous implant placement.

Eligibility criteria: Inclusion Criteria:

* Patients requiring implant placement in the anterior maxilla until the premolar region.
* Patients are medically fit.
* The width of the deficient maxillary alveolar ridge not less than 3mm.
* Patients willing and fully capable to comply with the study protocol.

Exclusion Criteria:

* Atrophic ridge (2 mm or less) with no interposition of cancellous bone between the buccal and palatal plates.
* Uncontrolled metabolic disease (e.g. uncontrolled diabetes).
* Heavy smokers (\>15 cigarettes/day).
* Acute oral infections.
* Untreated periodontal disease.
* Poor oral hygiene.
* Pregnant or breastfeeding patient.
* A history of radiotherapy to the head and neck region or treatment with bisphosphonates.
* Female patients using oral contraceptive pills.
* Presence of oral parafunctional habits.
* Surgical site needs to be grafted.

Primary outcomes:
measure: Post-operative pain
timeFrame: up to 1 month
measure: Implant stability
timeFrame: up to 6 months
measure: Bone density
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Shaimaa A Abdou, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Magued H Fahmy, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Ahmed O Sweedan, PhD
role: STUDY_DIRECTOR
References:
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citation: Jimbo R, Tovar N, Marin C, Teixeira HS, Anchieta RB, Silveira LM, Janal MN, Shibli JA, Coelho PG. The impact of a modified cutting flute implant design on osseointegration. Int J Oral Maxillofac Surg. 2014 Jul;43(7):883-8. doi: 10.1016/j.ijom.2014.01.016. Epub 2014 Feb 28.
citation: Johnson C. Measuring Pain. Visual Analog Scale Versus Numeric Pain Scale: What is the Difference? J Chiropr Med. 2005 Winter;4(1):43-4. doi: 10.1016/S0899-3467(07)60112-8.