Evaluation of a Combined Ridge Expansion Technique With Simultaneous Dental Implant Placement

Alveolar Process Atrophy Clinical Trial

Official title:

Evaluation of a Combined Ridge Expansion Technique With Simultaneous Dental Implant Placement in Narrow Posterior Mandible

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05685576
• Other study ID #: UAlexandriaDentSurg22
• Status: Completed
• Phase: N/A
• Start date: March 25, 2022
• Est. completion date: March 5, 2023

Study information

• Verified date: May 2023
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with long span, narrow edentulous ridge in the posterior mandible underwent piezotomed ridge splitting and osseodensification with simultaneous implant placement.

Description:

This study is a single arm clinical trial. Patients of both genders, who are indicated for ridge splitting, were recruited from the outpatient clinic, Faculty of dentistry, Alexandria University. The PICO question: "What is the effect of piezotomed ridge splitting and osseodensification on implant placement in narrow posterior mandibular ridges?" Ethical approval for the study was obtained from the regional Ethical Review Board of the Faculty of Dentistry. All patients were informed about the procedure details, and each participant signed a written consent. Ridge expansion was accomplished by piezotomed ridge splitting and osseodensification. Simultaneous implant placement was done in the same procedure. Implant stability was assessed. Also, bone width gained and bone density were measured around the dental implants using cone beam computed tomography.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 5, 2023
• Est. primary completion date: March 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with good oral hygiene
• Patients with long-span, narrow posterior edentulous mandibular area
• Age limit range [25 - 66 years]
• Patients who accept to participate in the study
• Minimum height 10mm from the crest of the ridge till the upper border of inferior alveolar canal
• Minimum ridge thickness = 3mm at the crestal region
• If the patient is diabetic, should be controlled.

Exclusion Criteria:

• Immunosuppressive/ autoimmune disease patients
• Patients with osteoporosis
• Lack of sufficient amount of keratinizing mucosa at the crest of the edentulous saddle
• Patients with bleeding disorder disease
• Ridge width less than 3 mm
• Smokers
• Patients having periodontal disease
• The presence of a pathological lesion in the area of ridge splitting

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Alveolar Process Atrophy

Intervention

Device:
• Piezotomed ridge splitting and osseodensification
Ridge expansion using piezotomed ridge splitting and osseodensification

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Lydia Nabil

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The score of primary implant stability	- Primary stability of the implants is measured using: insertion torque and; resonance frequency analysis by Osstell ISQ device (Osstell ISQ, W&H, Sweden)	immediately at time of implant insertion
Secondary	The width of bone gained	Width of bone gained at the crest of the ridge is measured by cone beam computed tomography in mm	3 months postoperative
Secondary	The mean bone density around dental implants	The mean bone density around dental implants is measured by cone beam computed tomography in grey scale values	3 months postoperative