Efficiency of Using Osseodensification Protocol

Not Applicable

Completed

• Conditions: Alveolar Bone Resorption
• Interventions: Procedure: Alveolar ridge wideninig via applying osseodensification protocol using densah burs; Procedure: Alveolar ridge widening via hand osteotomes

• Registration Number: NCT06426719
• Lead Sponsor: Mohamed Magdy Mostafa Shehata

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

Study Timeline

• Study Start: 2022-05-15
• Primary Completion: 2024-01-20
• Study Completion: 2024-02-15
• Status Verified: 2024-05
• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-05-18
• Last Update Submitted: 2024-05-18
• Study First Posted: 2024-05-23
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group osseodensification	Alveolar ridge wideninig via applying osseodensification protocol using densah burs	the group in which alveloalr ridge widening is done using densah burs, it is the study group
conventional osteotome group	Alveolar ridge widening via hand osteotomes	the group in which alveolar ridge expansion is done using hand driven osteotomes . it is the conventional froup

Primary Outcome Measures

Name	Time	Method
efficiency of ridge widening technique	intraoperative and within 3 days post operative	the amount of ridge width gain is measured both clinically via a caliber and radiographically on CBCT

Secondary Outcome Measures

Name	Time	Method
length of surgical procedure	During surgery	the time required for completion of the surgical procedure is measured in minutes using stop watch
Value of pain	Immediate post operative	the 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
primary stability of implant	intra-operative after dental implant placement	the primary stability of the inserted dental implant is measured via osstell device

Trial Locations

Locations (1)

Mohamed Magdy Mostafa shehata; 🇪🇬 Cairo, Egypt