OSSEODENSIFICATION BY DENSAH BURS IN COMBINATION WITH ACTIVATED PLASMA ALBUMIN GEL FOR TRANSCRESTAL MAXILLARY SINUS LIFTING WITH SIMULTANEOUS IMPLANT PLACEMENT (CLINICAL TRIAL)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Postoperative pain
Study Overview
Brief Summary
Aim of the current study is to evaluate clinically and radiographically transcrestal sinus lifting with densah burs with the use of activated plasma albumin gel associated with simultaneous implant placement.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient with missing maxillary premolars and molars.
- •Vertical bone height of 3-5 mm.
- •Good oral hygiene.
- •Non smokers.
Exclusion Criteria
- •Bad oral hygiene.
- •Presence of infection or periapical lesions in adjacent teeth.
- •Acute maxillary sinusitis.
- •Bruxism or clenching.
- •Medically compromised patients with a condition that affects the procedure (patients with bone diseases such as osteogenesis imperfecta and polyarthritis and patients on radiotherapy and chemotherapy)
Arms & Interventions
Sinus lifting using densah bur in combination with activated plasma albumin gel
Intervention: Densah bur in combination with activated plasma albumin gel (Combination Product)
Outcomes
Primary Outcomes
Postoperative pain
Time Frame: up to one week
This will be assessed using a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Implant stability
Time Frame: up to 6 months
Resonance frequency analysis is based on determining whether or not an implant is stable enough. The result is presented as an ISQ value of 1-100. The higher the ISQ, the more stable the implant.
Vertical bone height gain
Time Frame: up to 6 months
To determine the amount of bone height gain, cone beam computed tomography (CBCT) scans will be taken immediately and after 6 months. Amount of bone height gain will be measured linearly in millimeter by determine the difference between residual bone height and bone height above the implant immediately and 6 months postoperatively in anteroposterior and mediolateral dimensions.
Bone density around implant
Time Frame: up to 6 months
This will be measured from CBCT scans in grayscale using a software. Densitometric analysis will be performed around dental implants on CBCT image using the software supplied with the machine. This analysis gives the actual bone density around the immersed dental implant that proves the process of osseointegration. Higher values indicate better results
Secondary Outcomes
No secondary outcomes reported
Investigators
Esraa Salem Kamal
Oral and Maxillofacial Surgery MSc Candidate
Alexandria University