CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
crestal sinus approach technique +1 moreprocedure
Likely dose
Not stated in record
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Search/NCT04309682
NCT04309682N/ACompleted

Clinical and Radiographic Evaluation of Implants Placed Without Bone Grafts in Two Different Sinus Floor Elevation Techniques. A Randomized Controlled Clinical Trial

Misr International University·interventional·Posted Mar 16, 2020·Updated Aug 26, 2024

In Brief

A clinical study evaluating crestal sinus approach technique and Lateral sinus approach for Dental Implant Placement. Completed, enrolled 22 participants across 1 site.

Detailed Summary

Statement of the problem: Vertical bone height reduction after extraction in the posterior maxilla complicates the treatment plan. Lateral sinus elevation, crestal sinus elevation, using short implants and different grafting procedures are some of the proposed treatment protocols, however, there is still a gap of knowledge in high quality evidence for the most effective approach. Purpose : The aim of the study is to evaluate clinical long term implant stability and radiographic vertical bone height gain after implant placement in posterior maxilla using crestal sinus approach in comparison to lateral sinus elevation technique. Materials and Methods: Thirty patients have single maxillary posterior tooth in atrophic maxilla will be enrolled. Patients will be allocated randomly into two groups; group 1 (test group) will receive implants using crestal sinus approach and group 2 (control group) will be assigned to the lateral sinus elevation technique, no bone grafts will be placed in both groups. Resonance frequency analysis will be employed to measure implant stability with a dedicated device (Osstell). For each implant, implant stability quotient ISQ values will be measured from the four sites.The mean of all measurements will be rounded to a whole number and regarded as the final ISQ of the implant. ISQ values will be obtained after implant insertion, at 3 months after delivery of the final restoration, at 6 and 12 months post-surgical. CBCT will be taken at 3 \&12 months follow up periods, to assess the amount of bone height gained around the dental implants in both groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 16, 2020
Enrollment StartDec 1, 2021
Primary CompletionJul 1, 2024
Study CompletionAug 21, 2024
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.3 years ago

Interventions

crestal sinus approach techniqueprocedure

a Full thickness flap will be elevated at the edentulous site with two vertical releasing incision and then the preparation of osteotomy will be prepared following standard implant system protocol preparation of the osteotomy. Drilling will be done gently till reaching 0-1mm from the sinus floor, then implant placement will take place and the implant itself will be used to gently elevate the sinus up to 3-5mm.

Lateral sinus approachprocedure

a full-thickness flap will be elevated at the edentulous site with two vertical releasing incisions extending to the vestibule for better reflection and exposure to the lateral wall of the sinus. The lateral antrostomy will be prepared in the lateral sinus wall using rotary bur no. 8 to provide adequate access to remove the thin to thick cortical bone and to expose the thin sinus membrane. The membrane will be elevated across the sinus floor and up the medial wall and this elevation must extend anteriorly-posteriorly to provide the exposed sinus floor. Drilling will be done gently till reaching 0-1mm from the sinus floor, then implant placement will take place