International Dental Continuing Education (IDCE) centre
Cairo, Egypt
NCT Number: NCT04309682
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.
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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Cairo, Egypt
After administration of local anesthesia, the allocation will be revealed, for the test group, 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. For the control group, 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. Primary stability of the implant will be measured by rotational insertion torque value, to be ≥30Ncm(25). A resorbable collagen membrane will be placed over the window preparation in the lateral approach to prevent the flap tissue in cooperating inside the antrostomy and the osseointegration process. Primary closure of the flap will be achieved.
After 3 months of the implant placement, stage II will be performed, 2 weeks later, impressions will be taken as regular for the prosthetic crowns fabrication. All crowns will be temporary cemented to allow an easy access to the implant platform for the follow-up RFA measurements.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
1 Patients who have at least one missing posterior maxillary tooth. 2. Adults above the age of 18. 3. Bone height from 4mm to 6mm under the maxillary sinus assessed in CBCT. 4. Good oral hygiene. 5. Patient accepts to sign an informed consent.
Exclusion criteria
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.
Other names: zimmer biomed dental implants and crestal sinus approach
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
Other names: Zimmer biomed dental implants and lateral sinus approach
Time frame: 3 - 6 - 12 months
Implant stability will be measured using Osstell to assess any changes in the implant stability over time and changes from baseline
Time frame: 3 - 12 months
Measured by CBCT
Time frame: for 10 days after the surgery
Measured using Visual Analogue Scale (VAS) The patients will mark the pain perception in a non-numerical 100 mm line ranging from "no pain=0" (left) to "very painful=100" (right).
Time frame: 12 months
Measured using Visual Analogue Scale (VAS) The patients will mark their satisfaction in a non-numerical 100 mm line ranging from "not at all satisfied=0" (left) to "very satisfied=100" (right), for each implant.
Time frame: 3 - 6 - 12 months
Periodontal probe
Time frame: 3 - 6 - 12 months
Periodontal probe
Misr International University
Other
Clinical and Radiographic Evaluation of Implants Placed Without Bone Grafts in Two Different Sinus Floor Elevation Techniques. A Randomized Controlled Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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