Evaluation of Implants Placed Without Bone Grafts in Two Different Sinus Floor Elevation Techniques.
NCT ID: NCT04309682
Last Updated: 2024-08-26
Study Results
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Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2021-12-01
2024-08-21
Brief Summary
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Detailed Description
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1. Evaluation of the patient's general condition of the oral cavity, to make sure it complies with the criteria required to be enrolled in the study in terms of oral hygiene, pathological conditions, occlusion and inter-arch space.
2. A preoperative CBCT will be performed for each patient prior to the surgery. Evaluation of available bone height and bucco-palatal bone width. Suitable implant length and diameter will be determined as well.
2. Random allocation: The patients will be divided into two groups with random allocation. Allocation ratio is 1:1. Randomization list will be provided using computerized excel sheet and will be concealed to the principle investigator till the time of the surgery, and will be kept with a contributor (Ingy Kastour) a clinician in IDCE who is not involved in the trial procedures. A phone call will be done after administration of anesthesia to reveal the randomization sequence for each case.
3. Blinding: The outcome assessors will be blinded, the outcome assessor (CoI-II) for the implant stability and the outcome assessor (CoI-V) for the vertical bone height difference obtained from blinded CBCTs, outcome assessor (CoI-III) of the other variables will be also blinded. Blinding of the principle investigator and participants cannot be achieved due to different surgical procedures
4. Surgical procedure:
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.
5. Postoperative Care:
1. Antibiotics (Amoxicillin 1g orally- twice daily for 5 days).
2. Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily for 5 days).
3. Antiseptic mouth rinse (0.12% Chlorhexidine oral rinse) will be prescribed starting from the second day for 60 seconds, 15 ml each time, two times a day for 14 days.
4. Patient self-care instructions:
* Application of an ice bag to the treated area for the first 24 hours will be instructed.
* The patients will be instructed to gently brush the operated area after two weeks with a soft brush.
* In case of emergency; severe pain and bleeding, the patient will call the co-investigator and will be presented to the clinic.
* Patients will be recalled after two weeks for suture removal and every month for supportive periodontal therapy and recording of outcome variables at three, six and twelve months.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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crestal sinus approach technique
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
crestal sinus approach technique
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 elevation technique
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 plac
Lateral 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
Interventions
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crestal sinus approach technique
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 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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Pregnant and lactating females
3. Medically compromised patients. as Uncontrolled diabetic patients, patients taking bisphosphonates injection for treatment of osteoporosis, patients with active cardiac diseases, patients undergoing radiotherapy or chemotherapy, or any other medical and general contraindications for the surgical procedure (i.e. ASA score ≥III)
4. Patients with active infection related at the site of implant/bone graft placement.
5. Patients with untreated active periodontal diseases.
6. Patients with parafunctional habits.
7. Acute or chronic sinusitis.
18 Years
50 Years
ALL
Yes
Sponsors
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Misr International University
OTHER
Responsible Party
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Ahmed Abo El Futtouh
Clinical Director of Implant Program - Periodontology and Implantology Consultant
Principal Investigators
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Ahmed I Abo El Futtouh, Master
Role: PRINCIPAL_INVESTIGATOR
Clinical Director of Implant Program - Misr International University
Inas M El-Zayat, Doctor
Role: STUDY_DIRECTOR
Assoc. Professor - Operative department, Misr International University
Mariam S Hanna, Bsc
Role: STUDY_DIRECTOR
Dentist/Researcher - IDCE
Nael A Mina, Bsc
Role: STUDY_CHAIR
Misr International University
Abdel Rahman A Abdel Rahman, Master
Role: STUDY_CHAIR
International Dental Contiuing Education
Locations
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International Dental Continuing Education (IDCE) centre
Cairo, , Egypt
Countries
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References
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Other Identifiers
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PER8273004
Identifier Type: -
Identifier Source: org_study_id
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