Dental Implant PlacementNCT04309682
Evaluation of Implants Placed Without Bone Grafts in Two Different Sinus Floor Elevation Techniques.
A study testing crestal sinus approach technique and Lateral sinus approach in people with Dental Implant Placement, run by Misr International University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Placement
- What is being tested?
- crestal sinus approach technique and Lateral sinus approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 21 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Smokers.
- Pregnant and lactating females
- 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)
- Patients with active infection related at the site of implant/bone graft placement.
- Patients with untreated active periodontal diseases.
- Patients with parafunctional habits.
- Acute or chronic sinusitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Implants Placed Without Bone Grafts in Two Different Sinus Floor Elevation Techniques. A Randomized Controlled Clinical Trial
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.
Read the detailed description
- Clinical examination and preoperative evaluation using CBCT:
- 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.
- 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.
- 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.
- 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
- 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.
- Postoperative Care:
- Antibiotics (Amoxicillin 1g orally- twice daily for 5 days).
- Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily for 5 days).
- 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.
- 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
- Dental Implant Placement
- Being tested
- crestal sinus approach technique, Lateral sinus approach
- Keywords
- Crestal sinus approach, lateral sinus approach, implant stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crestal sinus approach techniqueProcedure or surgery
Also called zimmer biomed dental implants and crestal sinus approach
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 or surgery
Also called Zimmer biomed dental implants and 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
| Study group | Role | What they receive |
|---|---|---|
| crestal sinus approach technique | Experimental | 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 Receives: Procedure: crestal sinus approach technique |
| lateral sinus elevation technique | Active comparator | 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 Receives: Procedure: Lateral sinus approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term Implant stability
Implant stability will be measured using Osstell to assess any changes in the implant stability over time and changes from baseline
Measured: 3 - 6 - 12 months
Secondary outcomes (5)
Vertical bone height gain
Measured by CBCT
Measured: 3 - 12 months
Post-surgical pain
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).
Measured: for 10 days after the surgery
Patient satisfaction regarding the function
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.
Measured: 12 months
Plaque Index
Periodontal probe
Measured: 3 - 6 - 12 months
Modified Bleeding Index
Periodontal probe
Measured: 3 - 6 - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Dec 2021
- Primary completion1 Jul 2024
- Study completion21 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Dental Implant PlacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abo El Futtouh, Misr International University
- Investigators
- Ahmed I Abo El Futtouh, Master, Principal investigator, Clinical Director of Implant Program - Misr International UniversityInas M El-Zayat, Doctor, Study director, Assoc. Professor - Operative department, Misr International UniversityMariam S Hanna, Bsc, Study director, Dentist/Researcher - IDCENael A Mina, Bsc, Study chair, Misr International UniversityAbdel Rahman A Abdel Rahman, Master, Study chair, International Dental Contiuing Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309682
- Sponsor's protocol ID
- PER8273004
- Status last verified
- Aug 2024
- First submitted
- 9 Mar 2020
- Last updated
- 26 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data can be shared
Publications
ROSEN MD, SARNAT BG. Change of volume of the maxillary sinus of the dog after extraction of adjacent teeth. Oral Surg Oral Med Oral Pathol. 1955 Apr;8(4):420-9. doi: 10.1016/0030-4220(55)90111-0. No abstract available.
PubMed 14370769Sharan A, Madjar D. Maxillary sinus pneumatization following extractions: a radiographic study. Int J Oral Maxillofac Implants. 2008 Jan-Feb;23(1):48-56.
PubMed 18416412Misch CE, Steignga J, Barboza E, Misch-Dietsh F, Cianciola LJ, Kazor C. Short dental implants in posterior partial edentulism: a multicenter retrospective 6-year case series study. J Periodontol. 2006 Aug;77(8):1340-7. doi: 10.1902/jop.2006.050402.
PubMed 16937587de Sa e Frias V, Toothaker R, Wright RF. Shortened dental arch: a review of current treatment concepts. J Prosthodont. 2004 Jun;13(2):104-10. doi: 10.1111/j.1532-849X.2004.04016.x.
PubMed 15210006Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.
PubMed 3516738Boyne PJ, James RA. Grafting of the maxillary sinus floor with autogenous marrow and bone. J Oral Surg. 1980 Aug;38(8):613-6. No abstract available.
PubMed 6993637Zitzmann NU, Scharer P. Sinus elevation procedures in the resorbed posterior maxilla. Comparison of the crestal and lateral approaches. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Jan;85(1):8-17. doi: 10.1016/s1079-2104(98)90391-2.
PubMed 9474608Smiler DG. The sinus lift graft: basic technique and variations. Pract Periodontics Aesthet Dent. 1997 Oct;9(8):885-93; quiz 895.
PubMed 9573843Boyne PJ. Analysis of performance of root-form endosseous implants placed in the maxillary sinus. J Long Term Eff Med Implants. 1993;3(2):143-59.
PubMed 10146541Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162.
PubMed 8055503Hallman M, Thor A. Bone substitutes and growth factors as an alternative/complement to autogenous bone for grafting in implant dentistry. Periodontol 2000. 2008;47:172-92. doi: 10.1111/j.1600-0757.2008.00251.x. No abstract available.
PubMed 18412581Marx RE, Carlson ER, Eichstaedt RM, Schimmele SR, Strauss JE, Georgeff KR. Platelet-rich plasma: Growth factor enhancement for bone grafts. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Jun;85(6):638-46. doi: 10.1016/s1079-2104(98)90029-4.
PubMed 9638695Lundgren S, Andersson S, Gualini F, Sennerby L. Bone reformation with sinus membrane elevation: a new surgical technique for maxillary sinus floor augmentation. Clin Implant Dent Relat Res. 2004;6(3):165-73.
PubMed 15726851Vercellotti T, De Paoli S, Nevins M. The piezoelectric bony window osteotomy and sinus membrane elevation: introduction of a new technique for simplification of the sinus augmentation procedure. Int J Periodontics Restorative Dent. 2001 Dec;21(6):561-7.
PubMed 11794567Srouji S, Kizhner T, Ben David D, Riminucci M, Bianco P, Livne E. The Schneiderian membrane contains osteoprogenitor cells: in vivo and in vitro study. Calcif Tissue Int. 2009 Feb;84(2):138-45. doi: 10.1007/s00223-008-9202-x. Epub 2008 Dec 9.
PubMed 19067018
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Implants Placed Without Bone Grafts in Two Different Sinus Floor Elevation Techniques. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04309682
- Acronym / sponsor ID
- PER8273004
- Conditions
- Dental Implant Placement
- Keywords
- Crestal sinus approach, lateral sinus approach, implant stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 21 Aug 2024 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Clinical examination and preoperative evaluation using CBCT:
- 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.
- 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.
- 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.
- 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
- 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.
- Postoperative Care:
- Antibiotics (Amoxicillin 1g orally- twice daily for 5 days).
- Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily for 5 days).
- 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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| crestal sinus approach technique | Experimental | Procedure: crestal sinus approach techniqueFull 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 | Active comparator | Procedure: Lateral sinus approacha 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- Smokers.
- Pregnant and lactating females
- 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)
- Patients with active infection related at the site of implant/bone graft placement.
- Patients with untreated active periodontal diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| crestal sinus approach techniqueAlso: zimmer biomed dental implants and crestal sinus approacha 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. | Procedure or surgery | crestal sinus approach technique |
| Lateral sinus approachAlso: Zimmer biomed dental implants and lateral sinus approacha 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 | Procedure or surgery | lateral sinus elevation technique |
Primary outcome
Long term Implant stability
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
5 secondary outcomes
Vertical bone height gain
Time frame: 3 - 12 months
Post-surgical pain
Time frame: for 10 days after the surgery
Patient satisfaction regarding the function
Time frame: 12 months
Plaque Index
Time frame: 3 - 6 - 12 months
Modified Bleeding Index
Time frame: 3 - 6 - 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Background: PubMed 14370769ROSEN MD, SARNAT BG. Change of volume of the maxillary sinus of the dog after extraction of adjacent teeth. Oral Surg Oral Med Oral Pathol. 1955 Apr;8(4):420-9. doi: 10.1016/0030-4220(55)90111-0. No abstract available.
- Background: PubMed 18416412Sharan A, Madjar D. Maxillary sinus pneumatization following extractions: a radiographic study. Int J Oral Maxillofac Implants. 2008 Jan-Feb;23(1):48-56.
- Background: PubMed 16937587Misch CE, Steignga J, Barboza E, Misch-Dietsh F, Cianciola LJ, Kazor C. Short dental implants in posterior partial edentulism: a multicenter retrospective 6-year case series study. J Periodontol. 2006 Aug;77(8):1340-7. doi: 10.1902/jop.2006.050402.
- Background: PubMed 15210006de Sa e Frias V, Toothaker R, Wright RF. Shortened dental arch: a review of current treatment concepts. J Prosthodont. 2004 Jun;13(2):104-10. doi: 10.1111/j.1532-849X.2004.04016.x.
- Background: PubMed 3516738Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.
- Background: PubMed 6993637Boyne PJ, James RA. Grafting of the maxillary sinus floor with autogenous marrow and bone. J Oral Surg. 1980 Aug;38(8):613-6. No abstract available.
- Background: PubMed 9474608Zitzmann NU, Scharer P. Sinus elevation procedures in the resorbed posterior maxilla. Comparison of the crestal and lateral approaches. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Jan;85(1):8-17. doi: 10.1016/s1079-2104(98)90391-2.
- Background: PubMed 9573843Smiler DG. The sinus lift graft: basic technique and variations. Pract Periodontics Aesthet Dent. 1997 Oct;9(8):885-93; quiz 895.
- Background: PubMed 10146541Boyne PJ. Analysis of performance of root-form endosseous implants placed in the maxillary sinus. J Long Term Eff Med Implants. 1993;3(2):143-59.
- Background: PubMed 8055503Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162.
- Background: PubMed 18412581Hallman M, Thor A. Bone substitutes and growth factors as an alternative/complement to autogenous bone for grafting in implant dentistry. Periodontol 2000. 2008;47:172-92. doi: 10.1111/j.1600-0757.2008.00251.x. No abstract available.
- Background: PubMed 9638695Marx RE, Carlson ER, Eichstaedt RM, Schimmele SR, Strauss JE, Georgeff KR. Platelet-rich plasma: Growth factor enhancement for bone grafts. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Jun;85(6):638-46. doi: 10.1016/s1079-2104(98)90029-4.
- Individual participant dataSharing planned: Yes. All data can be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed I Abo El Futtouh, Master principal investigator
Clinical Director of Implant Program - Misr International University
Inas M El-Zayat, Doctor study director
Assoc. Professor - Operative department, Misr International University
Mariam S Hanna, Bsc study director
Dentist/Researcher - IDCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing crestal sinus approach technique and Lateral sinus approach in people with Dental Implant Placement, run by Misr International University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term Implant stability (time frame: 3 - 6 - 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04309682, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.