Suez Canal University
Ismailia, 41522, Egypt
NCT Number: NCT06265467
A clinical Trial, comparing two different techniques to elevate the maxillary sinus floor membrane to allow for simultaneous dental implant placement in the severely atrophied maxillary ridges.Both using allogenic bone substitute as the bone graft material. One technique is the open lateral window technique and the second is the closed crestal technique.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Ismailia, 41522, Egypt
Following extraction of posterior teeth in the maxillary arch, maxillary sinus pneumatization may pause a difficulty for dental implant placement. This difficulty may be overcome by maxillary sinus elevation with or without bone grafting or the use of short implants. Yet the literature available does not give conclusive answers as to what is the best approach for each clinical situation.
Aim of this study is to evaluate implants placed simultaneously with maxillary sinus bone augmentation using two different sinus floor elevation techniques. Null Hypothesis: There is no statistically significant difference between implants placed with crestal sinus approach and lateral sinus floor elevation, using bone grafting in both techniques, regarding implant stability and radiographic bone height gain.
Alternative Hypothesis: There is statistically significant difference between implants placed with crestal sinus approach and lateral sinus floor elevation, using bone grafting in both techniques, regarding implant stability and radiographic bone height gain.
Thirty implants in patients having posterior edentulism with maxillary sinus pneumatization were studied. All patients were be randomly allocated into two groups, group 1 (test group) had dental implants placed after crestal approach for sinus elevation, while group 2 (control group) had dental implants placed after lateral approach for maxillary sinus elevation. Both groups received allogenic bone grafts in the elevated sites. To assess implant stability, a resonance frequency analysis (RFA) device was used, for each implant the implant stability quotient (ISQ) values was measured on four sites over the implant. Mean values were calculated for each implant from the four recorded values. ISQ values were recorded immediately post-implant insertion, 9 months (after delivery of the final prosthesis) and at 12 post- operative. Cone Beam Computed Tomography (CBCT)s were made at 6 and 12 months post-operative to evaluate the radiographic bone changes in vertical dimension of bone height gained around each implant.
Steps of the clinical Procedures:
The patients were divided into two groups with a random allocation sequence generator.
After administration of local anesthesia, the allocation was revealed, for the test group, a full thickness flap was elevated at the edentulous site with two vertical releasing incision and then the preparation of osteotomy was prepared following standard implant system protocol preparation of the osteotomy. Drilling was done gently till reaching 0-1mm from the sinus floor, then in fracture of the sinus floor was done using osteotomes followed by bone grafting to raise the sinus floor from 3-5 mm and finally implant placement. For the control group, a full-thickness flap was 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 was 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 was elevated across the sinus floor and up the medial wall and this elevation extended anteriorly-posteriorly to provide the exposed sinus floor. Drilling was done gently till reaching 0-1mm from the sinus floor, then implant placement and bone grafting took place. Primary stability of the implant was measured by rotational insertion torque value, to be ≥30 Nano centimeter(25). A resorbable collagen membrane was placed over the window preparation in the lateral approach to prevent the flap tissue from entering inside the antrostomy and the influencing the osseointegration process. Primary closure of the flap was achieved.
Appropriate postoperative care was given to the patients and proper medications prescribed to them.
Patient self-care instructions:
After 9 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
Exclusion criteria
using a unique design of osteotomes to crestally elevate the Schneiderian membrane of the maxillary sinus floor
Other names: Crestal approach to elevate the maxillary sinus membrane, Osteotome Technique
using a unique design of sinus elevators to laterally elevate the Schneiderian membrane of the maxillary sinus floor
Other names: Lateral Approach to elevate the maxillary sinus Membrane
Time frame: immediate postoperative- 9 months- 12 months
Resonance Frequency analysis (RFA) a Device Named "Ostell" Device for measuring RFA
Time frame: immediate post-operative- 6 months-12 months
CBCT linear measurements using the ruler tool in the CBCT software to assess radiographic vertical bone height gain in millimeter in both techniques
Misr International University
Other
Assessment of Implants Placed Simultaneously With Maxillary Sinus Bone Augmentation Using Two Different Sinus Elevation Techniques: A Randomized Control Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Published trials that share one or more normalized conditions with this study.
NCT06206577
Alveolar Ridge Augmentation
Al Mansurah, Egypt
View Trial DetailsNCT06200077
Alveolar Ridge Augmentation
Al Mansurah, Dakahlyia, Egypt
View Trial DetailsNCT06177899
Alveolar Bone Loss, Alveolar Ridge Augmentation
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT03468998
Alveolar Ridge Augmentation, Alveolar Ridge Preservation
Birmingham, Alabama, United States
View Trial Details