Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06265467 |
Other study ID # |
28909108800228 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2022 |
Est. completion date |
July 1, 2023 |
Study information
Verified date |
February 2024 |
Source |
Misr International University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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:
1. Clinical and radiographic evaluation:
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 was 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 were divided into two groups with a random allocation sequence generator.
3. Surgical procedure:
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.
4. Postoperative Care:
Appropriate postoperative care was given to the patients and proper medications prescribed to
them.
Patient self-care instructions:
- Application of an ice pack 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 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 six,nine and twelve
months.
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.