Maxillary Sinus Augmentation
Conditions
Keywords
Sinus floor augmentation, computer-aided design, piezosurgery
Brief summary
This study aims to investigate the effects of various external sinus lifting techniques on patient comfort and perioperative complications.
Detailed description
Patients who met the inclusion criteria and were admitted for posterior maxilla rehabilitation participated in this prospective, randomized, controlled clinical trial. The three methods used to lift the sinuses were randomized: piezosurgery using a surgical guide, a drill specifically made for lateral sinus lift, and traditional drills. Recorded were the duration of the procedure, accessibility, and intraoperative complications. During the first week following surgery, analgesic intake and pain using a visual analog scale (VAS) were assessed assessed. Preoperatively and on the second and seventh postoperative days, edema was assessed. Preoperatively and on the seventh postoperative day, the patient's quality of life using the OHIP-14 questionnaire, experiences, and expectations were evaluated.
Interventions
PROCEDUREmaxillary sinus lift with reamer
Lateral window created with specially designed burs for lateral sinus lift
PROCEDUREmaxillary sinus lift with piezzo
lateral window was created using piezo surgery and surgical guide
PROCEDUREmaxillary sinus lift with conventional burr
the lateral window was created with conventional rotary instrument burs
Sponsors
Ordu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
The three methods used to lift the sinuses were randomized: piezosurgery using a surgical guide, a drill specifically made for lateral sinus lift, and traditional drills.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Severe resorption or sinus pneumatization in the posterior maxilla that prevents standard implant treatment; class V or VI according to Cawood and Howell classification, patients with residual bone height less than 6 mm 2. Patients over 18 years of age 3. Patients without a history of reconstructive pre-prosthetic surgery or previous implant surgery 4. Patients with partial edentulism who have applied to our center for implant treatment and need sinus lifting 5. Patients with cone beam computed tomography (CBCT) taken within the last 1 month
Exclusion criteria
1. Patients with a history of systemic diseases (hematologic, neurologic, etc.) that may be contraindicated surgery 2. Patients who are pregnant or in lactation period 3. Patients with a history of immune system disorders and substance abuse 4. Patients with a history of radiotherapy in the head and neck region 5. Patients with existing maxillary sinus pathology or who have undergone surgery 6. Patients who smoke >10 cigarettes per day 7. Patients using antibiotics or steroids in the 30 days before surgery 8. Uncooperative patients who do not comply with the study protocol or follow-up regimen 9. Patients with perforation of the Schneiderian membrane
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operation Time | from the osteotomy of the sinus window to completation of membrane elevation | The time from the osteotomy of the sinus window to completation of membrane elevation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain | from 6 hours to postoperative 7 days | intensity of pain experienced by patients assessed using a 10-cm Visual Analogue Scale (VAS) |
| Analgesic Consumption | from 6 hours to 7 days postoperatively | need for analgesics |
| Patient Experience | 7th postoperative day | Patients asked to rate their postoperative experience with a 3-point scale (0, my expectation and experience were the same/similar; 1, my experience was better than my expectation; 2, my experience was worse than my expectation) |
| Quality of Life | preoperatively and on postoperative day 7 | The OHIP-14 used to measure quality of life. Scores ranged from 0 (no impact) to 56 (all oral health concerns encountered extremely frequently). It was scored as follows: Never (0 points); Seldom (1 point); Sometimes (2 points); Frequently (3 points); and Very frequently (4 points). |
| Surgeon;s Comfort | Immediately after surgery | The comfort of the access to the operation site evaluated by the surgeon on a 4-point scale (0, very poor visibility; 1, fair visibility; 2, good visibility; 3, excellent visibility) |
| Edema | on the 2nd and 7th days | Swelling after surgery measurements collected of a anatomical locations on the face that served as reference points. Reference points included the tragus, alare, lateral corner of the eye, gonion, soft tissue pogonion, and external corner of the mouth. The average of each measurement was used to calculate the edema level. |
Countries
Turkey (Türkiye)
Outcome results
None listed