Clinical trial NCT06601816: Maxillary Sinus Elevation and Perioperative Complications
Official title: Comparison of Sinus Lifting Techniques Performed with Piezosurgery and a Surgical Guide, a Specially Designed Drill, and Conventional Drills in Terms Complications and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Sinus Augmentation
Keywords: Sinus floor augmentation
computer-aided design
piezosurgery
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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\&#39;s quality of life using the OHIP-14 questionnaire, experiences, and expectations were evaluated.

Eligibility criteria: 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 \&gt;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

Primary outcomes:
measure: Operation Time
timeFrame: from the osteotomy of the sinus window to completation of membrane elevation
Secondary outcomes:
measure: Patient Experience
timeFrame: 7th postoperative day
measure: Pain
timeFrame: from 6 hours to postoperative 7 days
measure: Analgesic Consumption
timeFrame: from 6 hours to 7 days postoperatively
measure: Edema
timeFrame: on the 2nd and 7th days
measure: Quality of Life
timeFrame: preoperatively and on postoperative day 7
measure: Surgeon;s Comfort
timeFrame: Immediately after surgery
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Ordu University
state: Altınordu
Study officials:
References: