Maxillary Sinus Elevation and Perioperative Complications

Not Applicable

Completed

• Conditions: Maxillary Sinus Augmentation
• Interventions: Procedure: maxillary sinus lift with conventional burr; Procedure: maxillary sinus lift with reamer; Procedure: maxillary sinus lift with piezzo

• Registration Number: NCT06601816
• Lead Sponsor: T.C. ORDU ÜNİVERSİTESİ

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.

Study Timeline

• Study Start: 2023-06-12
• Primary Completion: 2023-12-14
• Study Completion: 2023-12-14
• Status Verified: 2024-09
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-14
• Last Update Submitted: 2024-09-14
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Group	maxillary sinus lift with conventional burr	The group in which the lateral window was created with conventional rotary instrument burs
Reamer Group	maxillary sinus lift with reamer	The group in which the lateral window was created with conventional rotary instrument burs
Piezo surgery with Surgical Guide Group	maxillary sinus lift with piezzo	The group in which the lateral window was created using piezo surgery and surgical guide

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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
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.
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)

Trial Locations

Locations (1)

Ordu University; 🇹🇷 Ordu, Altınordu, Turkey