Maxillary Sinus Elevation and Perioperative Complications

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

This study aims to investigate the effects of various external sinus lifting techniques on patient comfort and perioperative complications.

Study Overview

• Status: Completed
• Conditions: Maxillary Sinus Augmentation
• Intervention / Treatment: Procedure: maxillary sinus lift with reamer; Procedure: maxillary sinus lift with piezzo; Procedure: maxillary sinus lift with conventional burr

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Altınordu
    • Ordu, Altınordu, Turkey, 52200
      • Ordu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reamer Group; The group in which the lateral window was created with conventional rotary instrument burs	Procedure: maxillary sinus lift with reamer; Lateral window created with specially designed burs for lateral sinus lift
Active Comparator: Piezo surgery with Surgical Guide Group; The group in which the lateral window was created using piezo surgery and surgical guide	Procedure: maxillary sinus lift with piezzo; lateral window was created using piezo surgery and surgical guide
Active Comparator: Conventional Group; The group in which the lateral window was created with conventional rotary instrument burs	Procedure: maxillary sinus lift with conventional burr; the lateral window was created with conventional rotary instrument burs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation Time	The time from the osteotomy of the sinus window to completation of membrane elevation	from the osteotomy of the sinus window to completation of membrane elevation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Experience	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)	7th postoperative day
Pain	intensity of pain experienced by patients assessed using a 10-cm Visual Analogue Scale (VAS)	from 6 hours to postoperative 7 days
Analgesic Consumption	need for analgesics	from 6 hours to 7 days postoperatively
Edema	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.	on the 2nd and 7th days
Quality of Life	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).	preoperatively and on postoperative day 7
Surgeon;s Comfort	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)	Immediately after surgery

Collaborators and Investigators

• Sponsor: T.C. ORDU ÜNİVERSİTESİ

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Actual): December 14, 2023
• Study Completion (Actual): December 14, 2023

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 14, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 14, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Sinus floor augmentation; piezosurgery; computer-aided design
• Other Study ID Numbers: B-2323; 23-AKD-48 (Other Identifier: Turkish Medicines and Medical Devices Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No