Maxillary Sinus Elevation and Perioperative Complications

NCT06601816 | Completed

• 2 other identifiers: B-232323-AKD-48
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Maxillary Sinus Augmentation

Keywords

Sinus floor augmentation; computer-aided design; piezosurgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Patient Experience

  7th postoperative day

• Pain

  from 6 hours to postoperative 7 days

• Analgesic Consumption

  from 6 hours to 7 days postoperatively

• Edema

  on the 2nd and 7th days

• Quality of Life

  preoperatively and on postoperative day 7

Study Arms (3)

Reamer Group

ACTIVE COMPARATOR

The group in which the lateral window was created with conventional rotary instrument burs

Procedure: maxillary sinus lift with reamer

Piezo surgery with Surgical Guide Group

ACTIVE COMPARATOR

The group in which the lateral window was created using piezo surgery and surgical guide

Procedure: maxillary sinus lift with piezzo

Conventional Group

ACTIVE COMPARATOR

The group in which the lateral window was created with conventional rotary instrument burs

Procedure: maxillary sinus lift with conventional burr

Interventions

maxillary sinus lift with reamer PROCEDURE

Lateral window created with specially designed burs for lateral sinus lift

Reamer Group

maxillary sinus lift with piezzo PROCEDURE

lateral window was created using piezo surgery and surgical guide

Piezo surgery with Surgical Guide Group

maxillary sinus lift with conventional burr PROCEDURE

the lateral window was created with conventional rotary instrument burs

Conventional Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients over 18 years of age
• Patients without a history of reconstructive pre-prosthetic surgery or previous implant surgery
• Patients with partial edentulism who have applied to our center for implant treatment and need sinus lifting
• Patients with cone beam computed tomography (CBCT) taken within the last 1 month

You may not qualify if:

• Patients with a history of systemic diseases (hematologic, neurologic, etc.) that may be contraindicated surgery
• Patients who are pregnant or in lactation period
• Patients with a history of immune system disorders and substance abuse
• Patients with a history of radiotherapy in the head and neck region
• Patients with existing maxillary sinus pathology or who have undergone surgery
• Patients who smoke \>10 cigarettes per day
• Patients using antibiotics or steroids in the 30 days before surgery
• Uncooperative patients who do not comply with the study protocol or follow-up regimen
• Patients with perforation of the Schneiderian membrane

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Ordu University

Ordu, Altınordu, 52200, Turkey (Türkiye)

Location

Related Publications (1)

• Ozyalcin MS, Omezli MM, Torul D. Effects of Different External Sinus Lifting Techniques on Perioperative Complications and Patient Comfort. Clin Implant Dent Relat Res. 2025 Jun;27(3):e70044. doi: 10.1111/cid.70044.

  PMID: 40320286 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: June 12, 2023
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)