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Completed

NCT Number: NCT06601816

Maxillary Sinus Elevation and Perioperative Complications

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

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Key information

Conditions

Maxillary Sinus Augmentation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ordu University

Ordu, Altınordu, 52200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

maxillary sinus lift with reamer

Procedure

Lateral window created with specially designed burs for lateral sinus lift

maxillary sinus lift with piezzo

Procedure

lateral window was created using piezo surgery and surgical guide

maxillary sinus lift with conventional burr

Procedure

the lateral window was created with conventional rotary instrument burs

Primary outcomes

  1. Operation Time

    Time frame: 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 outcomes

  1. Patient Experience

    Time frame: 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)

  2. Pain

    Time frame: from 6 hours to postoperative 7 days

    intensity of pain experienced by patients assessed using a 10-cm Visual Analogue Scale (VAS)

  3. Analgesic Consumption

    Time frame: from 6 hours to 7 days postoperatively

    need for analgesics

  4. Edema

    Time frame: 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.

  5. Quality of Life

    Time frame: 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).

  6. Surgeon;s Comfort

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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