Use of Specifically Designed Drills for Internal Sinus Lifting

A Randomized Comparative Study on Internal Sinus Lifting With Simultaneous Implant Placement Using Two Different Techniques

This study was conducted at Ege University, School of Dentistry, Izmir, Turkey. Patients enrolled require implant placement to the atrophic posterior maxilla. Patients were treated with either the specifically designed drills or the osteotomes. The outcome variables were primary stability, marginal bone loss, implant survival, and patient-reported outcomes. The investigators aimed to compare the treatment outcomes of two different techniques used in dental implant placement with internal sinus lifting.

Study Overview

• Status: Completed
• Conditions: Vertical Alveolar Bone Loss; Implant Therapy; Sinus Lifting
• Intervention / Treatment: Procedure: Sinus lifting and implant placement with osteotomes; Procedure: Sinus lifting and implant placement with specifically designed drills

Detailed Description

This prospective, randomized clinical study was conducted at the Ege University School of Dentistry and Department of Oral and Maxillofacial Surgery. Patients with atrophic maxillas and at least one tooth loss in this region were included. Randomization was performed to assign the patients to study groups. Patients treated with internal sinus lift using osteotome and implant surgery were assigned to Group 1, and patients treated with internal sinus lift using specifically designed drills and implant surgery were assigned to Group 2. At six months postoperatively, the healing cap was inserted during the second stage of surgery.

All implants were assessed based on primary stability (using implant stability quotient and torque value), marginal bone loss (as millimeters), and implant survival (as a percentage). Also, patient-reported outcomes were collected, including pain (using a visual analog scale), analgesic consumption (number of drugs taken during a week), and oral health impact profile survey).

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bornova
    • İzmir, Bornova, Turkey, 35100
      • Ege University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Unilaterally or bilaterally missing teeth in the posterior maxilla,
• Residual bone height (4 mm to 6 mm),
• Completed periodontal and oral hygiene treatment,
• American Society of Anesthesiologists (ASA) score of I or II,
• > 18 years old,
• Willingness to participate

Exclusion Criteria:

• Infection or pathology related to maxillary sinus and surgical site,
• Tooth extraction within six months in the surgical site,
• Previous maxillary sinus surgery,
• Parafunction,
• Medical conditions associated with impaired or delayed wound healing,
• Smoking habit and alcohol or drug abuse,
• Pregnancy or nursing

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Sinus lifting and implant placement with osteotomes	Procedure: Sinus lifting and implant placement with osteotomes; Osteotomes with increasing diameters were used for sinus membrane elevation and implant insertion
Experimental: Test Group; Sinus lifting and implant placement with specifically designed drills	Procedure: Sinus lifting and implant placement with specifically designed drills; Sequential drills were used for sinus membrane elevation and implant insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean of implant insertion quantity (ISQ) value	Calculation of ISQ value for each implant	at surgery
Mean of torque value	Calculation of torque value for each implant	at surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal bone loss	Change in peri-implant bone level	through study completion, an average of 1 year
Implant survival	Number of mobil or loss implants	through study completion, an average of 1 year
Pain Score	Pain level recorded between 0 to 10 points	at postoperative first week
Analgesic consumption	Number of analgesic taken on a daily basis	at postoperative first week
Oral health impact profile questionnaire	Total score of self-administered questionnaire assessed using Likert-point scale between 0 to 4	preoperatively, at postoperative first week, and at postoperative 6 months

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Principal Investigator: Gözde Işık, Ege University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): October 17, 2023
• Study Completion (Actual): January 22, 2024

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: 22-4.1/30; 23834 (Other Grant/Funding Number: Ege University)

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