Use of Specifically Designed Drills for Internal Sinus Lifting

Not Applicable

Completed

• Conditions: Vertical Alveolar Bone Loss; Sinus Lifting; Implant Therapy

• Registration Number: NCT06640127
• Lead Sponsor: Ege University

Brief Summary

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.

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 Timeline

• Study Start: 2022-01-03
• Primary Completion: 2023-10-17
• Study Completion: 2024-01-22
• Status Verified: 2024-10
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean of implant insertion quantity (ISQ) value	at surgery	Calculation of ISQ value for each implant
Mean of torque value	at surgery	Calculation of torque value for each implant

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ege University Faculty of Dentistry; 🇹🇷 İzmir, Bornova, Turkey