Use of Specifically Designed Drills for Internal Sinus Lifting

NCT06640127 | Completed

• 2 other identifiers: 22-4.1/3023834
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertical Alveolar Bone Loss; Sinus Lifting; Implant Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Marginal bone loss

  through study completion, an average of 1 year

• Implant survival

  through study completion, an average of 1 year

• Pain Score

  at postoperative first week

• Analgesic consumption

  at postoperative first week

• Oral health impact profile questionnaire

  preoperatively, at postoperative first week, and at postoperative 6 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Sinus lifting and implant placement with osteotomes

Procedure: Sinus lifting and implant placement with osteotomes

Test Group

EXPERIMENTAL

Sinus lifting and implant placement with specifically designed drills

Procedure: Sinus lifting and implant placement with specifically designed drills

Interventions

Sinus lifting and implant placement with osteotomes PROCEDURE

Osteotomes with increasing diameters were used for sinus membrane elevation and implant insertion

Control Group

Sinus lifting and implant placement with specifically designed drills PROCEDURE

Sequential drills were used for sinus membrane elevation and implant insertion

Test Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Faculty of Dentistry

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Study Officials

• Gözde Işık

  Ege University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: January 3, 2022
• Primary Completion: October 17, 2023
• Study Completion: January 22, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)