Use of Specifically Designed Drills for Internal Sinus Li... | NCT06640127

Studies
Use of Specifically Designed Drills for Internal Sinus Lifting

NCT06640127

Sponsor

Ege University

Status

Completed

Last Update Posted

Oct 15, 2024Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Vertical Alveolar Bone Loss
Sinus Lifting
Implant Therapy

Interventions

Sinus lifting and implant placement with osteotomes
Sinus lifting and implant placement with specifically designed drills

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
23834	Other Grant/Funding Number	Ege University

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 3, 2022Actual

Primary Completion Date

Oct 17, 2023Actual

Completion Date

Jan 22, 2024Actual

First Submitted Date

Oct 9, 2024

First Submission Date that Met QC Criteria

Oct 10, 2024

First Posted Date

Oct 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2024

Last Update Posted Date

Oct 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Sinus lifting and implant placement with osteotomes	Procedure	Osteotomes with increasing diameters were used for sinus membrane elevation and implant insertion	Control Group

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gözde Işık	Ege University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ege University Faculty of Dentistry		Izmir	Bornova	35100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided