Use of Specifically Designed Drills for Internal Sinus Lifting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-03

Study Completion Date

2024-01-22

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Vertical Alveolar Bone Loss Sinus Lifting Implant Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control Group

Sinus lifting and implant placement with osteotomes

Group Type ACTIVE_COMPARATOR

Sinus lifting and implant placement with osteotomes

Intervention Type PROCEDURE

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

Test Group

Sinus lifting and implant placement with specifically designed drills

Group Type EXPERIMENTAL

Sinus lifting and implant placement with specifically designed drills

Intervention Type PROCEDURE

Sequential drills were used for sinus membrane elevation and implant insertion

Interventions

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Sinus lifting and implant placement with osteotomes

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

Intervention Type PROCEDURE

Sinus lifting and implant placement with specifically designed drills

Sequential drills were used for sinus membrane elevation and implant insertion

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes