Trephine Osteotomy in Lateral Sinus Lift

NCT ID: NCT04625192

Last Updated: 2020-11-12

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Trephine osteotomy was used for lateral sinus lifting technique associated with sinus floor augmentation using the autogenous bone resulting from implant drilling using specialized trephine drills.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study includes 14 patients in whom the lateral sinus lift technique was performed using the trephine osteotomy with simultaneous implant placement.

Sinus floor augmentation with autogenous bone graft resulting from implant site preparation with trephine drills.

Implant stability and rate of complications such as Schneiderian membrane perforation and bleeding will be assessed.

Patients will also provide their subjective assessment of postoperative pain and swelling. Vertical bone height, that will be gained, will be assessed radiographically

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sinus Lift

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sinus lifting with trephine osteotomy

Group Type EXPERIMENTAL

Trephine osteotomy

Intervention Type PROCEDURE

* Using a trephine on a straight implant handpiece (at approximately 1800 rpm) with copious irrigation to avoid overheating the bone, a round bone cut will be made 4 -5 mm above the crest of the alveolar ridge.
* The trephine is positioned perpendicular to the lateral wall, removing the outer cortex with a very gentle touch to avoid tearing the schneiderian membrane.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Trephine osteotomy

* Using a trephine on a straight implant handpiece (at approximately 1800 rpm) with copious irrigation to avoid overheating the bone, a round bone cut will be made 4 -5 mm above the crest of the alveolar ridge.
* The trephine is positioned perpendicular to the lateral wall, removing the outer cortex with a very gentle touch to avoid tearing the schneiderian membrane.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients of both genders requiring implant placement in the posterior maxilla.
* Age between 20-50 years.
* Tooth extractions at the implant sites were performed at least 4 months before surgery.
* Residual bone height between the alveolar bone crest and the sinus floor ranges from 4 to 6 mm.
* Patients who are willing and fully capable to comply with the study protocol

Exclusion Criteria

* Maxillary sinus pathologies (sinusitis, long standing nasal obstruction)
* Any disease contraindicating surgery (e.g. uncontrolled diabetes)
* Heavy smokers
* Acute oral infections
* Poor oral hygiene
* A history of radiotherapy or chemotherapy of the head and neck region
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hams Hamed Abdelrahman

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Trephine osteotomy

Identifier Type: -

Identifier Source: org_study_id