Trephine Osteotomy in Lateral Sinus Lift

Lateral Sinus Lift Technique Using Trephine Osteotomy With Simultaneous Implant Placement (Clinical Trial)

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.

Study Overview

• Status: Unknown
• Conditions: Sinus Lift
• Intervention / Treatment: Procedure: Trephine osteotomy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sinus lifting with trephine osteotomy	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Implant stability	This will be measured by implant stability meter (OsstellTM)	at baseline and 6 months
change in bone density	Panoramic radiography will be performed immediately postoperatively and cone beam computed tomography (CBCT)	at baseline, 3rd and 6th months
change in bone volume	Panoramic radiography will be performed immediately postoperatively and cone beam computed tomography (CBCT)	at baseline, 3rd and 6th months
change in bone vertical bone height	Panoramic radiography will be performed immediately postoperatively and cone beam computed tomography (CBCT)	at baseline, 3rd and 6th months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative pain	This will be assessed using a 10-point Visual Analogue Scale (VAS) in the 1st week postoperatively. (0-1=None, 2-4=Mild-Moderate, 8-10= Severe)	after 1 week
Postoperative edema	None (no inflammation).; Mild (intraoral swelling confined to the surgical field).; Moderate (extraoral swelling in the surgical zone).; Severe (extraoral swelling spreading beyond the surgical zone	after 1 week

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Anticipated): January 30, 2021
• Study Completion (Anticipated): January 30, 2021

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Trephine osteotomy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No