Trephine Osteotomy in Lateral Sinus Lift

Sinus Lift Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04625192
• Other study ID #: Trephine osteotomy
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: January 30, 2021

Study information

• Verified date: November 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: January 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Sinus Lift

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

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