Trephine Osteotomy in Lateral Sinus Lift

Not Applicable

• Conditions: Sinus Lift
• Interventions: Procedure: Trephine osteotomy

• Registration Number: NCT04625192
• Lead Sponsor: Hams Hamed Abdelrahman

Brief 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.

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 Timeline

• Study Start: 2020-02-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-06
• Study First Submitted QC: 2020-11-06
• Last Update Submitted: 2020-11-06
• Study First Posted: 2020-11-12
• Last Update Posted: 2020-11-12
• Primary Completion: 2021-01-30
• Study Completion: 2021-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sinus lifting with trephine osteotomy	Trephine osteotomy	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Postoperative edema	after 1 week	* 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
post operative pain	after 1 week	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)

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt