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Clinical Trials/CTRI/2024/08/072247
CTRI/2024/08/072247Not yet recruitingPhase 3 4

Comparative evaluation of extent of sinus lift achieved by crestal approach and Osseodensification: A Randomized controlled trial

Department of Periodontology SMBT IDSR Dhamangaon Nashik1 site in 1 country36 target enrollmentStarted: December 2, 2024Last updated:

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Enrollment
36
Locations
1
Primary Endpoint
Primary outcome will be extent of sinus lift achieved

Study Overview

Brief Summary

With the rise of implant dentistry, dental implants have become the favored and reliable method for replacing missing teeth. However, optimal osseointegration after implant placement requires sufficient quality and quantity of live bone surrounding the osteotomy, ideally 2mm or more. Sinus pneumatization poses a challenge to successful endosseous implant placement in the posterior maxilla. Elevating the sinus is often necessary to facilitate implant placement, requiring the operating clinician’s familiarity with sinus anatomy to prevent intraoperative complications. Various techniques for sinus augmentation have been developed and proven to yield successful outcomes. Over half of implants inserted in the posterior maxilla necessitate sinus floor elevation (SFE). This necessity arises from continuous ridge resorption following tooth extraction, coupled with progressive sinus pneumatization and the common occurrence of poor bone quality in the maxilla. Sinus membrane perforation is identified as the primary complication during SFE procedures, with the incidence varying based on the technique employed. Perforations may occur during either the fracturing of the sinus floor or the elevation of the mucosa. Here, we will compare two distinct techniques of indirect sinus lift, known interchangeably as sinus lift, sinus augmentation, sinus floor elevation, or augmentation of an atrophic maxillary sinus. The two techniques of indirect sinus lifting we will compare are

1.) Crestal approach

2.) Osseodensification approach

The crestal approach to the sinus offers a safe and effective method for sinus elevation. This approach utilizes a reamer, known as the CAS drill, to create a conical-shaped osteotomy and fracture the bony floor. The osseodensification (OD) technique involves a specialized set of burs that operate through a non-excavating drilling process. Rotating counterclockwise, these burs induce low plastic deformation of trabecular bone, leading to bone accumulation apically and laterally. This approach has demonstrated high success rates in crestal sinus floor elevation with minimal risk of membrane perforation, utilizing osseodensification (OD) burs, which rotate in the noncutting counterclockwise (CCW) direction

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Investigator Blinded

Eligibility Criteria

Ages
25.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Single or multiple edentulous sites in posterior maxillary region indicated for implant placement.
  • Residual bone height (between alveolar crest and sinus floor) is in the range of 4 -8 mm
  • Systemically healthy individuals
  • Pneumatized maxillary sinus.

Exclusion Criteria

  • Pregnant patients
  • Active sinus infection and inflammation
  • Recent or unhealed extraction sites
  • Patients with medically compromised health
  • Immediate implant placement.

Outcomes

Primary Outcomes

Primary outcome will be extent of sinus lift achieved

Time Frame: Preoperative and baseline

Secondary Outcomes

  • Operators satisfaction & time required for surgery in minutes from baseline to 60 mins(Baseline)

Investigators

Sponsor
Department of Periodontology SMBT IDSR Dhamangaon Nashik
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Pooja Pawar

SMBT IDSR, Dhamangaon, Nashik

Study Sites (1)

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