Computer Guided Low Window Sinus Lift Technique

NCT04618588 | Completed

• 1 other identifier: Sinus lift
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The study group included 12 patients that were treated using the low window lateral sinus lift technique with simultaneous implant placement. This was facilitated using a CAD-CAM generated surgical guide. Subjective assessment on postoperative pain and swelling as well as objective assessment of implant stability, vertical bone height gained and complications such as Schneiderian membrane perforation rates and bleeding.

Conditions

Sinus Perforation

Keywords

sinus augmentation

Outcome Measures

Primary Outcomes (2)

• Presence or absence of intra or postoperative complications

  * Schneiderian membrane perforation occurrence is noted intraoperatively * Intra/post operative bleeding, postoperative sinusitis, periimplantitis

  6 months

• Postoperative pain

  This was assessed using a 10-point Visual Analogue Scale (VAS) in the 1st week postoperatively. (0-1=None, 2-4=Mild-Moderate, 8-10= Severe)

  1 week

Secondary Outcomes (5)

• Implant stability

  6 months

• Postoperative edema

  1 week

• Bone Density

  6 months

• Vertical bone height gained

  6 months

• Marginal bone loss

  6 months

Study Arms (1)

Sinus elevation using "Low Window Sinus Lift" technique

EXPERIMENTAL

Procedure: Low Window Sinus Lift technique

Interventions

Low Window Sinus Lift technique PROCEDURE

Preoperative CBCT of surgical site and Fabrication CAD/CAM surgical stent, Sinus elevation using "Low Window Sinus Lift" technique, Implant, bone graft and membrane placement

Sinus elevation using "Low Window Sinus Lift" technique

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients requiring implant placement in the posterior maxilla (Kennedy Classification: Class 1 and Class 2).
• Age between 20-60 years irrespective of the gender.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Related Publications (35)

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Study Officials

• Nagy H Elprince, pHd

  Alexandria University

  STUDY DIRECTOR

• Riham M Fliefel, pHd

  Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: November 6, 2020
• Study Start: January 1, 2019
• Primary Completion: December 17, 2019
• Study Completion: December 17, 2019
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)