Patient Perception and Radiographic Assessment of Sinus Lifting Procedure

NCT04481867 | Completed

• 1 other identifier: sinus lift densah bur
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the clinical complications that might be presented with osteotome and densah burs, as well as to assess the new bone generated at 6 months post-operatively using CBCT. The study hypothesis was that densah bur would show comparable results to osteotome-mediated sinus lifting

Conditions

Dental Implant Failed

Keywords

Sinus lifting; CBCT

Outcome Measures

Primary Outcomes (1)

• Clinical patient perception

  assessment with Health-Related Quality of Life (HRQOL) questionnaire

  7 days postoperative

Secondary Outcomes (1)

• Radio-graphic (CBCT) assessment

  preoperative and 6 month postoperative

Study Arms (2)

intervention arm :densah bur group

ACTIVE COMPARATOR

at the maxillary molar area for implant placement ,,just after making initial drilling perforation close to the sinus floor, the direction of the drill is reversed and the cutting speed is raised to 1200 rpm, then 2 successive densah burs are used to elevate sinus membrane 2 mm and to prepare implant hole to the selected implant size .for both groups the selected implant size, 4.2 mm width and 10 mm. length

Procedure: densah bur

control group :osteotome group

OTHER

at the maxillary molar area for implant placement .a set of concave osteotomes with different dimensions sequentially used to widen the osteotomy site by surgical mallet. Osteotome 2.5 mm is inserted into the osteotomy firstly to a depth of 1 mm away from the sinus floor with light malleting by the nylon cap mallet then 3 mm osteotome is used to fracture up the sinus floor and finally 3.5 mm osteotome is tapped gently to elevate the sinus floor to the desired depth of the implant in the maxillary sinus.

Procedure: densah bur

Interventions

densah bur PROCEDURE

osseodensification densah bur

control group :osteotome group; intervention arm :densah bur group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• the residual bone height at the site of implant placement was 8 mm or less. All patients were in a good health, non-smokers with no systemic, immunologic or debilitating diseases that could affect normal bone healing. Their edentulous ridges were covered with optimal thickness of mucoperiosteum with no signs of inflammation, ulceration or scar tissue and sufficient inter arch space was adequate for future prosthesis

You may not qualify if:

• smokers bad oral hygiene systemic disease

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry ,Cairo Uni

Cairo, Giza Governorate, 1211, Egypt

Location

Related Publications (2)

• Almutairi AS, Walid MA, Alkhodary MA. The effect of osseodensification and different thread designs on the dental implant primary stability. F1000Res. 2018 Dec 5;7:1898. doi: 10.12688/f1000research.17292.1. eCollection 2018.

  PMID: 31131085 RESULT

• Padhye NM, Padhye AM, Bhatavadekar NB. Osseodensification -- A systematic review and qualitative analysis of published literature. J Oral Biol Craniofac Res. 2020 Jan-Mar;10(1):375-380. doi: 10.1016/j.jobcr.2019.10.002. Epub 2019 Nov 2.

  PMID: 31737477 RESULT

Study Officials

• Doaa A Heshmat, lecturer

  faculty of dentistry ,Cairo Uni

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer od prosthodontic dep,

Model Details: randomized control trail

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 22, 2020
• Study Start: July 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

EG (1)