Closed Sinus Tenting Using Densah Burs Osteotomy Versus Conventional Osteotomy in Localized Pneumatization

NCT05513170 | Unknown

• 1 other identifier: Densah Burs
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Isolated sinus pneumatization after single tooth extraction indicate sinus lifting for proper implant placement. The conventional way of using osteotomes to elevate the sinus is annoying to patient and also does not give the needed amount of bone around the implant. Introducing new intervention of Densah Burs helps increase bone gain around implant and decrease the patient discomfort.

Conditions

Edentulous Alveolar Ridge

Keywords

Densah Burs; Osteotomes; Sinus Tenting; Graftless

Outcome Measures

Primary Outcomes (1)

• Measurement of Bone Change in Cone Beam CT

  The amount of bone change will be determined by superimposing pre-operative CBCT (cone-beam computed tomography), three months post-operative, and six months post-operative CBCT.

  three and six months

Secondary Outcomes (1)

• Measurement of Primary and Secondary Implant stability using Resonance Frequency Analysis (RFA)

  At the day of implant placement and after six months

Study Arms (2)

Closed sinus lift using Densah bur

ACTIVE COMPARATOR

Closed sinus lifting will be performed using densah burs and then dental implants will be placed.

Procedure: Closed sinus lift using osteotomes

Conventional closed sinus lift using osteotomes

ACTIVE COMPARATOR

Sinus lifting will be performed using osteotomes and then dental implants will be placed.

Procedure: Use of Densah Burs in closed sinus lift

Interventions

Use of Densah Burs in closed sinus lift PROCEDURE

Closed sinus will be performed using Densah Burs. Densah Burs enhance bone quality through osseodensification; a process through which bone is compacted and auto-graphted in the marrow spaces and apically to elevate the sinus floor and enhance bone density.

Conventional closed sinus lift using osteotomes

Closed sinus lift using osteotomes PROCEDURE

Closed sinus lift will be performed using osteotomes. Osteotomes elevate the sinus floor and enhance the bone quality.

Closed sinus lift using Densah bur

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No inflamed sinus
• Minimum alveolar ridge height 5-6 mm
• Medical free
• Both genders males and females.

You may not qualify if:

• Remaining alveolar ridge height is less than 5mm
• Subjected to irradiation in the head and neck area less than 1 year before implantation.
• Patients having history of allergy to any drugs.
• Patients who have a history of any concomitant from a major known medical problem and/or ongoing pharmacologic treatments
• Untreated periodontitis.
• Poor oral hygiene and motivation.
• Uncontrolled diabetes.
• Pregnant or nursing.
• Substance abuse.
• Psychiatric problems or unrealistic expectations.
• Severe bruxism or clenching.
• Immunosuppressed or immunocompromised.
• Treated or under treatment with intravenous amino-bisphosphonates.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (2)

• Ottoni JM, Oliveira ZF, Mansini R, Cabral AM. Correlation between placement torque and survival of single-tooth implants. Int J Oral Maxillofac Implants. 2005 Sep-Oct;20(5):769-76.

  PMID: 16274152 BACKGROUND

• Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162.

  PMID: 8055503 BACKGROUND

Related Links

• Clinical and radiographic evaluation of osseodensification versus osteotome for sinus floor elevation in partially atrophic maxilla: A prospective long term study
• Primary Stability of Implant in Closed Sinus Lifting Cases Using Densah Bur Versus Osteotome
• Patient Perception and Radiographic Assessment of Sinus Lifting Procedure using Densah Bur versus Osteotome-mediated sinus lifting: A Randomized Clinical Trial

Central Study Contacts

Eman M Anwar, Professor

CONTACT

+20223642705; rec@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This trial is considered a randomized double blind clinical trial due to the following: 1. The participant will be blinded to the technique that will be used during the surgical operation. 2. The outcome assessor will be blinded 3. The operator (DR.B.S.) will not be blinded for both techniques during the surgical operation, as the two techniques are different. (Dr. M.O.). The purpose of double blinding procedure is to reduce assessment bias and to increase accuracy and objectivity of clinical outcomes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Dental Surgery

Model Details: Patients' data will be enrolled in database of the Outpatient clinics of the Department of Oral and maxillofacial surgery, Faculty of Dentistry, Cairo University. If there is a potential eligibility, the patient will be examined thoroughly as described before. Consecutive sampling is done through screening of patients. This will continue until the target population is achieved. Identifying and recruiting potential subjects is achieved through patient database.

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: August 24, 2022
• Study Start: September 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share