Closed Sinus Tenting Using Densah Burs Osteotomy Versus Conventional Osteotomy in Localized Pneumatization
Primary Purpose
Edentulous Alveolar Ridge
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Use of Densah Burs in closed sinus lift
Closed sinus lift using osteotomes
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous Alveolar Ridge focused on measuring Densah Burs, Osteotomes, Sinus Tenting, Graftless
Eligibility Criteria
Inclusion Criteria:
- No inflamed sinus
- Minimum alveolar ridge height 5-6 mm
- Medical free
- Both genders males and females.
Exclusion Criteria:
- Remaining alveolar ridge height is less than 5mm
Patients should not have taken drugs, especially bisphosphonates or drugs altering bone metabolism, within 2 months before the inclusion in the study.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Closed sinus lift using Densah bur
Conventional closed sinus lift using osteotomes
Arm Description
Closed sinus lifting will be performed using densah burs and then dental implants will be placed.
Sinus lifting will be performed using osteotomes and then dental implants will be placed.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Measurement of Primary and Secondary Implant stability using Resonance Frequency Analysis (RFA)
The implant stability quotient (ISQ) of the implants will be measured using a resonance frequency analysis measuring device, that is, Ostell, at the time of placement, which is the primary stability, and after six months, which is the secondary stability. The implant stability quotient has a scale ranging from 0 to 100 in which 0 is a failed implant and 100 is maximum implant stability.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05513170
Brief Title
Closed Sinus Tenting Using Densah Burs Osteotomy Versus Conventional Osteotomy in Localized Pneumatization
Official Title
Graftless Closed Sinus Tenting Using Dental Implants After Densah Burs Osteotomy Versus Conventional Osteotomy in Localized Sinus Pneumatization: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
The rehabilitation of the edentulous posterior maxilla using osseointegrated implants is often challenging due alveolar bone resorption, low bone density and maxillary sinus pneumatization. Maxillary sinus lift is one of the most common surgical techniques used for increasing the available bone volume to place implants and restore function and esthetics. Trans-crestal approach can be successfully adopted when residual bone height is at least 5 mm. Osteotome sinus floor elevation was first in 1994, and proved to be less invasive, more conservative, less time consuming, and reduces postoperative discomfort to the patient. Moreover, this technique was found to yield predictable results with success rates of at least 95%.
Osseodensification is a new surgical technique of biomechanical bone preparation performed for dental implant placement where bone is compacted and auto grafted into open marrow spaces and osteotomy site walls in outwardly expanding directions. It was reported that osseodensification increases the bone-implant contact, bone density, and primary stability. Moreover, the insertion torque peak is directly related to implant primary stability and host bone density. Furthermore, for every 9.8 N cm of torque increased, a reduction in failure rate of 20% in single-tooth implant restoration was observed.
The objective of this study is to evaluate crestal sinus elevation using osseodensification versus osteotomy clinically and radiographically in terms of marginal bone loss, primary and secondary stability and bone gain around the implant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Alveolar Ridge
Keywords
Densah Burs, Osteotomes, Sinus Tenting, Graftless
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
This trial is considered a randomized double blind clinical trial due to the following:
The participant will be blinded to the technique that will be used during the surgical operation.
The outcome assessor will be blinded
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
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Closed sinus lift using Densah bur
Arm Type
Active Comparator
Arm Description
Closed sinus lifting will be performed using densah burs and then dental implants will be placed.
Arm Title
Conventional closed sinus lift using osteotomes
Arm Type
Active Comparator
Arm Description
Sinus lifting will be performed using osteotomes and then dental implants will be placed.
Intervention Type
Procedure
Intervention Name(s)
Use of Densah Burs in closed sinus lift
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Closed sinus lift using osteotomes
Intervention Description
Closed sinus lift will be performed using osteotomes. Osteotomes elevate the sinus floor and enhance the bone quality.
Primary Outcome Measure Information:
Title
Measurement of Bone Change in Cone Beam CT
Description
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.
Time Frame
three and six months
Secondary Outcome Measure Information:
Title
Measurement of Primary and Secondary Implant stability using Resonance Frequency Analysis (RFA)
Description
The implant stability quotient (ISQ) of the implants will be measured using a resonance frequency analysis measuring device, that is, Ostell, at the time of placement, which is the primary stability, and after six months, which is the secondary stability. The implant stability quotient has a scale ranging from 0 to 100 in which 0 is a failed implant and 100 is maximum implant stability.
Time Frame
At the day of implant placement and after six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No inflamed sinus
Minimum alveolar ridge height 5-6 mm
Medical free
Both genders males and females.
Exclusion Criteria:
Remaining alveolar ridge height is less than 5mm
Patients should not have taken drugs, especially bisphosphonates or drugs altering bone metabolism, within 2 months before the inclusion in the study.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eman M Anwar, Professor
Phone
+20223642705
Ext
522
Email
rec@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16274152
Citation
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.
Results Reference
background
PubMed Identifier
8055503
Citation
Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162.
Results Reference
background
Links:
URL
https://edj.journals.ekb.eg/article_71261_ed987b0840ffacb78fc722592cb620ed.pdf
Description
Clinical and radiographic evaluation of osseodensification versus osteotome for sinus floor elevation in partially atrophic maxilla: A prospective long term study
URL
https://clinicaltrials.gov/ct2/show/NCT03559777
Description
Primary Stability of Implant in Closed Sinus Lifting Cases Using Densah Bur Versus Osteotome
URL
https://adjc.journals.ekb.eg/article_165194_0f7e7df22Scb83b2ace99f7d370d885c.pdf
Description
Patient Perception and Radiographic Assessment of Sinus Lifting Procedure using Densah Bur versus Osteotome-mediated sinus lifting: A Randomized Clinical Trial
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Closed Sinus Tenting Using Densah Burs Osteotomy Versus Conventional Osteotomy in Localized Pneumatization
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