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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05513170

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Edentulous Alveolar Ridge	Procedure: Use of Densah Burs in closed sinus lift Procedure: Closed sinus lift using osteotomes	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Double (Participant, Outcomes 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

Primary Purpose:

Treatment

Official Title:

Graftless Closed Sinus Tenting Using Dental Implants After Densah Burs Osteotomy Versus Conventional Osteotomy in Localized Sinus Pneumatization: a Randomized Clinical Trial

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Closed sinus lift using Densah bur Closed sinus lifting will be performed using densah burs and then dental implants will be placed.	Procedure: Closed sinus lift using osteotomes Closed sinus lift will be performed using osteotomes. Osteotomes elevate the sinus floor and enhance the bone quality.
Active Comparator: Conventional closed sinus lift using osteotomes Sinus lifting will be performed using osteotomes and then dental implants will be placed.	Procedure: Use of Densah Burs in closed sinus lift 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.

Arm

Intervention/Treatment

Active Comparator: Closed sinus lift using Densah bur

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

Procedure: Closed sinus lift using osteotomes

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

Active Comparator: Conventional closed sinus lift using osteotomes

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

Procedure: Use of Densah Burs in closed sinus lift

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.

Outcome Measures

Primary Outcome Measures

Measurement of Bone Change in Cone Beam CT [three and six months]
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) [At the day of implant placement and after six months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:

Basma Mohamed Abdelfatah Mohamed Shaheen, Doctor of Dental Surgery, Cairo University

ClinicalTrials.gov Identifier:

NCT05513170

Other Study ID Numbers:

Densah Burs

First Posted:

Aug 24, 2022

Last Update Posted:

Aug 24, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Basma Mohamed Abdelfatah Mohamed Shaheen, Doctor of Dental Surgery, Cairo University

Additional relevant MeSH terms:

Mouth, Edentulous

Study Results

No Results Posted as of Aug 24, 2022