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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Edentulous Alveolar Ridge
• Intervention / Treatment: Procedure: Closed sinus lift using osteotomes; Procedure: Use of Densah Burs in closed sinus lift

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eman M Anwar, Professor; Phone Number: 522 +20223642705; Email: rec@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the day of implant placement and after six months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

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

Helpful 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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2022
• Primary Completion (ANTICIPATED): October 1, 2023
• Study Completion (ANTICIPATED): November 1, 2023

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: August 20, 2022
• First Posted (ACTUAL): August 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 20, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Densah Burs; Osteotomes; Sinus Tenting; Graftless
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: Densah Burs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No