Clinical trial NCT05513170: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Edentulous Alveolar Ridge
Keywords: Densah Burs
Osteotomes
Sinus Tenting
Graftless
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Measurement of Bone Change in Cone Beam CT
timeFrame: three and six months
Secondary outcomes:
measure: Measurement of Primary and Secondary Implant stability using Resonance Frequency Analysis (RFA)
timeFrame: At the day of implant placement and after six months
Other outcomes:
Locations:
Study officials:
References:
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.
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.