Clinical and Radiographic Evaluation of Implant Stability in Healed Maxillary Posterior Sites Comparing Osteotome, Osseodensification and Conventional Drilling Implant Placement Techniques

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-70
SponsorCairo University

About this trial

This study aims to compare the implant stability values following implant placement via Osteotomes and via Osseodensification using Densah Burs versus implant placement using conventional drilling technique in patients with upper posterior partially edentulous ridges as well as evaluating the crestal bone loss around temporary restorations following the three compared drilling techniques.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with an age range of 25-70 years

Patients with systemic health

Patient with missing teeth in the upper posterior area

Patients with D3 or D4 type of alveolar bone

Disqualifiers

Pregnant females

Smokers

Patients with habits that may compromise the longevity and affect the result of the implant as alcoholism or parafunctional habits

History of radiotherapy or use of bisphosphonates

Trial design

Design model

Parallel

Treatments tested in this trial

  • Densah Burs

    Other intervention

    Series of drilling burs inserted in the osteotomy with special design that have a large negative rake angle flute, a cutting chisel edge and a tapered shank, so as they enter deeper into the osteotomy and they have a progressively increasing diameter that controls the expansion process. These burs are used with a standard surgical engine and can densify bone by rotating in the noncutting direction (counterclockwise at 800-1,200 rotations per minute) or drill bone by rotating in the cutting direction (clockwise at 800-1,200 rotations per minute) with an in and out movement together with copious saline irrigation and increasing bone plasticity and ability to expand under rate dependent stress.

  • Osteotomes

    Other intervention

    The osteotomes kit are a series of tools that first designed by Summers in 1994. The concept was to maintain the existing bone by compressing trabecular bone laterally and apically with minimal trauma to improve the bone density. The condensed bone in this way will have to put in act a double repairing mechanism, from one side represented by the normal processes of osteointegration and on the other side from the processes of the reparation post fracture like that depends on BMU (bone modelling units) which create new spaces for the new vessels and afterwards filling all the gaps between the bone and the implant.

  • Conventional drilling

    Other intervention

    The implant drilling kit provided by the manufacturer will be used for the implant placement, using the pilot drill followed by consequent drills according to the size of the osteotomy needed.

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: Conventional drilling for implant placementActive comparator 1 intervention
Group B: Implant placement using Densah BursExperimental treatment 1 intervention
Group C: Implant placement using OsteotomesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Implant stability.

ISQ units. (Implant Stability Quotient)

Time frame
Will take place at same day,1,2,3,4,6,8 ,12and 16 weeks postoperatively.

Secondary outcomes

1

Crestal bone loss

Millimeters in standardized periapical radiograph

Time frame
Will be evaluated to determine the initial crestal bone level at day of the surgery as well at 12 and 48 weeks postoperatively.

Other outcomes

1

Patient's pain

Visual Analogue Scale (VAS) on a scale of 0 to 10 where (0) is no pain and (10) is the maximum pain.

Time frame
Same day of surgery as well as 1 week postoperatively.
2

Patient satisfaction

Questionnaire (3 yes or no questions)

Time frame
Same day f surgery as well as 1 and 2 weeks postoperatively.
3

Time spent in surgery

Minutes using stopwatch.

Time frame
Same day of surgery (intraoperatively)
4

Patient's pain

Number of analgesic tablets.

Time frame
Same day of surgery as well as 1 week postoperatively.

Sponsors and contacts

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