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NCT Number: NCT06599112

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

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.

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Key information

Conditions

Implant Stability

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Giza, Egypt

Location status: Recruiting

Location contact

Cairo University

CONTACT

0223642705

Nadine Yehia Mohamed, Bachelor's degree

PRINCIPAL_INVESTIGATOR

About this study

  • Patients with partially edentulous ridges seeking restoration of their missing teeth, with enough measurements for implant placement will be recruited from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry-Cairo University to participate in this study and will be randomized to be either undergoing conventional drilling according to the manufacturer's instructions (control group) or either one of the two intervention groups; Intervention group (A) where implant placement will be done using the Osseodensification technique by the Densah burs or Intervention group (B) where the implant placement will be done using the Osteotomes.
  • Neobiotech IS III active implants will be used in this study, they have an osseoconductive SLA-coated surface, a tapered design with a crestal macrothread design (0.8 pitch), a self compactable apex as well as deep thread to maximize implant stability. The implant has a platform switching feature and a conical/hex design.
  • A temporary PMMA crown after 3 months from implant placement and will be kept for follow up for a year then definitive final restoration will be made.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Healed bony sites with sufficient dimension for implant placement
  • Vertical height (≥ 10 mm)
  • Bucco-lingual dimension (≥ 5.5 mm)
  • Mesio-distal width (≥6.5 mm)
  • Patients with periodontal health (PD < 4mm, BOP < 10%)
  • Inter-arch space of 7.5 to allow implant restoration
  • Good oral hygiene
  • Cooperative patients who accepted the trial follow up period and sign the informed consent

Exclusion criteria

  • 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

Treatment and study plan

Densah Burs

Other

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

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

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.

Primary outcomes

  1. Implant stability.

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

    ISQ units. (Implant Stability Quotient)

Secondary outcomes

  1. Crestal bone loss

    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.

    Millimeters in standardized periapical radiograph

Other outcomes

  1. Patient's pain

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

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

  2. Patient satisfaction

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

    Questionnaire (3 yes or no questions)

  3. Time spent in surgery

    Time frame: Same day of surgery (intraoperatively)

    Minutes using stopwatch.

  4. Patient's pain

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

    Number of analgesic tablets.

Study contacts

Contact information is provided by the study sponsor or research team.

Nadine Yehia Mohamed, Bachelor's degree

CONTACT

[email protected]

01019885817

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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