Clinical trial NCT06599112: Clinical and Radiographic Evaluation of Implant Stability in Healed Maxillary Posterior Sites Comparing Osteotome, Osseodensification and Conventional Drilling Implant Placement Techniques
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Implant Stability
Keywords: Dental implant placement
Osseodensification
Osteotomes
Implant stability
Crestal bone loss
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups. Control Group Intervention group (A) Intervention group (B)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: * 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.

Eligibility criteria: 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

Primary outcomes:
measure: Implant stability.
timeFrame: Will take place at same day,1,2,3,4,6,8 ,12and 16 weeks postoperatively.
Secondary outcomes:
measure: Crestal bone loss
timeFrame: 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:
measure: Patient's pain
timeFrame: Same day of surgery as well as 1 week postoperatively.
measure: Patient satisfaction
timeFrame: Same day f surgery as well as 1 and 2 weeks postoperatively.
measure: Time spent in surgery
timeFrame: Same day of surgery (intraoperatively)
measure: Patient's pain
timeFrame: Same day of surgery as well as 1 week postoperatively.
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
References: