Menu
Not yet recruiting NCT06992557

Clinical Evaluation of Biological Drilling Osteotomy Protocol Versus Conventional Drilling Osteotomy Protocol

No phase Interventional Implant Stability Low Speed Drilling

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biological drilling osteotomy protocol, Conventional drilling osteotomy protocol.
Who it may be relevant to
Registry conditions: Implant Stability, Low Speed Drilling. Basic parameters: 21 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Clinical Evaluation of Biological Drilling Osteotomy Protocol Versus Conventional Drilling Osteotomy Protocol in the Mandibular Posterior Area a Randomized Controlled Trial

Overview

This study aims to evaluate the effect of biological drilling osteotomy protocol compared to conventional osteotomy protocol in delayed implant placement in the posterior mandible regarding implant stability Type of study design: Randomized Clinical Trial In patient indicated for delayed implant placement in the lower posterior mandible will the use of biological drilling protocol osteotomy compared to conventional drilling protocol osteotomy differ regarding implant stability at three months?

Interventions

  • Procedure Biological drilling osteotomy protocol
    * Osteotomy site preparation through sequential biologic drilling in healed bony site with a pilot drill at 800 rpm with irrigation initiates the drilling process, which is then followed by drills of different sizes and shapes at low speeds at 150rpm without irrigation. * The implant will be positioned in the osteotomy site and a healing collar will be placed.
  • Procedure Conventional drilling osteotomy protocol
    * Preparation for osteotomy site with conventional sequential drilling in healed bony site at 1200 rpm with irrigation. * The implant will be positioned in the osteotomy site and a healing collar will be placed.

Primary outcome measures

  • Implant stability (Implant Stability Quotient ) [Time frame: Measurements will be taken immediately post surgical ,3 weeks,2 month and 3 months post surgical]
Secondary outcome measures (4)
  • Crestal bone level changes [Time frame: Measurements will be taken immediately post surgical and after 3 months post surgical]
  • Post-Operative Pain ( visual analogue scale) [Time frame: 7 days post surgically]
  • Post-operative swelling (Verbal rating scale) [Time frame: Swelling will be assessed 7 days post surgically]
  • Post-Operative patient's Satisfaction [Time frame: 3 months post surgically]

Eligibility criteria

Inclusion criteria

  • Systemically healthy male and female patients, aged 21 to 60 years old,
  • Indicated for delayed implant placement in the posterior mandibular arch.
  • Good oral health.
  • Willingness to sign the informed consent form.

Exclusion criteria

  • Heavy smoker (> 10 cigarettes/day)
  • Pregnant females
  • Contraindication for Implant surgery.
  • Patients with poor oral hygiene.
  • A history of radiotherapy in the head or neck region.
  • Patients with systemic disease like uncontrolled diabetes mellitus, coagulation disorders, alcohol or drug abuse not suitable for implantation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo university , faculty of dentistry — Cairo

Identifiers

NCT: NCT06992557 · mazenmostafasayedali@@15121987

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗