Clinical Evaluation of Biological Drilling Osteotomy Protocol Versus Conventional Drilling Osteotomy Protocol in the Mandibular Posterior Area a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Implant stability (Implant Stability Quotient )
Study Overview
Brief Summary
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?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Biological drilling osteotomy protocol
- Local infiltration anesthesia will be applied to all the patients participating in this study.
- Full thickness mucoperiosteal flap reflection with 15c blade.
- 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.
- The mucoperiosteal flap will be sutured in an interrupted manner with 5-0 proline suture material
Intervention: Biological drilling osteotomy protocol (Procedure)
Conventional drilling osteotomy protocol
- Local infiltration anesthesia will be applied to all the patients participating in this study.
- Full thickness mucoperiosteal flap reflection with 15c blade.
- 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.
- The mucoperiosteal flap will be sutured in an interrupted manner with 5-0 proline suture material.
Intervention: Conventional drilling osteotomy protocol (Procedure)
Outcomes
Primary Outcomes
Implant stability (Implant Stability Quotient )
Time Frame: Measurements will be taken immediately post surgical ,3 weeks,2 month and 3 months post surgical
Scale ranges from 1 to 100, the higher the Implant stability quotient the more stability
Secondary Outcomes
- Crestal bone level changes(Measurements will be taken immediately post surgical and after 3 months post surgical)
- Post-Operative Pain ( visual analogue scale)(7 days post surgically)
- Post-operative swelling (Verbal rating scale)(Swelling will be assessed 7 days post surgically)
- Post-Operative patient's Satisfaction(3 months post surgically)
Investigators
Mazen Mostafa Sayed
Assistant lecturer in The General Organization for Teaching Hospitals and Institutes
Cairo University