Clinical Evaluation of Biological Drilling Osteotomy Protocol Versus Conventional Drilling Osteotomy Protocol
1 other identifier
interventional
28
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2025
CompletedFirst Posted
Study publicly available on registry
May 28, 2025
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedMay 28, 2025
May 1, 2025
7 months
May 12, 2025
May 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Implant stability (Implant Stability Quotient )
Scale ranges from 1 to 100, the higher the Implant stability quotient the more stability
Measurements will be taken immediately post surgical ,3 weeks,2 month and 3 months post surgical
Secondary Outcomes (4)
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
Study Arms (2)
Biological drilling osteotomy protocol
EXPERIMENTAL* 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
Conventional drilling osteotomy protocol
ACTIVE COMPARATOR* 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.
Interventions
* 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.
* 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo university , faculty of dentistry
Cairo, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer in The General Organization for Teaching Hospitals and Institutes
Study Record Dates
First Submitted
May 12, 2025
First Posted
May 28, 2025
Study Start
June 1, 2025
Primary Completion
January 1, 2026
Study Completion
January 1, 2026
Last Updated
May 28, 2025
Record last verified: 2025-05