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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06992557
Enrollment
28
Registered
2025-05-28
Start date
2025-06-30
Completion date
2026-01-31
Last updated
2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implant Stability, Low Speed Drilling

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?

Interventions

PROCEDUREBiological 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.

PROCEDUREConventional 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Implant stability (Implant Stability Quotient )Measurements will be taken immediately post surgical ,3 weeks,2 month and 3 months post surgicalScale ranges from 1 to 100, the higher the Implant stability quotient the more stability

Secondary

MeasureTime frameDescription
Crestal bone level changesMeasurements will be taken immediately post surgical and after 3 months post surgicalLong-cone intraoral radiographs were collected under controlled circumstances with personalised X-ray holders (XPC) and a registration bite block for repeatable imaging. The periapical radiographs carried out by digital sensor size 2 standardized film and standardized exposure settings The neck of the implant was taken as a reference point in all images for standardization post surgically and after 3 months.
Post-Operative Pain ( visual analogue scale)7 days post surgicallyFilled in by the patient after being given instructions about charting by the dental operator
Post-operative swelling (Verbal rating scale)Swelling will be assessed 7 days post surgicallyFilled in by the patient after being given instructions about charting by the dental operator. * Absent(no swelling) * Slight (intraoral swelling at the operated area) * Moderate (moderate intraoral swelling at the operated area) * Intense (intensive extra oral swelling extending beyond the operated area).
Post-Operative patient's Satisfaction3 months post surgicallyThree Yes or No Questions will be asked to the patient about his overall satisfaction about the procedure

Countries

Egypt

Contacts

Primary ContactMazen Mostafa, master in periodontology
mazen.ali@dentistry.cu.edu.eg00201005305913

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026