Clinical Evaluation of Biological Drilling Osteotomy Protocol Versus Conventional Drilling Osteotomy Protocol
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorCairo University
About this trial
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?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Heavy smoker (> 10 cigarettes/day)
Pregnant females
Contraindication for Implant surgery.
Patients with poor oral hygiene.
Trial design
Design model
Parallel
Treatments tested in this trial
Biological drilling osteotomy protocol
Procedure/Surgery* 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.
Conventional drilling osteotomy protocol
Procedure/Surgery* 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.
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: Biological drilling osteotomy protocolExperimental treatment 1 intervention
Group B: Conventional drilling osteotomy protocolActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Implant stability (Implant Stability Quotient )
Scale ranges from 1 to 100, the higher the Implant stability quotient the more stability
Time frame
Measurements will be taken immediately post surgical ,3 weeks,2 month and 3 months post surgicalSecondary outcomes
1
Crestal bone level changes
Long-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.
Time frame
Measurements will be taken immediately post surgical and after 3 months post surgical2
Post-Operative Pain ( visual analogue scale)
Filled in by the patient after being given instructions about charting by the dental operator
Time frame
7 days post surgically3
Post-operative swelling (Verbal rating scale)
Filled 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).
Time frame
Swelling will be assessed 7 days post surgically4
Post-Operative patient's Satisfaction
Three Yes or No Questions will be asked to the patient about his overall satisfaction about the procedure
Time frame
3 months post surgicallySponsors and contacts
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Source ClinicalTrials.gov
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