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

N/ANot Yet RecruitingNCT06992557

Cairo University28 enrolled

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?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Implant Stability Low Speed Drilling

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.

Conventional drilling osteotomy protocolPROCEDURE

* 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

Sex: ALLMin age: 21 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 surgical

Secondary Outcomes

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 surgical

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 surgically

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 surgically

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 surgically