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

Not Applicable

Not yet recruiting

• Conditions: Implant Stability; Low Speed Drilling

• Registration Number: NCT06992557
• Lead Sponsor: Cairo University

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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28
• Study Start: 2025-06
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Implant stability (Implant Stability Quotient )	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 Outcome Measures

Name	Time	Method
Crestal bone level changes	Measurements will be taken immediately post surgical and after 3 months post surgical	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.
Post-Operative Pain ( visual analogue scale)	7 days post surgically	Filled 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 surgically	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).
Post-Operative patient's Satisfaction	3 months post surgically	Three Yes or No Questions will be asked to the patient about his overall satisfaction about the procedure

Trial Locations

Locations (1)

Cairo university , faculty of dentistry; 🇪🇬 Cairo, Egypt