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NCT Number: NCT06992557

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

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?

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Key information

Conditions

Implant Stability Low Speed Drilling

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university , faculty of dentistry

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biological drilling osteotomy protocol

Procedure
  • 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
  • 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.

Primary outcomes

  1. Implant stability (Implant Stability Quotient )

    Time frame: 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 outcomes

  1. Crestal bone level changes

    Time frame: 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.

  2. Post-Operative Pain ( visual analogue scale)

    Time frame: 7 days post surgically

    Filled in by the patient after being given instructions about charting by the dental operator

  3. Post-operative swelling (Verbal rating scale)

    Time frame: 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).

  4. Post-Operative patient's Satisfaction

    Time frame: 3 months post surgically

    Three Yes or No Questions will be asked to the patient about his overall satisfaction about the procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Mazen Mostafa, master in periodontology

CONTACT

[email protected]

00201005305913

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 28, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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