Mandibular Biological Drilling at Different Speeds for Dental Implant Placement

Официальное название

Radiographic Assessment of Mandibular Biological Drilling at Different Drilling Speeds: A Randomized Clinical Trial

Обзор

This randomized controlled clinical trial aims to evaluate the effect of different biological drilling speeds (50, 150, and 300 rpm) during implant osteotomy preparation in the mandible on marginal bone level changes and implant stability. Thirty-nine patients requiring a single dental implant in the mandible will be randomly allocated into three groups according to drilling speed. All implants will be placed using a biological drilling protocol without irrigation. Implant stability will be measured using resonance frequency analysis at implant placement and follow-up visits. Marginal bone levels will be evaluated radiographically using standardized periapical radiographs during the follow-up period up to 12 months. The study aims to determine whether different low-speed drilling protocols influence peri-implant bone remodeling and implant stability.

Подробное описание

This randomized parallel-group clinical trial will investigate the influence of different biological drilling speeds on radiographic marginal bone level changes and implant stability in mandibular dental implant placement.

Thirty-nine partially edentulous adult patients requiring a single implant in the mandible will be recruited from the outpatient clinic of the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University. Eligible participants will be randomly assigned to one of three groups according to drilling speed used during osteotomy preparation: 50 rpm, 150 rpm, or 300 rpm.

Implant site preparation will be performed using the same sequential drilling protocol and implant system in all groups. Biological drilling will be performed without irrigation, with careful control of drilling pressure and intermittent drilling to minimize thermal trauma.

Implant stability will be measured using resonance frequency analysis (RFA) at implant placement and during follow-up visits. Radiographic assessment of marginal bone levels will be conducted using standardized periapical radiographs obtained using the paralleling technique. Radiographic measurements will be performed at baseline and during follow-up visits up to 12 months.

The primary outcome of the study will be marginal bone level changes measured radiographically in millimeters. The secondary outcome will be implant stability expressed as Implant Stability Quotient (ISQ) values.

The results of this study may help identify the optimal biological drilling speed that preserves bone vitality while maintaining adequate implant stability and favorable peri-implant bone remodeling.

Вмешательства

• Процедура biological drilling at 50 RPM
  Biological drilling (no irrigation) at 50 rpm for all sequential drills.
• Процедура biological drilling at 150 RPM
  Biological drilling (no irrigation) at 150 rpm for all sequential drills.
• Процедура biological drilling at 300 RPM
  Biological drilling (no irrigation) at 300 rpm for all sequential drills.

Первичные конечные точки

• Marginal Bone Level Change [Срок оценки: Baseline (Surgery) and 12 months postoperatively.]

Вторичные конечные точки (1)

• Implant Stability [Срок оценки: At time of insertion and 3 months postoperatively.]

Критерии участия

Критерии включения

• Adult patients aged 20-60 years.
• Partially edentulous patients requiring a single dental implant in the mandible.
• Adequate bone height and width at the implant site to accommodate the planned implant dimensions without the need for advanced grafting.
• Good oral hygiene (full-mouth plaque and bleeding scores within acceptable limits).
• Patients willing to participate, available for 12-month follow-up, and able to sign informed consent.

Критерии исключения

• Systemic diseases or conditions that may compromise bone healing (e.g. uncontrolled diabetes, immunosuppression, recent radiotherapy in head and neck region).
• Smoking more than 10 cigarettes/day or heavy vaping.
• Pregnant or lactating women.
• History of bisphosphonate or other anti-resorptive therapy affecting bone metabolism.
• Active periodontal disease or poor oral hygiene.
• Acute infection or pathology at the planned implant site.
• Need for simultaneous major bone grafting at the same site.
• Bruxism or severe parafunctional habits.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Abdel Motagly, M., El Khadem, A. and Abdel Rassoul, M.A. (2021) Assessment of low-speed drilling without irrigation versus conventional drilling with irrigation regarding heat generation and peri-implant marginal bone loss (randomised clinical trial). Alexandria Dental Journal, 46(2), Article 6, pp. 33-38
• Srivastava S, Srivastava SK, Shekhar A, Chaturvedi A, Sarkar D. A Comparative Evaluation of Marginal Bone Loss Around Dental Implants Using Slow- and Medium-Speed Drilling Without Irrigation Versus High-Speed Drilling With Irrigation: An In Vivo Study. Cureus. 2025 May 24;17(5):e84730. doi: 10.7759/cureus.84730. eCollection 2025 May. PMID 40551940

Идентификаторы

NCT: NCT07474454 · OMFS 3 3 5 8

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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