Mandibular Biological Drilling at Different Speeds for Dental Implant Placement

NCT07474454 | Not Yet Recruiting DMC

• 1 other identifier: OMFS 3 3 5 8
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Edentulism; Tooth Loss

Keywords

dental implants; biological drilling; low speed drilling; marginal bone loss; implant stability; mandible; randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• Marginal Bone Level Change

  Change in bone level measured from a fixed implant reference point to the crestal bone level using periapical radiographs.

  Baseline (Surgery) and 12 months postoperatively.

Secondary Outcomes (1)

• Implant Stability

  At time of insertion and 3 months postoperatively.

Study Arms (3)

Biological drilling at 50 rpm

EXPERIMENTAL

Participants in this group will undergo dental implant site preparation using a very low-speed "biological" drilling protocol set at 50 rpm. This arm tests the effect of maximal biologic preservation on peri-implant bone maintenance and stability.

Procedure: biological drilling at 50 RPM

Biological drilling at 150 rpm

EXPERIMENTAL

Participants in this group will undergo dental implant site preparation using an intermediate low-speed protocol set at 150 rpm. This arm represents a balance between cutting efficiency and reduced thermal risk

Procedure: biological drilling at 150 RPM

Biological drilling at 300 rpm

EXPERIMENTAL

Participants in this group will undergo dental implant site preparation using a higher low-speed protocol set at 300 rpm. This arm tests whether increasing speed within the "biological" range affects marginal bone remodeling

Procedure: biological drilling at 300 RPM

Interventions

biological drilling at 50 RPM PROCEDURE

Biological drilling (no irrigation) at 50 rpm for all sequential drills.

Biological drilling at 50 rpm

biological drilling at 150 RPM PROCEDURE

Biological drilling (no irrigation) at 150 rpm for all sequential drills.

Biological drilling at 150 rpm

biological drilling at 300 RPM PROCEDURE

Biological drilling (no irrigation) at 300 rpm for all sequential drills.

Biological drilling at 300 rpm

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (2)

• 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

  BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors evaluating radiographic marginal bone levels and implant stability measurements will be blinded to group allocation. The surgeon cannot be blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: March 15, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03