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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biological drilling at 50 RPM | Procedure | Biological drilling (no irrigation) at 50 rpm for all sequential drills. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Stability | Measured via Resonance Frequency Analysis (RFA) to obtain Implant Stability Quotient (ISQ) values. | At time of insertion and 3 months postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 40551940 | 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. |
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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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.
| biological drilling at 150 RPM | Procedure | Biological drilling (no irrigation) at 150 rpm for all sequential drills. |
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| biological drilling at 300 RPM | Procedure | Biological drilling (no irrigation) at 300 rpm for all sequential drills. |
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