Mandibular Biological Drilling at Different Speeds for Dental Implant Placement

ConditionsEdentulism Tooth Loss

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age20-60

SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

biological drilling at 50 RPM
Procedure/Surgery
Biological drilling (no irrigation) at 50 rpm for all sequential drills.
biological drilling at 150 RPM
Procedure/Surgery
Biological drilling (no irrigation) at 150 rpm for all sequential drills.
biological drilling at 300 RPM
Procedure/Surgery
Biological drilling (no irrigation) at 300 rpm for all sequential drills.

Treatment groups

39 Participants

are divided into 3 treatment groups

Group A: Biological drilling at 50 rpmExperimental treatment 1 intervention

Group B: Biological drilling at 150 rpmExperimental treatment 1 intervention

Group C: Biological drilling at 300 rpmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Marginal Bone Level Change

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

Time frame

Baseline (Surgery) and 12 months postoperatively.

Secondary outcomes

Implant Stability

Measured via Resonance Frequency Analysis (RFA) to obtain Implant Stability Quotient (ISQ) values.

Time frame

At time of insertion and 3 months postoperatively.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: