Dental Implant HealingNCT07715825
Internal Irrigation Surgery
A study testing Irrigation-Integrated Surgical Guide and Conventional Surgical Guide in people with Dental Implant Healing and Partial Edentulism Class 1, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Heat generated during osteotomy and implant placement may cause thermal injury to bone and adversely affect healing and osseointegration. External irrigation is commonly used to reduce heat generation; however, cooling may be less effective at the drill-bone interface, particularly during guided implant surgery. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Healing, Partial Edentulism Class 1, Partial Edentulism Class II
- What is being tested?
- Irrigation-Integrated Surgical Guide and Conventional Surgical Guide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 25+
- Patients requiring a dental implant in the maxilla or mandible
- Patients with sufficient bone volume for implant placement.
- Patients classified as ASA I or II based on the American Society of Anesthesiologists (ASA) physical status classification system.
- Patients capable of providing informed consent and willing to adhere to study procedures and follow-up appointments.
- Patients with adequate interarch space to accommodate guided implant surgery.
- No history of implant placement at the experimental or control site.
Who cannot join
- ASA class 3 or higher
- Currently undergoing or history of bisphosphonate or antiresorptive therapy
- Patients who have received prior radiation therapy to the head and neck.
- Patients with contraindications for implant placement, such as active infections or severe periodontal disease.
- Pregnant or breastfeeding
- Patients with psychiatric or cognitive conditions impairing informed consent or compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Maryland School of Dentistry
Baltimore, Maryland, 21201
About this study
Official title: Evaluation of an Internal Irrigation Surgical Guide to Reduce Heat Generation During Dental Implant Surgery
Heat generated during osteotomy and implant placement may cause thermal injury to bone and adversely affect healing and osseointegration. External irrigation is commonly used to reduce heat generation; however, cooling may be less effective at the drill-bone interface, particularly during guided implant surgery.
Surgical guides with integrated irrigation channels have been developed to deliver coolant more directly to the osteotomy site, but clinical evidence regarding their effectiveness remains limited. This study will evaluate whether an internal irrigation surgical guide system reduces heat generation during osteotomy compared with a conventional guided implant surgery approach. The study will also assess clinical outcomes associated with implant placement. The findings may help inform safer and more effective protocols for guided dental implant surgery.
Read the detailed description
Heat generation during osteotomy and implant placement is a critical concern in implant dentistry, as excessive temperatures can lead to bone necrosis, impaired healing, and early implant failure. A temperature increase of 10°C can be considered a threshold for potential issues. Bone cell damage can occur if the temperature reaches 47°C.3 A temperature of 47°C for 1 minute can impair implant osseointegration. The current standard of care involves the use of external irrigation to reduce heat generation during the drilling process. However, this method has limitations including poor visibility of surgical site, uneven cooling at the drill-bone interface, and inability to directly cool in guided surgery.
To address these concerns, recent innovations include surgical guides with integrated irrigation channels, which direct cooling fluid more efficiently to the drilling site and may reduce the risk of heat-induced bone injury. However, clinical evidence supporting the superiority of these advanced irrigation guides over traditional designs is still limited, highlighting the need for further research to optimize both surgical safety and outcomes.
This study aims to evaluate the effectiveness of an internal irrigation surgical guide system in reducing heat generation during osteotomy and improving outcomes of dental implant surgery. The findings from this study could inform clinical practice and contribute to the development of safer, more effective implant placement protocols.
- Conditions
- Dental Implant Healing, Partial Edentulism Class 1, Partial Edentulism Class II, Partial Edentulism Class 3
- Being tested
- Irrigation-Integrated Surgical Guide, Conventional Surgical Guide
- Keywords
- dental implant surgery, dental implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigation-Integrated Surgical GuideDevice
Guided implant osteotomy using a surgical guide with an integrated irrigation channel for delivery of sterile saline to the osteotomy site.
Conventional Surgical GuideDevice
Conventional guided implant osteotomy using external sterile saline irrigation.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Surgical Guide With External Irrigation | Active comparator | Implant osteotomy and implant placement will be performed using a conventional surgical guide with standard external sterile saline irrigation. Receives: Device: Conventional Surgical Guide |
| Irrigation-Integrated Surgical Guide | Experimental | Implant osteotomy and implant placement will be performed using a surgical guide incorporating an internal irrigation channel designed to direct sterile saline to the drill-bone interface. Receives: Device: Irrigation-Integrated Surgical Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Implant Failure
Number and percentage of dental implants demonstrating clinical mobility or implant loss before prosthetic loading.
Measured: From implant placement through 6 months postoperatively
Secondary outcomes (4)
Early Marginal Bone Level Change
Change in marginal bone level measured on standardized periapical radiographs relative to the implant platform.
Measured: Implant placement, approximately 3 months postoperatively, and 6 months postoperatively
Peri-implant Radiolucency
Presence or absence of radiographic radiolucency surrounding the dental implant.
Measured: Through 6 months postoperatively
Persistent Peri-implant Pain or Suppuration
Number and percentage of implant sites demonstrating persistent pain or suppuration during postoperative follow-up.
Measured: Through 6 months postoperatively
Clinician-Reported Ease of Use
Clinician assessment of the ease of use, procedural efficiency, and perceived clinical benefit of the assigned surgical guide using a study-specific postoperative questionnaire. Each item is rated on a 5-point Likert scale ranging from 1 to 5, with higher scores indicating greater ease of use, efficiency, or perceived benefit.
Measured: Immediately after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radi Masri, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715825
- Sponsor's protocol ID
- HP-00119624
- Status last verified
- Aug 2026
- First submitted
- 16 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Internal Irrigation Surgical Guide to Reduce Heat Generation During Dental Implant Surgery
- ClinicalTrials.gov ID
- NCT07715825
- Acronym / sponsor ID
- HP-00119624
- Conditions
- Dental Implant Healing, Partial Edentulism Class 1, Partial Edentulism Class II, Partial Edentulism Class 3
- Keywords
- dental implant surgery, dental implant placement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heat generated during osteotomy and implant placement may cause thermal injury to bone and adversely affect healing and osseointegration. External irrigation is commonly used to reduce heat generation; however, cooling may be less effective at the drill-bone interface, particularly during guided implant surgery.
Surgical guides with integrated irrigation channels have been developed to deliver coolant more directly to the osteotomy site, but clinical evidence regarding their effectiveness remains limited. This study will evaluate whether an internal irrigation surgical guide system reduces heat generation during osteotomy compared with a conventional guided implant surgery approach. The study will also assess clinical outcomes associated with implant placement. The findings may help inform safer and more effective protocols for guided dental implant surgery.
Detailed description
Heat generation during osteotomy and implant placement is a critical concern in implant dentistry, as excessive temperatures can lead to bone necrosis, impaired healing, and early implant failure. A temperature increase of 10°C can be considered a threshold for potential issues. Bone cell damage can occur if the temperature reaches 47°C.3 A temperature of 47°C for 1 minute can impair implant osseointegration. The current standard of care involves the use of external irrigation to reduce heat generation during the drilling process. However, this method has limitations including poor visibility of surgical site, uneven cooling at the drill-bone interface, and inability to directly cool in guided surgery.
To address these concerns, recent innovations include surgical guides with integrated irrigation channels, which direct cooling fluid more efficiently to the drilling site and may reduce the risk of heat-induced bone injury. However, clinical evidence supporting the superiority of these advanced irrigation guides over traditional designs is still limited, highlighting the need for further research to optimize both surgical safety and outcomes.
This study aims to evaluate the effectiveness of an internal irrigation surgical guide system in reducing heat generation during osteotomy and improving outcomes of dental implant surgery. The findings from this study could inform clinical practice and contribute to the development of safer, more effective implant placement protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Surgical Guide With External Irrigation | Active comparator | Device: Conventional Surgical GuideImplant osteotomy and implant placement will be performed using a conventional surgical guide with standard external sterile saline irrigation. |
| Irrigation-Integrated Surgical Guide | Experimental | Device: Irrigation-Integrated Surgical GuideImplant osteotomy and implant placement will be performed using a surgical guide incorporating an internal irrigation channel designed to direct sterile saline to the drill-bone interface. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 25+
- Patients requiring a dental implant in the maxilla or mandible
- Patients with sufficient bone volume for implant placement.
- Patients classified as ASA I or II based on the American Society of Anesthesiologists (ASA) physical status classification system.
- Patients capable of providing informed consent and willing to adhere to study procedures and follow-up appointments.
Key exclusion criteria (6 listed)
- ASA class 3 or higher
- Currently undergoing or history of bisphosphonate or antiresorptive therapy
- Patients who have received prior radiation therapy to the head and neck.
- Patients with contraindications for implant placement, such as active infections or severe periodontal disease.
- Pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irrigation-Integrated Surgical GuideGuided implant osteotomy using a surgical guide with an integrated irrigation channel for delivery of sterile saline to the osteotomy site. | Device | Irrigation-Integrated Surgical Guide |
| Conventional Surgical GuideConventional guided implant osteotomy using external sterile saline irrigation. | Device | Conventional Surgical Guide With External Irrigation |
Primary outcome
Early Implant Failure
Time frame: From implant placement through 6 months postoperatively
Number and percentage of dental implants demonstrating clinical mobility or implant loss before prosthetic loading.
4 secondary outcomes
Early Marginal Bone Level Change
Time frame: Implant placement, approximately 3 months postoperatively, and 6 months postoperatively
Peri-implant Radiolucency
Time frame: Through 6 months postoperatively
Persistent Peri-implant Pain or Suppuration
Time frame: Through 6 months postoperatively
Clinician-Reported Ease of Use
Time frame: Immediately after implant placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrigation-Integrated Surgical Guide and Conventional Surgical Guide in people with Dental Implant Healing and Partial Edentulism Class 1, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radi Masri (410 706 8133, rmasri@umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Implant Failure (time frame: From implant placement through 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.