Internal Irrigation Surgery
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Radi Masri
- Telefoonnummer: 410 706 8133
- E-mail: rmasri@umaryland.edu
Studie Contact Back-up
- Naam: Hanae Saito
- Telefoonnummer: 410 706 3646
- E-mail: hsaito@umaryland.edu
Studie Locaties
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21201
- University of Maryland School of Dentistry
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Conventional Surgical Guide With External Irrigation
Implant osteotomy and implant placement will be performed using a conventional surgical guide with standard external sterile saline irrigation.
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Conventional guided implant osteotomy using external sterile saline irrigation.
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Experimenteel: Irrigation-Integrated Surgical Guide
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.
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Guided implant osteotomy using a surgical guide with an integrated irrigation channel for delivery of sterile saline to the osteotomy site.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Early Implant Failure
Tijdsspanne: From implant placement through 6 months postoperatively
|
Number and percentage of dental implants demonstrating clinical mobility or implant loss before prosthetic loading.
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From implant placement through 6 months postoperatively
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Early Marginal Bone Level Change
Tijdsspanne: Implant placement, approximately 3 months postoperatively, and 6 months postoperatively
|
Change in marginal bone level measured on standardized periapical radiographs relative to the implant platform.
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Implant placement, approximately 3 months postoperatively, and 6 months postoperatively
|
|
Peri-implant Radiolucency
Tijdsspanne: Through 6 months postoperatively
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Presence or absence of radiographic radiolucency surrounding the dental implant.
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Through 6 months postoperatively
|
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Persistent Peri-implant Pain or Suppuration
Tijdsspanne: Through 6 months postoperatively
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Number and percentage of implant sites demonstrating persistent pain or suppuration during postoperative follow-up.
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Through 6 months postoperatively
|
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Clinician-Reported Ease of Use
Tijdsspanne: Immediately after implant placement
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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.
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Immediately after implant placement
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- HP-00119624
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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