Bone Graft Clinical Trials

Clinical trials related to Bone Graft Procedure

Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants Using the Polymerase Chain Reaction Method

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this prospective clinical study is to evaluate and compare the effectiveness of different cleaning (decontamination) methods for dental implants affected by peri-implantitis. Peri-implantitis is an inflammatory condition caused by a bacterial biofilm on the implant surface, which can lead to bone loss and implant failure if left untreated. Because the rough surface and threads of implants make them difficult to clean, finding the most effective decontamination method is critical for saving the implant. This study will include 90 healthy, non-smoking participants who have a bone-level dental implant affected by peri-implantitis without vertical bone loss. Participants will be randomly assigned to one of three treatment groups (30 implants per group) to undergo a specific decontamination procedure during their surgical treatment: Group 1 (Laser PDT): Decontamination using photodynamic therapy with a blue laser and riboflavin, followed by a sterile saline rinse. Group 2 (GalvoSurge): Decontamination using an electrolytic cleaning device, followed by a sterile saline rinse. Group 3 (Active Control): Decontamination using a 0.2% chlorhexidine gluconate rinse, which is the current standard of care. To measure the effectiveness of these treatments, researchers will take sterile swabs from the implant surface immediately before and after the decontamination process. These swabs will be analyzed using PCR to detect changes in the microbiological load of five specific bacteria known to cause gum and implant disease (Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Treponema denticola, and Tannerella forsythia). Following the decontamination and swabbing, all participants will receive a standard Guided Bone Regeneration (GBR) procedure using autogenous bone, a xenograft, and a collagen membrane to help rebuild the bone around the implant. By comparing the microbiological results before and after treatment, the study aims to determine whether the newer methods (Laser PDT or electrolytic cleaning) are more effective at removing harmful bacteria than the traditional chlorhexidine rinse prior to bone regeneration.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Patients presenting with at least one bone-level dental implant affected by peri-implantitis.

• The affected implant must be deemed viable with a perspective for preservation/retention in the dental arch.

• Patients must be non-smokers.

• Patients in good general health, classified as ASA I (a normal healthy patient) or ASA II (a patient with mild systemic disease) according to the American Society of Anesthesiologists physical status classification system.

Locations
Other Locations
Croatia
School of Dental Medicine
RECRUITING
Zagreb
Contact Information
Primary
Igor Smojver, DMD;PhD
ismojver@sfzg.hr
385981651932
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 90
Treatments
Experimental: Laser PDT + Saline Rinse
Implants in this group will undergo surface decontamination using Photodynamic Therapy (PDT). This involves the application of a riboflavin photosensitizer activated by a blue laser, followed by a rinse with sterile normal saline solution. The decontamination is performed immediately after the baseline microbiological swab (Sample 1) and before the post-treatment swab (Sample 2). All implants will subsequently receive a standard Guided Bone Regeneration (GBR) procedure.~Interventions:~Device / Procedure: Laser Photodynamic Therapy (PDT)~Procedure: Guided Bone Regeneration (GBR)
Experimental: GalvoSurge + Saline Rinse
Implants in this group will undergo surface decontamination using the GalvoSurge electrolytic cleaning system, followed by a rinse with sterile normal saline solution. The decontamination is performed immediately after the baseline microbiological swab (Sample 1) and before the post-treatment swab (Sample 2). All implants will subsequently receive a standard Guided Bone Regeneration (GBR) procedure.~Interventions:~Device / Procedure: GalvoSurge Electrolytic Cleaning~Procedure: Guided Bone Regeneration (GBR)
Active_comparator: Chlorhexidine Rinse (Control)
Implants in this control group will undergo surface decontamination using the current clinical gold standard, which is a 0.2% chlorhexidine gluconate rinse. The decontamination is performed immediately after the baseline microbiological swab (Sample 1) and before the post-treatment swab (Sample 2). All implants will subsequently receive a standard Guided Bone Regeneration (GBR) procedure.~Interventions:~Drug / Procedure: 0.2% Chlorhexidine Gluconate Rinse~Procedure: Guided Bone Regeneration (GBR)
Related Therapeutic Areas
Sponsors
Leads: University of Zagreb

This content was sourced from clinicaltrials.gov