Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants

NCT07529444 | Recruiting

• 1 other identifier: 123456789
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periimplant Diseases; Dental Implant Failure; Dental Implant Complications

Keywords

peri-implantitis; implant decontamination; PDT; electrolytic cleaning; GalvoSurge; Chlorhexidine Gluconate

Outcome Measures

Primary Outcomes (1)

• Change in Microbiological Load of Periodontopathogenic Bacteria

  The primary outcome evaluates the effectiveness of the decontamination protocols by measuring the change in the bacterial load on the implant surface. Sterile swabs taken before and after the intervention are analyzed using a validated real-time Polymerase Chain Reaction (RT-PCR) method to detect five specific periodontopathogenic bacteria (Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Treponema denticola, and Tannerella forsythia). The microbiological load is expressed as a semi-quantitative score (-, +, ++, +++), which is then numerically coded for statistical analysis. The primary measure is the calculated difference (change) between the post-treatment and baseline pre-treatment scores for each individual implant.

  Intraoperatively: Measured immediately before the decontamination procedure (baseline) and immediately after the completion of the decontamination procedure (prior to bone regeneration).

Study Arms (3)

Laser PDT + Saline Rinse

EXPERIMENTAL

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)

Device: Laser Photodynamic Therapy (PDT); Procedure: Guided Bone Regeneration (GBR)

GalvoSurge + Saline Rinse

EXPERIMENTAL

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)

Device: GalvoSurge Electrolytic Cleaning; Procedure: Guided Bone Regeneration (GBR)

Chlorhexidine Rinse (Control)

ACTIVE COMPARATOR

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)

Drug: 0.2% Chlorhexidine Gluconate; Procedure: Guided Bone Regeneration (GBR)

Interventions

GalvoSurge Electrolytic Cleaning DEVICE

Decontamination of the implant surface using the GalvoSurge dental device. This system utilizes an electrolytic process with a specific cleaning solution to actively lift and detach the bacterial biofilm from the rough titanium surface. The procedure is concluded with a sterile normal saline rinse. Arm Group(s): GalvoSurge + Saline Rinse

GalvoSurge + Saline Rinse

Laser Photodynamic Therapy (PDT) DEVICE

Antimicrobial photodynamic therapy applied to the contaminated implant surface. This involves the application of a riboflavin photosensitizer which is then activated by a blue laser to generate reactive oxygen species and eliminate bacterial biofilm. The procedure is concluded with a sterile normal saline rinse. Arm Group(s): Laser PDT + Saline Rinse

Laser PDT + Saline Rinse

0.2% Chlorhexidine Gluconate DRUG

Chemical decontamination of the implant surface by rinsing it thoroughly with a 0.2% chlorhexidine gluconate solution, which serves as the active control/gold standard for antimicrobial reduction. Arm Group(s): Chlorhexidine Rinse (Control)

Chlorhexidine Rinse (Control)

Guided Bone Regeneration (GBR) PROCEDURE

A classic surgical bone grafting procedure performed on all implants immediately following their assigned decontamination protocol. The procedure involves placing a mixture of autologous bone particles and a xenograft around the implant, which is then covered by a collagen membrane fixed in place using titanium pins. Arm Group(s): Laser PDT + Saline Rinse; GalvoSurge + Saline Rinse; Chlorhexidine Rinse (Control)

Chlorhexidine Rinse (Control); GalvoSurge + Saline Rinse; Laser PDT + Saline Rinse

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of vertical bone loss around the affected implant.
• Implants that are not bone-level (e.g., tissue-level implants).
• Patients with any systemic comorbidities.
• Patients who are currently smokers.
• Implants with a poor prognosis that cannot be preserved in the dental arch.

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

School of Dental Medicine

Zagreb, 10000, Croatia

RECRUITING

Related Publications (6)

• Schlee M, Rathe F, Brodbeck U, Ratka C, Weigl P, Zipprich H. Treatment of Peri-implantitis-Electrolytic Cleaning Versus Mechanical and Electrolytic Cleaning-A Randomized Controlled Clinical Trial-Six-Month Results. J Clin Med. 2019 Nov 7;8(11):1909. doi: 10.3390/jcm8111909.

  PMID: 31703404 BACKGROUND

• Takasaki AA, Aoki A, Mizutani K, Schwarz F, Sculean A, Wang CY, Koshy G, Romanos G, Ishikawa I, Izumi Y. Application of antimicrobial photodynamic therapy in periodontal and peri-implant diseases. Periodontol 2000. 2009;51:109-40. doi: 10.1111/j.1600-0757.2009.00302.x. No abstract available.

  PMID: 19878472 BACKGROUND

• Ntrouka VI, Slot DE, Louropoulou A, Van der Weijden F. The effect of chemotherapeutic agents on contaminated titanium surfaces: a systematic review. Clin Oral Implants Res. 2011 Jul;22(7):681-690. doi: 10.1111/j.1600-0501.2010.02037.x. Epub 2010 Dec 29.

  PMID: 21198891 BACKGROUND

• Monje A, Pons R, Insua A, Nart J, Wang HL, Schwarz F. Morphology and severity of peri-implantitis bone defects. Clin Implant Dent Relat Res. 2019 Aug;21(4):635-643. doi: 10.1111/cid.12791. Epub 2019 May 14.

  PMID: 31087457 BACKGROUND

• Mombelli A, Decaillet F. The characteristics of biofilms in peri-implant disease. J Clin Periodontol. 2011 Mar;38 Suppl 11:203-13. doi: 10.1111/j.1600-051X.2010.01666.x.

  PMID: 21323716 BACKGROUND

• Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.

  PMID: 29926491 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Igor Smojver, DMD;PhD

CONTACT

385981651932; ismojver@sfzg.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sinior assistant

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)