Lasers in Peri-implantitis Treatment

NCT05733234 | Completed FDA Device

• 1 other identifier: Frag2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The current study aimed to investigate the effect of the combined Nd-Er: YAG laser on the surgical treatment of peri-implantitis by evaluating clinical markers and biomarkers of bone loss (RANKL/OPG). Twenty (20) patients having at least 1 implant diagnosed with peri-implantitis were randomly assigned to two groups for surgical treatment. In the test group (n=10), Er: YAG laser was used for granulation tissue removal and implant surface decontamination, while Nd: YAG laser was employed for deep tissue decontamination and biomodulation. In the control group (n=10), an access flap was applied, and mechanical instrumentation of the implant surface was performed by using titanium curettes. The following clinical parameters were evaluated at baseline and six months after treatment: Full-mouth Plaque Score (FMPS), Probing Pocket Depth (PPD), Probing Attachment Levels (PAL), recession (REC), and Bleeding on probing (BoP). Peri-implant crevicular fluid (PICF) was collected at baseline and six months for the evaluation of soluble RANKL and OPG utilizing enzyme-linked immunosorbent assay (ELISA).

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

• Probing Pocket Depth

  Clinical Periodontal Marker PPD: the distance from the mucosa margin to the bottom of the peri-implant pocket in mm, measured with a periodontal probe

  6 months

Secondary Outcomes (3)

• Probing Attachment Levels

  6 months

• Bleeding On Probing

  6 months

• Bone loss Biomarkers RANKL/OPG

  6 months

Study Arms (2)

Test

EXPERIMENTAL

Laser-assisted surgical treatment of peri-implantitis

Device: Laser ,Fotona, Light Walker AT, Ljubljana, Slovenia

Control

ACTIVE COMPARATOR

Surgical treatment of peri-implantitis - No laser

Drug: Mechanical Treatment

Interventions

Laser ,Fotona, Light Walker AT, Ljubljana, Slovenia DEVICE

Laser is used adjunctively in the surgical treatment of peri-implantitis for decontamination of the implant surface

Test

Mechanical Treatment DRUG

Dental instrument is used in combination with Chlorhexidine to decontaminate the implant surface

Control

Eligibility Criteria

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

You may qualify if:

• Probing depths of ≥6 mm,
• Bone levels ≥3 mm apical of the most coronal portion of the intraosseous part of the implant, and
• the simultaneous presence of bleeding on probing and/or suppuration
• Implants should be loaded for \>12 months.

You may not qualify if:

• A severe systematic disease of patients by which a surgical procedure cannot be performed (e.g., bleeding disorders, uncontrolled diabetes mellitus, etc.),
• treatment of peri-implantitis within the previous 12 months,
• antibiotic intake in the last three months before treatment and
• prosthetic loading of implants \> 12 months.
• In addition, peri-implantitis lesions indicated for regeneration (3-walled, craters were excluded from the study and were treated accordingly).

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Aristotle University of Thessaloniki

Thessaloniki, Makedonia, 54124, Greece

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 17, 2023
• Study Start: May 20, 2021
• Primary Completion: March 21, 2022
• Study Completion: March 21, 2022
• Last Updated: February 17, 2023

Record last verified: 2023-02

Locations

GR (1)