Efficacy of Er: YSGG Laser in Treatment of Peri-implantitis

NCT05137821 | Completed FDA Device

• 1 other identifier: FDASU-REC ID210314
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be carried out to evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in various peri-implant defect morphology in the treatment of peri-implantitis as a primary objective. To assess the morphological changes and the biological response (biocompatibility) of implant surface after Er: YSGG laser therapy through Profilometer analysis and cell culture process to detect attachment, differentiation, and mineralization of Isolated rat Bone Marrow Mesenchymal stem cells (rBMMSCs) respectively as secondary objectives.

Conditions

Peri-Implantitis

Keywords

Er: YSGG laser therapy; Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

• visual inspection of the oral biofilm removal efficacy by image analysis software (Adobe Photoshop

  evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in various peri-implant defect morphology

  2 weeks

Secondary Outcomes (1)

• Profilometer analysis of surface roughness changes

  1 month

Other Outcomes (1)

• biocompatibility test of the surface

  2 months

Study Arms (2)

non tested comparative group

EXPERIMENTAL

two sealed new implants as a control

Other: no therapy

Er: YSGG laser tested group

EXPERIMENTAL

24 infected implants divided into four subgroups that will be decontaminated by Er: YSGG laser in various peri-implant defects

Device: Er: YSGG laser

Interventions

Er: YSGG laser DEVICE

Er: YSGG laser decontamination of infected implant surfaces to simulate peri-implantitis therapy

Er: YSGG laser tested group

no therapy OTHER

new sealed implant without any surface treatment

non tested comparative group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sex: female or male.
• Age: 25 - 55 years.
• Medically controlled according to medical coding of review of systems (ROS)

You may not qualify if:

• Tobacco smoking for at least 6 months before the study enrollment
• Participants with ill-fitting restorations in both upper first molars that affect the stability of the stent.
• Participants not following oral hygiene instructions.
• Participants on dental treatment during the study period.
• Participants with a history of drug administration
• Vulnerable group.
• Participants with long-term mouthwash administration.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams Dental School

Cairo, 11411, Egypt

Location

Related Publications (1)

• Hashim A, Kheir El Din NH, El-Khazragy N, Almalahy HG. Comparison of the efficacy of Er,Cr:YSGG laser on oral biofilm removal from implant surfaces with various application times for the treatment of peri-implantitis defects: ex vivo study. BMC Oral Health. 2024 Aug 22;24(1):980. doi: 10.1186/s12903-024-04698-5.

  PMID: 39174958 DERIVED

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: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of oral medicine and periodontology

Model Details: two group control and test group test group divided into four subgroups

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: November 30, 2021
• Study Start: August 10, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 15, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

EG (1)