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

NCT ID: NCT05137821

Last Updated: 2023-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-10

Study Completion Date

2023-11-15

Brief Summary

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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.

Detailed Description

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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.

The study was designed as an Ex Vivo study. Four periodontally and systemically healthy volunteers of both gender are included in this study for the formation of in vivo plaque biofilm. Each volunteer will wear a hard resin splint carrying six rough (machined implant; 3.3mm diameter, 8mm length) for 4 days to accumulate dental plaque naturally on the titanium surfaces of the implants.

Therefore, 24 implants will be assessed for Er: YSGG laser therapy in different bone defect simulators.

Conditions

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Peri-Implantitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two group control and test group test group divided into four subgroups
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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non tested comparative group

two sealed new implants as a control

Group Type EXPERIMENTAL

no therapy

Intervention Type OTHER

new sealed implant without any surface treatment

Er: YSGG laser tested group

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

Group Type EXPERIMENTAL

Er: YSGG laser

Intervention Type DEVICE

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

Interventions

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Er: YSGG laser

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

Intervention Type DEVICE

no therapy

new sealed implant without any surface treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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alaa

Assistant lecturer of oral medicine and periodontology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams Dental School

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 39174958 (View on PubMed)

Other Identifiers

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FDASU-REC ID210314

Identifier Type: -

Identifier Source: org_study_id

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