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Use of Various Laser Systems in Peri-implatit

Primary Purpose

Peri-Implantitis

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Lasers

About this trial

This is an interventional treatment trial for Peri-Implantitis

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Presence of pocket in probing depth of ≥4 mm in at least one implant
No mobility in implant
Implants with bridge foot and opposite occlusion
Having no systemic disease that may affect the outcome of treatment
No systemic use of antibiotics for the last six months
Not receiving peri-implantitis treatment for the last three months
Individuals at the 30-60 years of age.

Exclusion Criteria:

Individuals who did not agree to participate in the study
Individuals receiving radiation therapy
Individuals using alcohol
Presence of pregnancy and lactation period
Individuals with parafunctional habits such as clenching or bruxism.

Sites / Locations

Kırıkkale University faculty of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Diode laser

Er,Cr:YSGG laser

Er:YAG LAser

Arm Description

Outcomes

Primary Outcome Measures

Sulcus depth

Secondary Outcome Measures

Full Information

NCT ID

NCT04826783

First Posted

January 23, 2021

Last Updated

March 31, 2021

Sponsor

Kırıkkale University

1. Study Identification

Unique Protocol Identification Number

NCT04826783

Brief Title

Use of Various Laser Systems in Peri-implatit

Official Title

Effect of Various Laser Systems in Smokers and Nonsmokers With Peri-implantitis: A Randomized, Prospective, Single-Blind Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 25, 2021 (Anticipated)

Primary Completion Date

October 25, 2021 (Anticipated)

Study Completion Date

April 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kırıkkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Objectives: In recent years, a new field of work has been created with the use of laser beam to provide titanium surface decontamination. The aim of this study was to evaluate the effect of various laser systems in smokers and non-smokers with peri-implantitis. Materials and Methods: According to the study protocol, patients, who were diagnosed with peri-implantitis based on the clinical and radiographic evaluations, were divided into six groups: Group 1: smokers undergoing diode laser application; Group 2: smokers undergoing Erbium, chromium: yttrium, scandium, gallium, garnet (Er, Cr:YSGG) laser application; Group 3: smokers undergoing Erbium:yttrium-aluminum-garnet (Er:YAG) laser application; Group 4: non-smokers undergoing diode laser application; Group 5: non-smokers undergoing Er, Cr:YSGG laser application; and Group 6: non-smokers undergoing Er:YAG laser application. Peri-implant sulcus depth (SD), clinical attachment level (CAL), suppuration, modified plaque index (mPI), gingival index (GI), and modified sulcus bleeding index (mSBI) were recorded and peri-implant sulcus fluid (PISF) was collected to evaluate osteocalcin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peri-Implantitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diode laser

Arm Type

Experimental

Arm Title

Er,Cr:YSGG laser

Arm Type

Experimental

Arm Title

Er:YAG LAser

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Lasers

Intervention Description

The laser tip was applied as vertical and horizontal scan along the subgingival implant . The procedure was carried out on day zero, seven and 14.

Primary Outcome Measure Information:

Title

Sulcus depth

Time Frame

basaline - six month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Presence of pocket in probing depth of ≥4 mm in at least one implant No mobility in implant Implants with bridge foot and opposite occlusion Having no systemic disease that may affect the outcome of treatment No systemic use of antibiotics for the last six months Not receiving peri-implantitis treatment for the last three months Individuals at the 30-60 years of age. Exclusion Criteria: Individuals who did not agree to participate in the study Individuals receiving radiation therapy Individuals using alcohol Presence of pregnancy and lactation period Individuals with parafunctional habits such as clenching or bruxism.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

kubilay barış

Phone

05539736477

dt.bkubilay@gmail.com

Facility Information:

Facility Name

Kırıkkale University faculty of Dentistry

City

Yahşihan

State/Province

Kırıkkale

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

kubilay barış

Phone

05539736477

dt.bkubilay@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Use of Various Laser Systems in Peri-implatit

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