NCT04826783

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

April 25, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2022

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

January 23, 2021

Last Update Submit

March 31, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sulcus depth

    basaline - six month

Study Arms (3)

Diode laser

EXPERIMENTAL
Device: Lasers

Er,Cr:YSGG laser

EXPERIMENTAL
Device: Lasers

Er:YAG LAser

EXPERIMENTAL
Device: Lasers

Interventions

LasersDEVICE

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.

Diode laserEr,Cr:YSGG laserEr:YAG LAser

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale University faculty of Dentistry

Yahşihan, Kırıkkale, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Lasers

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Central Study Contacts

kubilay barış

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr.

Study Record Dates

First Submitted

January 23, 2021

First Posted

April 1, 2021

Study Start

April 25, 2021

Primary Completion

October 25, 2021

Study Completion

April 25, 2022

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations