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Efficacy of Diode Laser in Peri-implantitis

Primary Purpose

Implant, Peri-Implantitis, Alveolar Bone Loss

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional peri-implantitis treatment
DL application in peri-implantitis
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Implant focused on measuring dental implant, laser, diode laser, peri-implantitis, bacterial count

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years and older
  • No local and systemic health problems prohibit the study interventions
  • Bi-lateral implants with peri-implantitis diagnosis

Exclusion Criteria:

  • Local and systemic health problems prohibiting the study interventions

Sites / Locations

  • Department of Oral Implantology, Faculty of Dentistry, Istanbul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional peri-implantitis treatment

DL application in peri-implantitis

Arm Description

Peri-implantitis treatment according to the Cumulative interceptive supportive (CIST) therapy.

Adjunct Diode Laser application.

Outcomes

Primary Outcome Measures

Bacterial counts
Bacterial load around the the diseased implants will be determined at the initiation of the study. The assessment will be performed after one months

Secondary Outcome Measures

Marginal Bone loss
The marginal bone loss around the diseased implants will be assessed after six months to analyse any bone level change.

Full Information

First Posted
September 16, 2014
Last Updated
February 12, 2015
Sponsor
Istanbul University
Collaborators
Istanbul University Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT02362854
Brief Title
Efficacy of Diode Laser in Peri-implantitis
Official Title
A Randomized Clinical Trial of an Adjunct Diode Laser Application in the Treatment of Peri-implantitis.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
Collaborators
Istanbul University Research Fund

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study was to compare the efficacy of a diode laser (DL) as an adjunct to conventional scaling in the treatment of mild-to-moderate peri-implantitis. A prospective clinical, radiographic and microbiologic split-mouth study was conducted to test the following null hypothesis; adjunct application of a diode laser, in the conventional treatment of peri-implantitis, are not associated with a statistically significant difference regarding the microbial counts, marginal bone loss and peri-implant parameters.
Detailed Description
Efficacy of a diode laser (DL) in peri-implantitis was investigated. 48 implants diagnosed with peri-implantitis were included. In addition to the conventional scaling and debridement, random 24 implants were lased by a DL. Periodontal indexes, microbiologic specimens and radiographs were used for assessment. Baseline parameters were similar between groups. After six months laser group revealed higher MBL than the control group. Microbiota of the implants were found unchanged after one month. DL appears to have no additional positive influence on the peri-implantitis treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Implant, Peri-Implantitis, Alveolar Bone Loss, Complications
Keywords
dental implant, laser, diode laser, peri-implantitis, bacterial count

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional peri-implantitis treatment
Arm Type
Active Comparator
Arm Description
Peri-implantitis treatment according to the Cumulative interceptive supportive (CIST) therapy.
Arm Title
DL application in peri-implantitis
Arm Type
Experimental
Arm Description
Adjunct Diode Laser application.
Intervention Type
Procedure
Intervention Name(s)
Conventional peri-implantitis treatment
Other Intervention Name(s)
CIST treatment protocol
Intervention Description
Elimination of the bacterial plaque. Establishing optimal healing conditions. Detoxification of the affected environment.
Intervention Type
Device
Intervention Name(s)
DL application in peri-implantitis
Intervention Description
Diode laser application in the diseased implants.
Primary Outcome Measure Information:
Title
Bacterial counts
Description
Bacterial load around the the diseased implants will be determined at the initiation of the study. The assessment will be performed after one months
Time Frame
One month
Secondary Outcome Measure Information:
Title
Marginal Bone loss
Description
The marginal bone loss around the diseased implants will be assessed after six months to analyse any bone level change.
Time Frame
Six months
Other Pre-specified Outcome Measures:
Title
Peri-implant health indexes
Description
Bleeding on probing, probing depth and plaque index which determined at the initiation of the study will be re-evaluated after one and six months to asees the effect of the variables
Time Frame
one and six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years and older No local and systemic health problems prohibit the study interventions Bi-lateral implants with peri-implantitis diagnosis Exclusion Criteria: Local and systemic health problems prohibiting the study interventions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volkan Arısan, Ass.Prof.Dr.
Organizational Affiliation
Istanbul University, Faculty of Dentistry
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cuneyt Karabuda, Prof.Dr.
Organizational Affiliation
Istanbul University, Faculty of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Department of Oral Implantology, Faculty of Dentistry, Istanbul University
City
Istanbul
State/Province
Capa
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Links:
URL
http://dishekimligi.istanbul.edu.tr/oral-implantoji/
Description
Department web link

Learn more about this trial

Efficacy of Diode Laser in Peri-implantitis

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