Protocol summary

Summary
Objectives: The purpose of present study is to evaluate the impact of non-surgical laser therapy and photodynamic therapy on chronic periodontitis. Design: In this randomized clinical trial, twenty patients with chronic periodontitis were selected among the patients referring to Isfahan University of medical sciences by convenience sampling. Setting and Conduct: Mechanical debridement was accomplished for the whole mouth. Applying a split-mouth design, each quadrant was randomly treated with one of the therapeutic interventions. This randomization was done with table of randomization numbers. Participants: the patients should be systemically healthy and no smoker. Interventions: therapeutic interventions including 1- mechanical debridement alone, 2- mechanical debridement +laser therapy, or 3- mechanical debridement + photodynamic therapy were accomplished in 2 sessions within 2 weeks. Variables: The clinical indices including, pocket probing depth, clinical attachment level, papillary bleeding index and plaque index were measured at baseline, 6 weeks and 3 months after treatment. Microbiological samples were taken and evaluated at baseline and 3-month follow-up. Triple blinding during the study procedure was performed for patient (by placebo treatment in other quadrants), researcher and data monitoring committee (by unawareness of intervention process).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015021021029N1
Registration date: 2015-04-15, 1394/01/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-04-15, 1394/01/26
Registrant information
Name
Sima Kiani
Name of organization / entity
Department of Periodentology, dental school, Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2842
Email address
simakiani@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Faculty of Dentistry, Isfahan University of Medical Sciences.
Expected recruitment start date
2014-01-31, 1392/11/11
Expected recruitment end date
2014-02-28, 1392/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of non-surgical periodontal treatment with diode laser or photodynamic therapy with Emundo mixture on clinical and microbiological indices in patients with chronic periodontitis
Public title
The effect of laser therapy on chronic gingival disease
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: 1) Age ≥ 18, 2) Systemically healthy, 3) Remaining teeth ≥ 20, 4) Presence of three or more quadrants of mouth, each containing at least three sites with periodontal pocket depth (PPD) of 4-7 mm and clinical attachment level (CAL) of 2 mm or greater, 5) Signed inform consent form exclusion criteria: 1) Smoking or alcoholism, 2) Pregnancy or lactating, 3) Consuming antimicrobial drugs (i.e. antibiotics) in the last 2 months, and 4) History of periodontal surgery in the last year
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan university of medical sciences, Hezarjerib avenues, Isfahan
City
Isfahan
Postal code
81746 -73461
Approval date
2015-02-23, 1393/12/04
Ethics committee reference number
393386

Health conditions studied

1

Description of health condition studied
chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic inflammatory disease of supporting tooth structure

Primary outcomes

1

Description
pocket probing depth
Timepoint
Before Treatment, one month and 3 months after intervention
Method of measurement
probing with periodontal probe

Secondary outcomes

1

Description
clinical attachment level
Timepoint
Before Treatment , one month and 3 months after intervention
Method of measurement
probing with periodontal probe

Intervention groups

1

Description
intervention 3: control group: with laser device while it is off as placebo and photodynamic mixture while its syringe is blunt
Category
Placebo

2

Description
intervention1: laser therapy with Diode laser with a wavelength of 810 (@Fox, A.R.C. laser GmbH, Germany)
Category
Treatment - Other

3

Description
intervention 3: photodynamic therapy with Diode laser with a wave length of 810 and applying ® Emundo mixture (® Emundo, A.R.C. laser GmbH, Germany) as photosensitizer
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences, School of Dentistry
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Dental school of Isfahan University of Medical Sciences
Full name of responsible person
Dr. Omid Savabi
Street address
Research vice chancellor, Isfahan Dental School, Isfahan University of Medical Sciences, Hezarjerib Avenue, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Dental school of Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan Faculty of Dentistry
Full name of responsible person
Dr. Omid Savabi
Position
Proficiency of Prosthesis - Professor
Other areas of specialty/work
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezarjerib avenue, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2812
Fax
Email
research@dnt.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan Faculty of Dentistry
Full name of responsible person
Dr. Omid Savabi
Position
Proficiency in Prosthesis
Other areas of specialty/work
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezarjerib avenue, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2812
Fax
Email
research@dnt.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan Faculty of Dentistry
Full name of responsible person
Dr. Omid Savabi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 31 3792 2812
Fax
Email
research@dnt.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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