A- The purpose of this study is to evaluate the clinical parameters after Er:YAG laser application in comparison with ultrasonic scaling and root planing. Study Design: The present study has a non- randomized, single-blind design. Therefore, the investigator who measures the clinical parameters is not aware of the type of treatment. Inclusion criteria: moderate chronic periodontitis disease; age over 18 years; not having systemic disease; no periodontal treatment in the last six months. Exclusion criteria: other treatments for periodontal disease during the study period. Study population: patients with chronic moderate periodontitis disease. Sample size twenty patients.
B- Study interventions: scaling with 1- Laser Er:YAG 2- ultrasonic method.
C- Intervention Time: 22/05/2014 to 23/08/2014
D- Consequences: Changes in periodontal clinical parameters including: plaque index; probing depth; bleeding on probing; clinical attachment loss and visual analogue scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402164877N18
Registration date:2014-06-17, 1393/03/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-17, 1393/03/27
Registrant information
Name
Jaber Yaghini
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 1434 2136
Email address
j_yaghini@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical Trial of the Comparison Between Clinical Parameters of Patients with Moderate Chronic Periodontitis Using Ultrasonic and Er:YAG
Public title
Evaluation of Clinical Periodontal Parameters After Scaling and Root planning with Er:YAG Laser Compared to Ultrasonic Instruments for treatment of Moderate Chronic Periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: moderate chronic periodontitis disease; age over 18 years; lack of systemic disease that can affect the outcome of treatment; no pregnancy; no previous periodontal treatment and systemic antibiotics therapy in the last 6 months; not being smoker; the presence of at least two teeth with probing depths greater than 4 mm in two quadrants.
Exclusion criteria: the patient’s unwillingness to continue the treatment; failure to properly follow the researchers’ instructions; being under other treatment and taking medications which may affect the result.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Dentistry, Isfahan University of Medical Sciences
Street address
School of Dentistry, Isfahan University of Medical Sciences, Hezarjerib st., Isfahan,Iran.
City
Isfahan
Postal code
8174673461
Approval date
2013-05-20, 1392/02/30
Ethics committee reference number
392408
Health conditions studied
1
Description of health condition studied
Moderate chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Plaque index
Timepoint
Before the intervention, after six weeks and twelve weeks after the end of intervention,
Method of measurement
Observation of index score
2
Description
Pocket depth
Timepoint
Before the intervention, after six weeks and twelve weeks after the end of intervention,
Method of measurement
Probing in millimeter
3
Description
Attachment loss
Timepoint
Before the intervention, after six weeks and twelve weeks after the end of intervention,
Method of measurement
Probing in millimeter
4
Description
Bleeding of Probing (BOP)
Timepoint
Before the intervention, after six weeks and twelve weeks after the end of intervention,
Method of measurement
Probing- No-unit
5
Description
Visual analogue scale
Timepoint
Immediately after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Er:YAG laser (Fotona-fidelis plus Ljubljana-Slovenia) with following characteristic: Wave length: 2490nm; Energy level: 160 mJ/pulse; Fiber tip: chisel shape; Hand piece: Ro14.
Category
Treatment - Other
2
Description
Ultrasound scaler (UDS-K 2012, Guilin woodpeker Medical instrument co) with following characteristic: output half-excursion force: more than 2N; output tip vibration frequency: 28kHz±3kHz; water pressure: 0.1bar to 5bar.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontal Department, School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Street address
Periodontal Department, School of Dentistry, Isfahan University of Medical Sciences, Hezarjerib st., Isfahan,Iran.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice of Research, School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Street address
Periodontal Department, School of Dentistry, Isfahan University of Medical Sciences, Hezarjerib st., Isfahan, Iran.
City
Isfahan
Grant name
Grant code / Reference number
392408
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice of Research, School of Dentistry, 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
Periodontal Department, School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Position
Assistant Professor
Other areas of specialty/work
Street address
Periodontal Department, School of Dentistry, Isfahan University of Medical Sciences, Hezarjerib st., Isfahan,Iran.
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2825
Fax
Email
j_yaghini@dnt.mui.ac.ir.
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Periodontal Department, School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Position
Assistant Professor
Other areas of specialty/work
Street address
Periodontal Department, School of Dentistry, Isfahan University of Medical Sciences, Hezarjerib st., Isfahan,Iran.
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2825
Fax
Email
j_yaghini@dnt.mui.ac.ir.
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Periodontal Department, School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Position
Assistant
Other areas of specialty/work
Street address
Periodontal Department, School of Dentistry, Isfahan University of Medical Sciences, Hezarjerib st., Isfahan,
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2825
Fax
Email
j_yaghini@dnt.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)