This study is a Double-Blind randomized clinical trial that is to be done by Full mouth design method. Totally 50 patient are to be checked with the below criteria: having periodontal pocket with 5 mm depth and more; having an ideal hygienic mouth stand; not having dental plaque and having 20% full mouth plaque score (FMPS). It also needs to be mentioned these patient have chronic periodontitis that have not answered to phase one treatment and periodontal pocket is left. It needs to be said that the patient`s age range is 35 and more the below criteria are seen for the patients who are to checked in this study. Remaining periodontal pocket after performing phase one; not having systematic disease; not being in pregnancy period; not smoking and using any drugs; being under a six month antibiotic`s treatment. The patient will be under SRP (Scaling and Root planning) treatment after a clinical check-up and registering the below parameters: 1. Bleeding on probing (BOP). 2. Clinical attachment loss (CAL). 3. Plaque index (PI). 4. Full mouth plaque score (FMPS). 5. Full mouth bleeding score (FMBS). 6. Periodontal probing depth (PPD). In order to see that there is no dental plaque. The patients are to be checked-up in the 1st 3rd and 7th days one week after SRP every single gets radiated in 3 sessions over 3 days that every radiation is in the 1st 3rd 7th days over a week in this research. We randomly split the patients into 2 groups called beholder and goal. The goal group: the patients continuously go under photodynamic therapy with 810 nanometer Diode laser Having 300 mw power in 10 seconds and 3 joule energy in 6 adjacent dental points followed by EmuDo photosensitizer . The beholder group: the patients go under SRP treatment with physiology serum and off laser. The approved patients are to be reviewed and compared in one three and six month intervals.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013110215236N1
Registration date:2014-02-05, 1392/11/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-05, 1392/11/16
Registrant information
Name
Abbas Monzavi
Name of organization / entity
Laser Research Center of Dentistry, Tehran Unversity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 5017
Email address
monzavia@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran Unversity of Medical Sciences / monzavia@sina.tums.ac.ir
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Treatment of periodontitis and chronic periodontitis and the complications
Public title
Treatment of gum disease
Purpose
Treatment
Inclusion/Exclusion criteria
This study is a double –blind randomized clinical trial and is done in a full mouth design. Totally 44 patients to be surveyed in this study . The patient have periodontal pocket with 5 mm depth and more it also needs to be mentioned that these patients have Chronic periodontitis that have not answered to phase one and the periodontal pocket is left in them. It must be said that the age rage is 35 and over it more over. These patients criteria is remaining periodontal pocket after doing phase one. More over to these facts:
1. The patients must be without systematic disease.
2. Pregnant patients are not to be taken part.
3. The patients must not use drugs or smoke.
4. The patients must not have used any antibiotic in a 6 month period.
The patients go under SRP treatment for the 2nd time after clinical check-up and registering parameters like BOP / CAL / PPD / FMBS / FMPS and PI. If one the 50 patients FMPS is lower than 20% he/she gets radiated in the 1st 2nd and 7th days during 3 sessions in 3 days. In order to se that there is no dental plaque the patients are to be checked-up one week after doing SRP. Every patients left pocket gets radiated with Diode laser and EmunDo. The sensitive substance to light (photosensitizer) The day after check-up in the 1st 3rd and 7th days over a week.
In goal group: all teeth go under PDT with Diode laser followed by EmunDo photosensitizer having 300 mw power in 10 seconds and 3 joule energy in 6 adjacent dental points.
In beholder group all teeth including those that have periodontal pocket with the depth of 5 mm and more and without periodontal pocket go under SRP with physiologic serum and off laser. than the patients are to be re-studied and compared in one three and six month intervals.
Age
From 35 years old to 60 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Office of Research Affairs (research assistant)
Street address
Tehran
City
Tehran
Postal code
Approval date
2012-11-11, 1391/08/21
Ethics committee reference number
91-04-97-20051-103312
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Gingivitis and periodontal diseases
Primary outcomes
1
Description
1. Bleeding on probing (BOP)
Timepoint
Scaling done before / after scaling a week / a month after laser irradiation / Three months after laser irradiation / Six months after laser irradiation
Method of measurement
Observed / measured probe
2
Description
Clinical attachment loss (CAL)
Timepoint
Scaling done before / after scaling a week / a month after laser irradiation / Three months after laser irradiation / Six months after laser irradiation
Method of measurement
Observed
3
Description
Plaque index (PI)
Timepoint
Scaling done before / after scaling a week / a month after laser irradiation / Three months after laser irradiation / Six months after laser irradiation
Method of measurement
Observed
4
Description
Full mouth plaque score (FMPS)
Timepoint
Scaling done before / after scaling a week / a month after laser irradiation / Three months after laser irradiation / Six months after laser irradiation
Method of measurement
Observed
5
Description
Full mouth bleeding score (FMBS)
Timepoint
Scaling done before / after scaling a week / a month after laser irradiation / Three months after laser irradiation / Six months after laser irradiation
Method of measurement
Observed
6
Description
Periodontal probing depth (PPD)
Timepoint
Scaling done before / after scaling a week / a month after laser irradiation / Three months after laser irradiation / Six months after laser irradiation
Method of measurement
Observed / measured probe
Secondary outcomes
empty
Intervention groups
1
Description
The patient will be under SRP (Scaling and Root planing) treatment after a clinical check-up and registering the below parameters:
1. Bleeding on probing (BOP)
2. Clinical attachment loss (CAL)
3. Plaque index (PI)
4. Full mouth plaque score (FMPS)
5. Full mouth bleeding score (FMBS)
6. Periodontal probing depth (PPD)
In order to see that there is no dental plaque. The patients are to be checked-up in the 1st 3rd and 7th days one week after SRP every single gets radiated in 3 sessions over 3 days that every radiation is in the 1st 3rd 7th days over a week in this research. We randomly split the patients into 2 groups called beholder and goal.
The goal group:
The patients continuously go under photodynamic therapy with 810 nanometer Diode laser Having 300 mw power in 10 seconds and 3 joule energy in 6 adjacent dental points followed by EmuDo photosensitizer .
Category
Placebo
2
Description
The beholder group:
The patients go under SRP treatment with physiology serum and off laser. the approved patients are to be reviewed and compared in one three and six month intervals.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontology, Dental School, Tehran University of Medical Sciences
Full name of responsible person
Omid Bagherpasand Tamijani
Street address
Dental School, Tehran University of Medical Sciences, North Amir Abad Tst. Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Laser Department, Dental School of Tehran University of Medical Sciences
Full name of responsible person
Abas Monzavi
Street address
Dental School, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Laser Department, Dental School of Tehran 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
Dental School, Tehran University of Medical Sciences
Full name of responsible person
Omid Bagherpasand Tamijani
Position
Doctor of Dental Medicine
Other areas of specialty/work
Street address
Dental School, Tehran University of Medical Sciences, North Amir Abad Tst. Tehran
City
Tehran
Postal code
Phone
Fax
Email
omid.dds67@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental School, Tehran University of Medical Sciences
Full name of responsible person
Abbas Monzavi
Position
Associate professor
Other areas of specialty/work
Street address
Dental School, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
Fax
Email
monzavia@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental School, Tehran University of Medical Sciences
Full name of responsible person
Omid Bagherpasand Tamijani
Position
Doctor of Dental Medicine
Other areas of specialty/work
Street address
Dental School, Tehran University of Medical Sciences, North Amir Abad Tst. Tehran
City
Tehran
Postal code
Phone
Fax
Email
omid.dds67@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)