Comparision of the clinical and microbiological effects of photodynamic therapy as an adjunctive treatment with scaling and root planning with scaling and root planning alone in aggressive periodontitis
The aim of the present study was to compare the effects of photodynamic therapy as an adjunctive treatment with scaling and root planning with the scaling and root planning alone on clinical and microbiological parameters in patients with aggressive periodontitis. Inclusion and exclusion criteria: patients with aggressive periodontitis and no systemic disease were selected. Study population, sample size and primary outcome: Twenty eight patients with aggressive periodontitis as split mouth design and based on inclusion criteria were selected. In order to evaluate periodontal status, the clinical parameters of clinical attachment level as primary outcome, probing depth, gingival Index, Plaque Index and bleeding on probing were measured and recorded before treatment and at 3 month after treatment. Microbial parameters of the study, the quantitave level of Aa, were determined by special laboratory kits of real-time PCR at the same time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211277128N3
Registration date:2012-12-23, 1391/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-23, 1391/10/03
Registrant information
Name
Adileh Shirmohammadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
shirmohamadia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Science
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of the clinical and microbiological effects of photodynamic therapy as an adjunctive treatment with scaling and root planning with scaling and root planning alone in aggressive periodontitis
Public title
Comparision of the effect of photodynamic therapy associated with scaling and scaling alone in aggrissive gingival disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: A total of 28 patients; with an age range of 18-45 years, suffering from aggressive periodontitis; The subjects had at least 12 teeth and at least 3 teeth in each quadrant and one tooth with CAL≥4mm in each quadrant. Exclusion criteria: systemic disease; conditions which delay would healing; a history of radiotherapy or immune-suppressive treatment modalities; pregnancy or breast-feeling; use of systemic antibiotics during the 6 previous months; history of scaling and root planning during the previous year.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Science
Street address
Dentistry Faculty, Daneshgah St, Golgasht
City
Tabriz
Postal code
5566614711
Approval date
2012-10-20, 1391/07/29
Ethics committee reference number
91128
Health conditions studied
1
Description of health condition studied
aggresive periodontitis
ICD-10 code
K05.4 Peri
ICD-10 code description
Juvenile periodontosis
Primary outcomes
1
Description
Clinical attachment level (CAL)
Timepoint
baseline and 3 month later
Method of measurement
milimeter distance from CEJ to bottom of pocket with a periodontal probe
Secondary outcomes
1
Description
Probing Depth (PD)
Timepoint
baseline and 3 month later
Method of measurement
milimeter distance from gingival margin to botom of pocket
2
Description
bleeding on probing (BOP)
Timepoint
baseline and 3 month later
Method of measurement
presence or absence of bleeding 30 s after probing
3
Description
recession (REC)
Timepoint
baseline and 3 month later
Method of measurement
milimeter distance from CEJ to gingival margin
4
Description
Plaque Index (PI)
Timepoint
baseline and 3 month later
Method of measurement
Oleary Plaque Index
5
Description
Gingival Index(GI)
Timepoint
baseline and 3 month later
Method of measurement
Loe & Silness introduced it base on imflamation and ademe and redness and important object of it, is bleeding
6
Description
quantitive measurment of Aa (Aggregatibacter actinomycetemcomitans)
Timepoint
baseline and 3 month later
Method of measurement
real time PCR by special laboratory kits of real-time PCR
Intervention groups
1
Description
control: scaling and rootplanning as full mouth approach in all quadrants
Category
Treatment - Other
2
Description
intervention: Scaling and root planning with photodynamic teraphy in the selected teeth with PD≥4mm after application of photosensitizer and then the irradition of the laser with wavelength 670-690 nm with energy of 75 mW/cm2 for 120 seconds
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Dentistry faculty, Periodontics ward, Tabriz University of Medical Science
Full name of responsible person
Dr Adile Shirmohamadi
Street address
Daneshgah st, Golgasht
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Dr Reza Pourabbas
Street address
Daneshgah st, Golgasht
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?