goal: comparison of clinical and microbial periodontal indexes changes using of low level Diode laser with and without Emundo photosensitizer material
study design: clinical trail
inclusion criteria: 4-6 mm pocket depth and 0.5-2 mm marginal bone loss around dental implant
exclusion criteria:patient poor oral hygiene and poor cooperation
sample size: 40 implants with primary peri implantitis in 20 patients
Periodontal treatment comprising scaling and root planning (SRP) was accomplished for the all mouth and mechanical debridement with fiber carbon curette and air polishing with bicarbonate sodium powder was accomplished around implants. Implants were randomly divided into two groups and treated with LT (control) and PDT (test).the clinical indices were measured at baseline, 6 weeks and 3 months after treatment. Microbiological samples were taken and evaluated at baseline and 3-month follow up. Data were entered in SPSS ver. 20 and analyzed with Friedman, repeated measure of ANOVA and Mann-Whitney tests (α=0.05).
time:2014-2015
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030932749N2
Registration date:2017-04-23, 1396/02/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-23, 1396/02/03
Registrant information
Name
mahboobeh rajabzadeh
Name of organization / entity
isfahan dental school
Country
Iran (Islamic Republic of)
Phone
+98 915 501 3649
Email address
m.rajabzadeh@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Isfahan University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effectiveness of Photodynamic Therapy with Low-level Diode Laser in Nonsurgical Treatment of Peri-implantitis
Public title
Evaluation of Effectiveness of Photodynamic Therapy with Low-level Diode Laser in Nonsurgical Treatment of Peri-implantitis
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria:
1. 4-6 mm pocket depth & 0.5-2 mm marginal bone loss
2. 2mm or more attached gingiva around implant
3. no systemic disease
4.no tobacco use
5.no use of antibiotics and drugs within previous 1month
6.no periodontal treatment except scaling and root planning within previous 2years
The exclusion criteria:
1.use of alcohol or tobacco 2.pregnancy or breastfeeding 3. use of antimicrobial agents during the previous 2 months 4. history of periodontal surgery during the previous year. 5. poor oral hygiene and no cooperation 6. need to gingival graft,with out attached gingiva
Age
From 20 years old to 67 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
isfahan medical sciences ethics committee
Street address
hezar jarib st/ isfahan
City
isfahan
Postal code
Approval date
2014-05-31, 1393/03/10
Ethics committee reference number
394383
Health conditions studied
1
Description of health condition studied
peri-implantitis or inflamatory condition around dental implant
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
probing depth measurement
Timepoint
before intervention/ 3month after intervention
Method of measurement
with periodontal probe/ milimeter
2
Description
papilla bleeding index
Timepoint
before intervention/ 3month after intervention
Method of measurement
index definition/ score to bleeding on probing
3
Description
modified plaque index
Timepoint
before intervention/ 3month after intervention
Method of measurement
index definition/ plaque accumulation rate
4
Description
microbial specimen
Timepoint
before intervention/ 3month after intervention
Method of measurement
microbial culture of crevicular gingival fluid / PCR
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: Periodontal treatment comprising scaling and root planning (SRP) was accomplished for the all mouth and mechanical debridement with fiber carbon curette and air polishing with bicarbonate sodium powder was accomplished around implants. (first treatment phase)
oral hygiene instruction (modified bass method) and flossing. (educational intervention)
two weeks later Photo Dynamic Therapy applied. (810 nm Diode laser+ Emundo Photosensitizer)
and this protocole repeated in two weeks after.
*EmonDo: indocyanine green /A.R.C. laser Gmbh, Germany
*Diode laser:Fox/ A.R.C. laser Gmbh, Germany
Category
Treatment - Other
2
Description
control group:
Periodontal treatment comprising scaling and root planning (SRP) was accomplished for the all mouth and mechanical debridement with fiber carbon curette and air polishing with bicarbonate sodium powder was accomplished around implants. (first treatment phase)
oral hygiene instruction (modified bass method) and flossing. (educational intervention)
two weeks later peri implantitis treated with 810 nm Diode laser.
and this protocole repeated in two weeks after.
*Diode laser:Fox/ A.R.C. laser Gmbh, Germany