Efficacy of antimicrobial photodynamic therapy as an adjunctive to mechanical debridement in the treatment of peri-implant diseases: a randomized controlled clinical trial
Aim: the purpose of present study was to assess the clinical effects of anti-microbial photodynamic therapy after closed surface scaling in the treatment of peri-implant diseases.
Study design: randomized controlled clinical trial.
Methods and inclusion/exclusion criteria: 15 pairs of dental implants, in 10 patients, showed clinical and radiographical signs of peri-implant diseases and located at different quadrants included in this study. In each patient, one implant randomly served as control implant and the other served as test implant. The control implants were treated with closed surface scaling only and the test implants received additionally photodynamic therapy, using light with a wavelength of 630 nm and the intensity of 2000 mw/cm2 for 120 s after application of photisensitizer in peri-implant sulcus. Clinical parameters were evaluated before and 1.5 and 3 months after treatment. Data were analyzed statistically.
Interventions: closed surface scaling- photodynamic therapy.
Primary outcome: clinical attachment loss- probing pocket depth.
General information
Acronym
PDT= PhotoDynamicTherapy
IRCT registration information
IRCT registration number:IRCT201309119260N2
Registration date:2013-10-12, 1392/07/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-12, 1392/07/20
Registrant information
Name
Mohammad Reza Karimii
Name of organization / entity
Islamic Azad university Dental Branch
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 4746
Email address
m_karimi@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
The study was self-funded by the authors.
Expected recruitment start date
2011-03-16, 1389/12/25
Expected recruitment end date
2012-07-01, 1391/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of antimicrobial photodynamic therapy as an adjunctive to mechanical debridement in the treatment of peri-implant diseases: a randomized controlled clinical trial
Public title
PDT in treatment of peri-implant diseases
Purpose
Treatment
Inclusion/Exclusion criteria
• Presence of at least two screw type titanium dental implants, in different sites, exhibiting clinical and radiographic signs of peri-implant diseases (including peri-implant mucositis and peri-implantitis).
• No implant mobility
• No evidence of occlusal overload
• No treatment of peri-implant diseases for the least 6 months before the study
• No use of antibiotics and anti-inflammatory drugs for the 3 months prior treatment. If these drugs were taken during the study, patient would be excluded.
• At least 1 year function of implants.
• No pregnancy and nursing
• No uncontrolled diabetes (HbA1c < 7)
• In the cases that subjects had a history of periodontitis, only subjects were included if the lesions were treated at the remaining teeth and diseases was halted.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
this is single-blind split mouth clinical trial
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran Islamic Azad university, Dental branch
Street address
no 4, 10 th neyestan, pasdaran street
City
tehran
Postal code
19585-175
Approval date
2011-02-19, 1389/11/30
Ethics committee reference number
د/250/پ
Health conditions studied
1
Description of health condition studied
peri-implant diseases
ICD-10 code
K00-K14
ICD-10 code description
k05.6
Primary outcomes
1
Description
peri-implant probing pocket depth
Timepoint
before treatment, 1.5 and 3 months after treatment
Method of measurement
millimeter using williams plastic probe
2
Description
peri-implant clinical attachment loss(CAL)
Timepoint
before treatment, 1.5 and 3 months after treatment
Method of measurement
millimeter using williams plastic probe
Secondary outcomes
1
Description
peri-implant bleeding after probing(BOP)
Timepoint
before treatment, 1.5 and 3 months after treatment
Method of measurement
PBI index
2
Description
peri-implant gingival index(GI)
Timepoint
before treatment, 1.5 and 3 months after treatment
Method of measurement
gingival index
Intervention groups
1
Description
control: All implants underwent mechanical debridement, using plastic curettes followed by pocket irrigation with sterile saline. Hand instrumentation was carried out until the operator was assured that the implant surfaces were adequately debrided and no time restriction was considered. In control group, no further treatment was performed.
intervention: in the PDT group, closed surface scaling followed by single-episode of photodynamic therapy. High medium photosensitizerwas injected inside the instrumented peri-implant pocket with a thin blunt needle, as far as mucosal margin starting from the apical portion of the pocket. The photosensitizer was left in the pocket for 3 minutes. Subsequently, the light emitting device with the wavelength of 630 nm and the intensity of 2000 mw/cm2, with a special tip was placed at the depth of pocket, according to the manufacturer’s instruction. The device, used in this research for implant surface irradiation, was in contact with 6 aspects per implant. Every aspect of implants was irradiated for 20 seconds, making a total of 2 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Office of Dr. Mohammadreza Karimi
Full name of responsible person
Dr. Mohammadreza Karimi
Street address
floor 4, negin tower, afrigha street
City
Tehran
2
Recruitment center
Name of recruitment center
Office of Dr. Ali Hasani
Full name of responsible person
Dr. Ali Hasani
Street address
block 5, floor 4, negin tower, afrigha street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
this study was self-funded by researchers.
Full name of responsible person
Dr. Salva Khosroshahian
Street address
no 4, meghdad, sepah, safaie street
City
qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
this study was self-funded by researchers.
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
islamic azad university, dental branch
Full name of responsible person
Dr. mohammadreza karimi
Position
assistant professor of periodontics department, islamic azad university
Other areas of specialty/work
Street address
department of periodontology, no 4, 10th neyestan, pasdaran street
City
tehran
Postal code
Phone
+98 21 2276 3449
Fax
Email
m_karimi@dentaliau.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
islamic azad university, dental branch
Full name of responsible person
Dr. Mohammadreza Karimi
Position
assistant professor of department of periodontology, islamic azad university
Other areas of specialty/work
Street address
department of periodontology, no 4, 10th neyestan, pasdaran street
City
tehran
Postal code
Phone
+98 21 2276 3449
Fax
Email
m_karimi@dentaliau.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
islamic azad university, dental branch
Full name of responsible person
Dr. Mohammadreza Karimi
Position
assistant professor, department of periodontology of islamic azad university
Other areas of specialty/work
Street address
no 4, 10th neyestan, pasdaran street
City
tehran
Postal code
Phone
+98 21 2276 3449
Fax
Email
m_karimi@dentaliau.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)