compare the clinical effects including bleeding on probing and pocket depth between nonsurgical mechanical debridement and photodynamic therapy in peri-implant disease.
Design
During a randomized controlled clinical trial, fifty patients entered the study, using the Randlist 1.2 software, were divided into two groups of 25, based on the randomization principles and feasibility studies, and based on the list of the hereditism of the above software. , Will be treated with mechanical debridement and photodynamic therapy.
Settings and conduct
Patients eligible for study in periodontics department of Tabriz Dental School entered the study
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Bleeding on probing
Depth of probing greater than or equal to 4 mm
sub functional implant for <1 year
Exclusion criteria:
smoking
Pregnancy and lactation
Addicted to drugs and alcohol
Uncontrolled diabetes and debilitating systemic diseases
Intervention groups
The initial treatment protocol in both groups includes health education and removal of the mass and plaque using the ultrasonic curing apparatus (250.EMSElectroMedical SA.Nyon.Switzeriand with metal cams) followed by using Aire -Powder Polishin Polishing of the teeth and implant was performed on the top of the gum and under the gum فاثد.semi patients treated with photodynamic therapy using Photosensitizer with a low-power diode laser (nm805, w5 / 0) using an inhaled cyanine green immediately after mechanical debridement.Photodynamic Therapy (PDT) is a new therapeutic method for the removal of infectious pathogens using photosensitizer and radiation with a specific length. PDT can be used locally in periodontal pocket .
Main outcome variables
Bleeding on probe؛
Depth of pocket؛
Pain during probe؛
Pus
General information
Reason for update
Acronym
PI
IRCT registration information
IRCT registration number:IRCT20180913041033N1
Registration date:2019-01-07, 1397/10/17
Registration timing:retrospective
Last update:2019-01-07, 1397/10/17
Update count:0
Registration date
2019-01-07, 1397/10/17
Registrant information
Name
davod fathollahzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3331 9677
Email address
davood.fathollahzade@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-25, 1396/02/05
Expected recruitment end date
2017-11-10, 1396/08/19
Actual recruitment start date
2017-04-29, 1396/02/09
Actual recruitment end date
2018-03-10, 1396/12/19
Trial completion date
2018-03-10, 1396/12/19
Scientific title
The effects of photo dynamic therapy and nonsurgical mechanical debriment on pocket depth and bleeding of probing in peri-implant disease
Public title
peri implant disease
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria
bleeding of probing(bop)
Depth of probing greater than or equal to four millimeters
Under the implant's function for 1 year or more
Failure of recession soft tissue with or without a minimum bone recession less than or equal to 2 mm
Exclusion criteria:
Exclusion criteria
Pregnancy and lactation
Addicted to drugs and alcohol
Uncontrolled diabetes and disabling systemic disease
smokers
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
49
Randomization (investigator's opinion)
Randomized
Randomization description
50 patients selected, half of them were randomly selected using the software and received photodynamic therapy.
Blinding (investigator's opinion)
Not 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 Sciences.
Two weeks after mechanical and photodynamic therapy and at the end of the follow-up phase
Method of measurement
Bleeding on probing:The probe is carefully inserted into the pocket and slowly moves to the side of the implant and records bleeding if observed.
Secondary outcomes
1
Description
suppuration
Timepoint
Baseline two weeks later, three months later
Method of measurement
The presence of (1) or loss of (0) by itself, after a probe or gingival pressure around the implant, Recorded with finger
2
Description
Pain on Probing(POP)
Timepoint
Baseline two weeks later, three months later
Method of measurement
How to measure pain using the Visual Analogue Scale (VAS) method: A ruler that is about ten centimeters in length is provided to the patient, and it is explained that if the pain is greatest in the entire length of the ruler and the lowest in the left end In this case, mark the amount of pain on the ruler. The distance from the marked point to the left is measured and reported in cm.
3
Description
Probing Depth (PD)
Timepoint
Baseline two weeks later, three months later
Method of measurement
Depth of probe: In six points around the implants (Mesobuccal, Mid Buccal, Disto Buccal, Meso Lingual, Disto Lingual and Mid Lingual), the margin of the mucosa of the implant was measured to the depth of the gingival area with the probe and the deepest probe region was recorded as the probing depth
Intervention groups
1
Description
control group:: The initial treatment protocol in both groups includes health education and removal of the mass and plaque using the ultrasonic curing apparatus (250.EMSElectroMedical SA.Nyon.Switzeriand with metal cams) followed by using Aire -Powder Polishin Polishing of the teeth and implant was performed on the top of the gum and under the gum.
Category
Treatment - Other
2
Description
Intervention group: The initial treatment protocol in both groups includes health education and removal of the mass and plaque using the ultrasonic curing apparatus (250.EMSElectroMedical SA.Nyon.Switzeriand with metal cams) followed by using Aire -Powder Polishin Polishing of the teeth and implant was performed on the top of the gum and under the gum فاثد.semi patients treated with photodynamic therapy using Photosensitizer with a low-power diode laser (nm805, w5 / 0) using an inhaled cyanine green immediately after mechanical debridement.Photodynamic Therapy (PDT) is a new therapeutic method for the removal of infectious pathogens using photosensitizer and radiation with a specific length. PDT can be used locally in periodontal envelopes and prevent overhead associated with administration of systemic anti-microbial drugs. Slowly It also reduces the appearance of bacterial resistance.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontology, Faculty of Dentistry, Tabriz