Protocol summary
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Study aim
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This trial aimed at assessment of clinical effectiveness of LANAP (laser assisted new attachment procedure) as an adjacent treatment to phase one in reducing periodontal pocket depths in patients diagnosed with chronic periodontitis
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Design
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The split-mouth double-masked placebo-controlled randomized clinical trial on 20 patients
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Settings and conduct
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This study is conducted in dental school of and Laser Research Center of Tehran University of Medical Sciences. This study is double bind as patients and the examiner are unaware of control and test sites.
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Participants/Inclusion and exclusion criteria
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Patients diagnosed with chronic periodontitis with at least 2 site with 4 mm or more probing depth are included; while those with systemic conditions affecting healing procedure,over contoured restorations, smokers, pregnant and lactating women and those who have taken antibiotics within the last month were excluded.
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Intervention groups
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Phase one will be accomplished for all the patients by a blinded practitioner. Oral Hygiene Indices (OHI) including Full Mouth Plaque Score (FMPS) , Full Mouth Bleeding Score (FMBS) , Periodontal Pocket Depth (PPD) , Clinical Attachment Loss (CAL) , Recession are recorded in 6 sites as baseline information. After random allocation, control group will undergo merely root debridement , however test group will receive LANAP as an adjacent treatment. Patients will be recalled every month until 6 months. OHI will be measured in every follow-up visit.
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Main outcome variables
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decrease In probing depth
General information
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Reason for update
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Due to end of clinical trial and update the information
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170827035937N2
Registration date:
2018-02-01, 1396/11/12
Registration timing:
retrospective
Last update:
2020-06-15, 1399/03/26
Update count:
1
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Registration date
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2018-02-01, 1396/11/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2017-12-30, 1396/10/09
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Expected recruitment end date
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2018-02-01, 1396/11/12
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Actual recruitment start date
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2017-12-22, 1396/10/01
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Actual recruitment end date
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2018-01-21, 1396/11/01
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Trial completion date
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2019-03-30, 1398/01/10
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Scientific title
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Clinical evaluation of the effect of LANAP ( Laser Assisted New Attachment Procedure) using Nd-YAG laser as an adjacent treatment in management of patients with chronic periodontits
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Public title
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Evaluation of laser therapy in chronic periodontitis treatment
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Amongst patients referred to periodontics department of dental school of Tehran University of Medical Sciences those who are diagnosed with chronic periodontitis with 4 mm and more probing depth and willing to participate
Exclusion criteria:
those with systemic conditions affecting healing procedure, smokers, pregnant women and those who are breast feeding and those who have taken antibiotics within the last month and sites with over contoured restorations are ruled in.
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
30
Actual sample size reached:
20
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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simple randomization , random numbers table
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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patient, main investigator and analyser
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Secondary Ids
1
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Registry name
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Clinical trials.gov
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Secondary trial Id
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NCT03365167
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Registration date
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2017-12-05, 1396/09/14
Ethics committees
1
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Ethics committee
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Approval date
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2018-01-24, 1396/11/04
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Ethics committee reference number
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IR.TUMS.DENTISTRY.REC.1396.4321
Health conditions studied
1
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Description of health condition studied
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Chronic periodontitis
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ICD-10 code
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K05.32
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ICD-10 code description
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Chronic periodontitis, generalized
Primary outcomes
1
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Description
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Periodontal pocket depth
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Timepoint
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Measurement is done before intervention and 1 , 3 and 6 months after LANAP
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Method of measurement
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O Michigan Periodontal Probe with Williams markings
Secondary outcomes
1
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Description
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Clinical Attachment Level
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Timepoint
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Before intervention and 1 , 3 and 6 months after LANAP
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Method of measurement
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O Michigan Periodontal Probe with Williams Markings
Intervention groups
1
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Description
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Intervention group: Scaling and Root planning+LANAP
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Category
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Treatment - Other
2
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Description
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Control group: Scaling and Root planning without LANAP
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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dentistry research institute, tehran university of medical sciences.
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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periodontal index
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When the data will become available and for how long
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starting 3 months after publication
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To whom data/document is available
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people working in academic institutions or people working in businesses
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Under which criteria data/document could be used
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related research or business interest field
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From where data/document is obtainable
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Email to responsible person of the study
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What processes are involved for a request to access data/document
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Email to responsible person of the study with details of their request and their CV
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Comments
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