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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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History
# Registration date Revision Id
2 2020-06-08, 1399/03/19 139006
1 2018-02-01, 1396/11/12 35444
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  • Protocol summary

    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
    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
    بررسی تاثیر بالینی LANAP (تشکیل اتصالات جدید با کمک لیزر)به عنوان در مان مکمل فاز یک در کاهش پاکت های پریودنتال در افراد دارای پریودنتیت مزمن
    هدف این مطالعه بررسی تاثیر بالینی LANAP (تشکیل اتصالات جدید با کمک لیزر) به عنوان درمان مکمل فاز یک در کاهش پاکت های پریودنتال در افراد دارای پریودنتیت مزمن می باشد
    40 patients diagnosed with chronic periodontitis acquiring bilateral pockets 4 mm or deeper are selected. In every patient one quadrant of jaw is randomly assigned as control and the other one as test.
    The split-mouth double-masked placebo-controlled randomized clinical trial on 20 patients
    در اين مطالعه ٤٠ بيمار مبتلا به پريودنتيت مزمن داراي پاكت هاي ٤ ميلي متر يا بيشتر به صورت دو طرفه و داراي شرايط ورود به مطالعه كه به بخش پريودانتيكس دانشكده دندانپزشكي دانشگاه علوم پزشكي تهران مراجعه كرده اند انتخاب ميشوند. در هر بيمار يك سمت دهان به صورت تصادفي در گروه كنترل و سمت مقابل در گروه مداخله قرار ميگيرد.
    کارآزمایی بالینی دارای گروه کنترل، با طراحیspilt mouth ، دو سویه کور ، تصادفی شده، بر روی ۲۰ بیمار
    محل انجام مطالعه در دانشكده دندانپزشكي دانشگاه علوم پزشكي تهران و پژوهشكده ليزر دانشگاه علوم پزشكي تهران مي باشد. اين مطالعه به صورت دو سو كور و بدين صورت كه بيمار و كلينيسين معاينه گر از گروه هاي مداخله و كنترل ناآگاه هستند انجام ميگيرد.
    محل انجام مطالعه در دانشكده دندانپزشكي و پژوهشكده ليزر دانشگاه علوم پزشكي تهران مي باشد. اين مطالعه به صورت دو سو كور و بدين صورت كه بيمار و كلينيسين معاينه گر از گروه هاي مداخله و كنترل ناآگاه هستند انجام ميگيرد.
    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 excluding 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
    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.
    بیمار از بین مراجعه کنندگان به بخش پریودنتولوژی دانشکده دندانپزشکی دانشگاه علوم پزشکی تهران با تشخیص پریودنتیت مزمن وارد مطالعه میشوند. بیمارانی که دارای شرایط سیستمیک مداخله کننده با درمان هستند، بیمارانی که سیگار میکشند، باردار هستند یا در دوران شیردهی قرار دارند، در یک ماه اخیر آنتی بیوتیک مصرف کرده اند و بیمارانی که ترمیم یا رستوریشن ناقص در محل پروبینگ دارند و از مطالعه حذف میشوند. بیمارانی که وارد مطالعه میشوند باید حداقل دو سایت در هر دو طرف با عمق پاکت 4 میلیمتر یا بیشتر داشته باشند
    بیماران با تشخیص پریودنتیت مزمن که حداقل دو سایت در هر دو طرف فک با عمق پاکت 4 میلیمتر یا بیشتر داشته باشند وارد مطالعه میشوند. بیماران با شرایط سیستمیک مداخله کننده با درمان ،با ترمیم یا رستوریشن ناقص در محل پروبینگ، بیماران سیگاری، باردار یا در دوران شیردهی و نیز بیمارنی که در یک ماه اخیر آنتی بیوتیک مصرف کرده اند مطالعه حذف میشوند.
    In case of successful results, LANAP can be used as an adjacent treatment to conventional methods, specially when localized pockets are left plus it can help to prevent unnecessary antibiotic prescription.
    decrease In probing depth
    در صورت دستیابی به نتایج موفقیت آمیز، میتوان از LANAP به عنوان درمان مکمل پس از درمان فاز ɪ بهره برد، به ویژه در مواردی که پاکت های باقی مانده به صورت موضعی باشند و همین طور استفاده از این روش در جلوگیری از مصرف بیش از حد آنتی بیوتیک ها میتواند مفید باشد.
    کاهش عمق پاکت پریودنتال

  • General information

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    2017-12-22, 1396/10/01
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    2018-01-21, 1396/11/01
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    2019-03-30, 1398/01/10
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    Due to end of clinical trial and update the information
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    به این علت که انجام مطالعه پایان یافته و نتایج بروز شود
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    40
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  • Intervention groups

    #1
    Intervention group: Scaling and Root planning
    Intervention group: Scaling and Root planning+LANAP
    گروه مداخله: جرمگیری و دبریدمان ریشه
    گروه مداخله: جرمگیری و دبریدمان ریشه+ درمان LANAP
    #2
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    Placebo
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    Control group: Scaling and Root planning without LANAP
    empty
    گروه کنترل: جرمگیری و دبریدمان ریشه بدون درمان LANAP

Protocol summary

Study aim
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
Design
The split-mouth double-masked placebo-controlled randomized clinical trial on 20 patients
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
decrease In probing depth

General information

Reason for update
Due to end of clinical trial and update the information
Acronym
IRCT registration information
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
Registration date
2018-02-01, 1396/11/12
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 4824
Email address
n-hakimiha@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-30, 1396/10/09
Expected recruitment end date
2018-02-01, 1396/11/12
Actual recruitment start date
2017-12-22, 1396/10/01
Actual recruitment end date
2018-01-21, 1396/11/01
Trial completion date
2019-03-30, 1398/01/10
Scientific title
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
Public title
Evaluation of laser therapy in chronic periodontitis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 30
Actual sample size reached: 20
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization , random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
patient, main investigator and analyser
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
Clinical trials.gov
Secondary trial Id
NCT03365167
Registration date
2017-12-05, 1396/09/14

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
4th floor,No:23, 16 Azar street,Keshavarz Blv.
City
Tehran
Province
Tehran
Postal code
1417863181
Approval date
2018-01-24, 1396/11/04
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1396.4321

Health conditions studied

1

Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.32
ICD-10 code description
Chronic periodontitis, generalized

Primary outcomes

1

Description
Periodontal pocket depth
Timepoint
Measurement is done before intervention and 1 , 3 and 6 months after LANAP
Method of measurement
O Michigan Periodontal Probe with Williams markings

Secondary outcomes

1

Description
Clinical Attachment Level
Timepoint
Before intervention and 1 , 3 and 6 months after LANAP
Method of measurement
O Michigan Periodontal Probe with Williams Markings

Intervention groups

1

Description
Intervention group: Scaling and Root planning+LANAP
Category
Treatment - Other

2

Description
Control group: Scaling and Root planning without LANAP
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental School of Tehran University of Medical Sciences
Full name of responsible person
Neda Moslemi
Street address
Dental School of Tehran University of Medical Sciences , North Kargar St. Tehran
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
neda_moslemi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
dentistry research institute, tehran university of medical sciences.
Full name of responsible person
Neda Moslemi
Street address
Dental School of Theran University of Medical Sciences , North Kargar St.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
neda_moslemi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
dentistry research institute, tehran university of medical sciences.
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
neda moslemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
NOrth kargar street, dental faculty of medical sciences
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4342
Email
neda_moslemi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
neda moslemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
North kargar, dental faculty of medical sciences
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4342
Email
neda_moslemi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
neda moslemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
north kargar st. dental faculty of tehran medical university
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4342
Email
neda_moslemi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
periodontal index
When the data will become available and for how long
starting 3 months after publication
To whom data/document is available
people working in academic institutions or people working in businesses
Under which criteria data/document could be used
related research or business interest field
From where data/document is obtainable
Email to responsible person of the study
What processes are involved for a request to access data/document
Email to responsible person of the study with details of their request and their CV
Comments
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