Clinical Evaluation of the Effect of LANAP as an Adjunct Treatment in Management of Patients With Chronic Periodontitis
Primary Purpose
Periodontitis, Laser
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
LANAP (Laser Assisted New Attachment Procedure)
LANAP off
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis focused on measuring LANAP, Periodontitis
Eligibility Criteria
Inclusion Criteria:
- definite diagnosis of chronic periodontitis with at least two teeth with periodontal pocket depth more than 4 mm in each side
Exclusion Criteria:
- pregnant smoker systemic disease breast feeding
Sites / Locations
- Neda Moslemi
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
LANAP
LANAP off
Arm Description
LANAP (Laser Assisted New Attachment Procedure)
laser therapy in off mode
Outcomes
Primary Outcome Measures
change of periodontal pocket depth
depth of periodontal pocket of each tooth
Secondary Outcome Measures
change of Bleeding on Probing
sign of bleeding after 1 minutes post probing the tooth pocket
change of Full Mouth Bleeding Score
Bleeding Score of all teeth that is calculated by counting the Four dental levels that have sign of bleeding post probing (including , mesio-buccal,mid- buccal, disto-buccal and lingual) divided by the total number of total teeth in the mouth *4
change of Clinical attachment loss
distance from depth of tooth sulcus to cemento-enamel junction
change of Full Mouth Plaque Score
the number of 4 surfaces of each tooth(mesiobuccal, mid buccal, disto buccal and lingual surfaces) that have plaque that is disclosed by disclosing tables , then counting the number of the colored surface of all teeth divided by the total number of total teeth in the mouth*4
Full Information
NCT ID
NCT03365167
First Posted
October 25, 2017
Last Updated
February 28, 2021
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03365167
Brief Title
Clinical Evaluation of the Effect of LANAP as an Adjunct Treatment in Management of Patients With Chronic Periodontitis
Official Title
Clinical Evaluation of the Effect of LANAP (Laser Assisted New Attachment Procedure) as an Adjunct Treatment in Management of Patients With Chronic Periodontitis( Randomized Clinical Trial Study)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 30, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
this study evaluate the effect of LANAP (Laser Assisted New Attachment Procedure) as an Adjunct Treatment in Management of Patients With Chronic Periodontitis and assay the effect of LANAP on periodontal indexes like BOP, CAL, probing depth
Detailed Description
this study evaluate the effect of LANAP (Laser Assisted New Attachment Procedure) as an Adjunct Treatment in Management of Patients With Chronic Periodontitis and assay the effect of LANAP on periodontal indexes like BOP, CAL, probing depth in a split mouth design before treatment and after follow up sessions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Laser
Keywords
LANAP, Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LANAP
Arm Type
Active Comparator
Arm Description
LANAP (Laser Assisted New Attachment Procedure)
Arm Title
LANAP off
Arm Type
Placebo Comparator
Arm Description
laser therapy in off mode
Intervention Type
Radiation
Intervention Name(s)
LANAP (Laser Assisted New Attachment Procedure)
Intervention Description
radiation of Nd:YAG laser in periodontal pocket
Intervention Type
Radiation
Intervention Name(s)
LANAP off
Intervention Description
radiation of Nd:YAG laser in off mode in periodontal pocket
Primary Outcome Measure Information:
Title
change of periodontal pocket depth
Description
depth of periodontal pocket of each tooth
Time Frame
0,1,2,3,4,5,6 months
Secondary Outcome Measure Information:
Title
change of Bleeding on Probing
Description
sign of bleeding after 1 minutes post probing the tooth pocket
Time Frame
0,1,2,3,4,5,6 month
Title
change of Full Mouth Bleeding Score
Description
Bleeding Score of all teeth that is calculated by counting the Four dental levels that have sign of bleeding post probing (including , mesio-buccal,mid- buccal, disto-buccal and lingual) divided by the total number of total teeth in the mouth *4
Time Frame
0,1,2,3,4,5,6 month
Title
change of Clinical attachment loss
Description
distance from depth of tooth sulcus to cemento-enamel junction
Time Frame
0,1,2,3,4,5,6 month
Title
change of Full Mouth Plaque Score
Description
the number of 4 surfaces of each tooth(mesiobuccal, mid buccal, disto buccal and lingual surfaces) that have plaque that is disclosed by disclosing tables , then counting the number of the colored surface of all teeth divided by the total number of total teeth in the mouth*4
Time Frame
0,1,2,3,4,5,6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
definite diagnosis of chronic periodontitis with at least two teeth with periodontal pocket depth more than 4 mm in each side
Exclusion Criteria:
pregnant smoker systemic disease breast feeding
Facility Information:
Facility Name
Neda Moslemi
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34411291
Citation
Dortaj D, Bassir SH, Hakimiha N, Hong H, Aslroosta H, Fekrazad R, Moslemi N. Efficacy of Nd:YAG laser-assisted periodontal therapy for the management of periodontitis: A double-blind split-mouth randomized controlled clinical trial. J Periodontol. 2022 May;93(5):662-672. doi: 10.1002/JPER.21-0242. Epub 2021 Sep 12.
Results Reference
derived
Learn more about this trial
Clinical Evaluation of the Effect of LANAP as an Adjunct Treatment in Management of Patients With Chronic Periodontitis
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