Clinical Evaluation of the Effect of LANAP as an Adjunct Treatment in Management of Patients With Chronic Periodontitis

February 28, 2021 updated by: Neda Moslemi, Tehran University of Medical Sciences

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LANAP
LANAP (Laser Assisted New Attachment Procedure)
Radiation: LANAP (Laser Assisted New Attachment Procedure)
radiation of Nd:YAG laser in periodontal pocket
Placebo Comparator: LANAP off
laser therapy in off mode
Radiation: LANAP off
radiation of Nd:YAG laser in off mode in periodontal pocket

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of periodontal pocket depth
Time Frame: 0,1,2,3,4,5,6 months
depth of periodontal pocket of each tooth
0,1,2,3,4,5,6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of Bleeding on Probing
Time Frame: 0,1,2,3,4,5,6 month
sign of bleeding after 1 minutes post probing the tooth pocket
0,1,2,3,4,5,6 month
change of Full Mouth Bleeding Score
Time Frame: 0,1,2,3,4,5,6 month
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
0,1,2,3,4,5,6 month
change of Clinical attachment loss
Time Frame: 0,1,2,3,4,5,6 month
distance from depth of tooth sulcus to cemento-enamel junction
0,1,2,3,4,5,6 month
change of Full Mouth Plaque Score
Time Frame: 0,1,2,3,4,5,6 month
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
0,1,2,3,4,5,6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2017

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 30, 2019

Study Registration Dates

First Submitted

October 25, 2017

First Submitted That Met QC Criteria

December 6, 2017

First Posted (Actual)

December 7, 2017

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

February 28, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 96-02-97-36092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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