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Endo-perio Lesion's Treatment With Using Diode Laser 940nm

Primary Purpose

Periodontitis, Endodontic Inflammation

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Endo-perio therapy with laser 940nm
Endo-perio therapy without laser 940nm
Sponsored by
Pomeranian Medical University Szczecin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring EPL, periodontitis, laser, CBCT

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • advanced periodontitis stage III, with endo-periodontal lesion without root damage,
  • presence of at least 20 teeth,
  • at least one molar tooth in each quadrant with a minimum of four teeth.

Exclusion Criteria:

-systemic illnesses (unbalanced diabetes mellitus, immunosuppressive drug or HIV), -

  • pregnancy or lactation,
  • smoking or alcoholism.

Sites / Locations

  • Pomeranian Medical UniversityRecruiting
  • Pomeranian Medical UniversityRecruiting
  • Pomeranian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

SRP and endontic treatment without laser 940nm

SRP and endodontic treatment with laser 940nm

Arm Description

Periodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals without using laser 940nm.

Periodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals with using laser 940nm.

Outcomes

Primary Outcome Measures

PD
periodontal pocket depht
Mobility Tooth
checking mobility with using Periotest
CBCT and STL
Cone Bean Computed Tomography, stereolithographic models

Secondary Outcome Measures

Full Information

First Posted
November 9, 2020
Last Updated
November 9, 2020
Sponsor
Pomeranian Medical University Szczecin
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1. Study Identification

Unique Protocol Identification Number
NCT04628845
Brief Title
Endo-perio Lesion's Treatment With Using Diode Laser 940nm
Official Title
Evaluation of Endo-perio Lesion's Treatment Using Additional Diode Laser 940nm.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pomeranian Medical University Szczecin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Periodontal marginal and periapical diseases cause a huge destruction of tissues surrounding the tooth with periodontal patients. Treatment consists on elimination of pathogens, which are presented in periodontal pockets and also in root canals. To increase efficiency of endo-perio treatment there is used diode laser wavelength 940nm. Laser disinfection is done in periodontal pockets and root canals. The aim of the study is to evaluate the effectiveness of treatment of endo-perio lesions with use of medicaments and diode laser. The study will present cases of endo-perio lesions around molars in investigated and control group. Teeth were subjected to endodontic and periodontological treatment. The roots and pockets have been disinfected with a diode laser only in investigated group. In the both groups between the visits into root canals there were applied alkaline paste. The treatment was completed after 6 months. Before the beginning and after the end of treatment there were made a two-dimensional image and CBCT. CBCT was subjected to manual segmentation. The resulting streolitographic models were allowed to check the change of bone volume.
Detailed Description
This study will presented the cases of two groups of patients, in which the endo-perio lesions were reported. The study protocol was approved by the Institutional Ethics Commission of Pomeranian University (No: KB-0012/29/17). Each subject provided informed consent after explanation of the protocol, risk and benefits of study.The both groups counted the same amount of molar teeth - ten molars in investigated (n=10) and in control group (n=10). In the study there were 9 men and 11 women aged between 35 and 58 years. The study was performed according to split-teeth design, computerized randomly allocated to the control or the investigated group. At first group (investigated group) there were implemented periodontal and endodontic treatment with additional using diode laser wavelength 940 nm. The same steps were made in control group, however without using diode laser in medical procedures. The first step was to do the clinical measurements (PD,CAL, tooth mobility, vitality test, occlusal condition) and analysis of pantomographic picture, the patients were diagnosed with third grade periodontitis The depth of periodontal pockets (PD) were checked by using manual periodontal probe (UNC 15, Hu-Friedy) on six sites. The classified teeth, which were diagnosed perio-endo lesions, were showed any vitality during testing faradic and ethyl chloride. The teeth did not respond properly. Also the tested teeth were checked with using Periotest M (Medizintechnik Gulden) in both groups before and after the treatment. Every enrolled patients were checked by using the T-scan Novus (Tekscan). T-scan system records patients bite force, dynamics, including occlusal force, location and timing. The treatment in EPL should be carried out in two ways- periodontal and endodontic. One of these ways there is mechanical non-surgical treatment of periodontium and endodontic way is eliminated the bacteria, which inside in root canals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Endodontic Inflammation
Keywords
EPL, periodontitis, laser, CBCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SRP and endontic treatment without laser 940nm
Arm Type
Placebo Comparator
Arm Description
Periodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals without using laser 940nm.
Arm Title
SRP and endodontic treatment with laser 940nm
Arm Type
Active Comparator
Arm Description
Periodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals with using laser 940nm.
Intervention Type
Device
Intervention Name(s)
Endo-perio therapy with laser 940nm
Intervention Description
Periodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals with using laser 940nm.
Intervention Type
Device
Intervention Name(s)
Endo-perio therapy without laser 940nm
Intervention Description
Periodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals
Primary Outcome Measure Information:
Title
PD
Description
periodontal pocket depht
Time Frame
up to 3 months
Title
Mobility Tooth
Description
checking mobility with using Periotest
Time Frame
up to 6 months
Title
CBCT and STL
Description
Cone Bean Computed Tomography, stereolithographic models
Time Frame
up to 6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: advanced periodontitis stage III, with endo-periodontal lesion without root damage, presence of at least 20 teeth, at least one molar tooth in each quadrant with a minimum of four teeth. Exclusion Criteria: -systemic illnesses (unbalanced diabetes mellitus, immunosuppressive drug or HIV), - pregnancy or lactation, smoking or alcoholism.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elżbieta Dembowska, Prof
Phone
48914661745
Email
elzbieta.dembowska@pum.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksandra Homik-Rodzińska, Msc
Phone
48697354804
Email
aleksandra.homik@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandra Homik-Rodzińska, Msc
Organizational Affiliation
lek.dent. Aleksandra Homik-Rodzińska
Official's Role
Study Director
Facility Information:
Facility Name
Pomeranian Medical University
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Pomeranian Medical University
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-200
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elżbieta Dembowska, Prof
Email
e.dembowska@vp.pl
Facility Name
Pomeranian Medical University
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-200
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elżbieta Dembowska, Prof
Email
e.dembowska@pum.edu.pl

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Documentation of study participants in paper form will be kept at the Department of Periodontology. We provide information on aggregate results in tables and statistical analysis after contact by email.

Learn more about this trial

Endo-perio Lesion's Treatment With Using Diode Laser 940nm

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