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

Periodontitis Clinical Trial

Official title:

Evaluation of Endo-perio Lesion's Treatment Using Additional Diode Laser 940nm.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04628845
• Other study ID #: Interventional
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: November 2020
• Source: Pomeranian Medical University Szczecin
• Contact: Elzbieta Dembowska, Prof
• Phone: 48914661745
• Email: elzbieta.dembowska[@]pum.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Endodontic Inflammation
• Inflammation
• Periodontitis
• Pulpitis

Intervention

Device:
• Endo-perio therapy with laser 940nm
Periodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals with using laser 940nm.
• Endo-perio therapy without laser 940nm
Periodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals

Locations

Country	Name	City	State
Poland	Pomeranian Medical University	Szczecin	Zachodniopomorskie
Poland	Pomeranian Medical University	Szczecin	Zachodniopomorskie
Poland	Pomeranian Medical University	Szczecin	Zachodniopomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PD	periodontal pocket depht	up to 3 months
Primary	Mobility Tooth	checking mobility with using Periotest	up to 6 months
Primary	CBCT and STL	Cone Bean Computed Tomography, stereolithographic models	up to 6 months