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

NCT ID: NCT04628845

Last Updated: 2020-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-31

Study Completion Date

2022-08-31

Brief Summary

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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

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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.

Conditions

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Periodontitis Endodontic Inflammation

Keywords

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EPL periodontitis laser CBCT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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SRP and endontic treatment without laser 940nm

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

Group Type PLACEBO_COMPARATOR

Endo-perio therapy without laser 940nm

Intervention Type DEVICE

Periodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals

SRP and endodontic treatment with laser 940nm

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

Group Type ACTIVE_COMPARATOR

Endo-perio therapy with laser 940nm

Intervention Type DEVICE

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

Interventions

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Endo-perio therapy with laser 940nm

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

Intervention Type DEVICE

Endo-perio therapy without laser 940nm

Periodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pomeranian Medical University Szczecin

OTHER

Sponsor Role lead

Responsible Party

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Elżbieta Dembowska

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aleksandra Homik-Rodzińska, Msc

Role: STUDY_DIRECTOR

lek.dent. Aleksandra Homik-Rodzińska

Locations

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Pomeranian Medical University

Szczecin, West Pomeranian Voivodeship, Poland

Site Status RECRUITING

Pomeranian Medical University

Szczecin, West Pomeranian Voivodeship, Poland

Site Status RECRUITING

Pomeranian Medical University

Szczecin, West Pomeranian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Elżbieta Dembowska, Prof

Role: CONTACT

Phone: 48914661745

Email: [email protected]

Aleksandra Homik-Rodzińska, Msc

Role: CONTACT

Phone: 48697354804

Email: [email protected]

Facility Contacts

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Elżbieta Dembowska, Prof

Role: primary

Elżbieta Dembowska, Prof

Role: primary

Other Identifiers

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Interventional

Identifier Type: -

Identifier Source: org_study_id