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

NCT04628845 | Unknown

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Periodontitis; Endodontic Inflammation

Keywords

EPL; periodontitis; laser; CBCT

Outcome Measures

Primary Outcomes (3)

• PD

  periodontal pocket depht

  up to 3 months

• Mobility Tooth

  checking mobility with using Periotest

  up to 6 months

• CBCT and STL

  Cone Bean Computed Tomography, stereolithographic models

  up to 6 months

Study Arms (2)

SRP and endontic treatment without laser 940nm

PLACEBO COMPARATOR

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

Device: Endo-perio therapy without laser 940nm

SRP and endodontic treatment with laser 940nm

ACTIVE COMPARATOR

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

Device: Endo-perio therapy with laser 940nm

Interventions

Endo-perio therapy with laser 940nm DEVICE

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

SRP and endodontic treatment with laser 940nm

Endo-perio therapy without laser 940nm DEVICE

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

SRP and endontic treatment without laser 940nm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• systemic illnesses (unbalanced diabetes mellitus, immunosuppressive drug or HIV), -
• pregnancy or lactation,
• smoking or alcoholism.

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (3)

Pomeranian Medical University

Szczecin, West Pomeranian Voivodeship, 70-200, Poland

RECRUITING

Pomeranian Medical University

Szczecin, West Pomeranian Voivodeship, 70-200, Poland

RECRUITING

Pomeranian Medical University

Szczecin, West Pomeranian Voivodeship, 70-200, Poland

RECRUITING

MeSH Terms

Conditions

Periodontitis; Pulpitis

Interventions

Lasers

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Pulp Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Aleksandra Homik-Rodzińska, Msc

  lek.dent. Aleksandra Homik-Rodzińska

  STUDY DIRECTOR

Central Study Contacts

Elżbieta Dembowska, Prof

CONTACT

48914661745; elzbieta.dembowska@pum.edu.pl

Aleksandra Homik-Rodzińska, Msc

CONTACT

48697354804; aleksandra.homik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 16, 2020
• Study Start: August 31, 2019
• Primary Completion: December 31, 2021
• Study Completion: August 31, 2022
• Last Updated: November 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3)