Efficiency of Soft Tissue Diode Laser Application on Healing of Periapical Tissues

NCT ID: NCT04311879

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2020-01-01

Brief Summary

Study is a Randomized clinical trial conducted at Endodontic department- Ain Shams university Cairo. Egypt. 24 eligible patients were selected and included in the study to compare healing ability of soft tissue diode laser application versus conventional root canal treatment using CBCT

Detailed Description

Sample size is 24 24 Patients were randomly distributed in 2 groups , one group of patients received soft tissue laser therapy after root canal treatment and the other group received no treatment just conventional RCT. • Patients were equally divided into 2 groups (n=12 in each group ) The study in a Single blinded RCT , Numbers for patients will be generated and distributed randomly in a table on an Excel sheet, and in front of each number either a letter (C) for control or (I) for intervention will be typed After patients were selected in the study they will be asked to fill in a consent form , that states that they are part of a clinical trial and that they may or may not have a laser session following root canal treatment Group A Soft tissue laser application : Endodontically treated teeth were targeted by virtue of a dental applicator positioned at a right angle to the mucosa at the level of the apices. Application of the laser probe were applied to both the buccal and lingual mucosae overlying the apices of the target tooth. Total exposure time for each tooth was 60 seconds (a dose = 70 j/cm2 for analgesia) by the co-investigator The laser unit used in this study will be a diode laser (Lite Medics 1.00 Watt serial number 148 Ver.SwvM. 150VS108VT.100) of wavelength 980nm and Max power 15 WCW Class IV Laser Product ) in continuous wave mode Group B : Placebo : conventional root canal treatment : mock laser intervention A CBCT was taken preoperative and after 12 month postoperative, both linear and volumetric measurements were calculated

Conditions

Periapical Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Soft tissue laser Diode laser application

Endodontically treated teeth by virtue of a dental applicator positioned at a right angle to the mucosa at the level of the apices. Application of the laser probe was applied to both the buccal and lingual mucosae overlying the apices of the target tooth. Total exposure time for each tooth was 60 seconds (a dose = 70 j/cm2 for analgesia) The laser unit used in this study used was a diode laser (Lite Medics 1.00Watt serial number 148 Ver.SwvM. 150VS108VT.100) of wavelength 980nm and Max power 15WCW Class IV Laser Product

Group Type: EXPERIMENTAL

Soft tissue Diode laser application

Intervention Type: DEVICE

post-operative soft tissue diode laser application

conventional root canal treatment

Placebo : conventional root canal conventional root canal treatment with irrigation of sodium hypochlorite 2.5% with mock laser intervention

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

mock diode laser application

Interventions

Soft tissue Diode laser application

post-operative soft tissue diode laser application

Intervention Type: DEVICE

Placebo

mock diode laser application

Intervention Type: OTHER

Other Intervention Names

Low laser therapy

Eligibility Criteria

Inclusion Criteria

• Adult patients age between 18-50 years
• Medically free patients.
• Patients suffering from acute or chronic infection with symptomatic apical periodontitis with Necrotic pulp
• Preoperative Pain
• Sensitivity to percussion
• Periapical radiographic X-ray showing periapical lesion with no gutta percha in canal
• Occlusal contact with opposing teeth

Exclusion Criteria

• Pregnant females.
• Patients having a significant systemic disorder or history of drug abuse
• Patients who had administrated analgesics or antibiotics during the last 12 hours preoperatively.
• Patients having bruxism or clenching
• Teeth having:

• No occlusal contact
• No sensitivity to percussion
• Greater than grade I mobility.
• Pocket depth greater than 5mm.
• No possible restorability
• Procedural errors
• Previous Root canal treatment
• Open apex

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Hend Hamdy Ismail

PhD candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maram Obeid, PhD

Role: STUDY_DIRECTOR

AinShams University

Ehab Hassanien, PhD

Role: STUDY_CHAIR

Ainshams University

Locations

Endodontic department - Faculty of Dentistry Ainshams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

END 16-14D

Identifier Type: -

Identifier Source: org_study_id