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

NCT04311879 | Completed

• 1 other identifier: END 16-14D
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Periapical Diseases

Keywords

Diode laser; low level laser therapy; CBCT

Outcome Measures

Primary Outcomes (1)

• Assess post-operative healing in a period of 12 month when using Soft tissue diode laser application post-operative using CBCT

  12 months

Study Arms (2)

Soft tissue laser Diode laser application

EXPERIMENTAL

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

Device: Soft tissue Diode laser application

conventional root canal treatment

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Soft tissue Diode laser application DEVICE

post-operative soft tissue diode laser application

Also known as: Low laser therapy

Soft tissue laser Diode laser application

Placebo OTHER

mock diode laser application

conventional root canal treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Endodontic department - Faculty of Dentistry Ainshams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Periapical Diseases

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Maram Obeid, PhD

  AinShams University

  STUDY DIRECTOR

• Ehab Hassanien, PhD

  Ainshams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: March 7, 2020
• First Posted: March 17, 2020
• Study Start: July 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: January 1, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)