NCT05964686

Brief Summary

The aim of this study is to assess in vivo the efficacy of Er,Cr:YSGG/diode laser and Diode/EDTA on bacterial count in root canal treatment in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in total bacterial count reduction between conventional irrigation and the two types of lasers used. Thirty patients are equally divided into 3 separate groups :

  • Group A (Conventional): 2.5% NaOCL and 17% EDTA.
  • Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
  • Group C(Combined): saline along with 17% EDTA and diode laser combination Microbiological analysis will be done for both aerobic and anaerobic bacteria using Colony forming units. All data will be collected, tabulated, summarized, and statistically analyzed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
Last Updated

November 29, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

July 4, 2023

Last Update Submit

November 24, 2023

Conditions

Pulp and Periapical Tissue DiseasePulp NecrosesPulp; Granuloma

Keywords

LASEREndodonticscanal disinfection

Outcome Measures

Primary Outcomes (1)

  • Quantitative microbiological analysis

    aerobic bacterial count will be assessed using colony forming units (CFU) and will be expressed in (CFU/ml). anaerobic bacterial count will be assessed using colony forming units (CFU) and will be expressed in (CFU/ml).

    baseline (S1): sample will be obtained before canal disinfection. post operative (S2): sample will be obtained after canal disinfection in a single visit]

Study Arms (3)

Conventional group A

ACTIVE COMPARATOR
Combination Product: Conventional group (NaOCl/EDTA)

Dual laser group B

EXPERIMENTAL
Combination Product: Dual laser group (Er,Cr:YSGG/Diode):

Combined group C

EXPERIMENTAL
Combination Product: Combined group (EDTA/Diode):

Interventions

Conventional group (NaOCl/EDTA)COMBINATION_PRODUCT

conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA

Conventional group A
Dual laser group (Er,Cr:YSGG/Diode):COMBINATION_PRODUCT

Er,Cr:YSGG intracanal laser irradiation to remove smear layer followed by diode laser for disinfection

Dual laser group B
Combined group (EDTA/Diode):COMBINATION_PRODUCT

17% EDTA was used to remove smear layer followed by diode laser for disinfection

Combined group C

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who are medically free.
  • Patient's age between 18-35 years.
  • One single rooted maxillary anterior tooth with necrotic pulp and asymptomatic apical periodontitis requiring root canal treatment.
  • Patients complaining of no pain and without fistulous tract.
  • Periapical lesion with a periapical index score of 3 or 4 (Ørstavik, et al. (1986)108
  • Closed apex.
  • Acceptance to participate in the study.

You may not qualify if:

  • Patients suffering from any systemic disease.
  • Patients who had received antibiotics during the last month.
  • Patients taking analgesics 12 hours before interventions.
  • Patients with history of tobacco usage
  • Teeth with vital pulp, calcified canals, and immature or incompletely formed apices.
  • Teeth with previous endodontic treatment.
  • Non restorable teeth where rubber dam could not be applied.
  • Teeth with periodontal pocket more than 3 mm.
  • Teeth with greater than grade 1 mobility.
  • Teeth with swelling/sinus tract.
  • Technical difficulties in the course of root canal treatment for example:
  • A tooth with curved roots

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Abbassia, 11566, Egypt

Location

MeSH Terms

Conditions

Dental Pulp NecrosisGranuloma

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

July 4, 2023

First Posted

July 28, 2023

Study Start

January 1, 2022

Primary Completion

September 30, 2022

Study Completion

December 30, 2022

Last Updated

November 29, 2023

Record last verified: 2023-07

Locations

EG(1)