Status:

COMPLETED

Low-level Laser Therapy Versus Formocresol in Primary Molar Pulpotomies

Lead Sponsor:

King Abdulaziz University

Conditions:

Pulpotomy

Eligibility:

All Genders

5-8 years

Phase:

NA

Brief Summary

This study aimed to assess and compare the clinical and radiographic success rates of LLLT and FC for pulpotomy in human primary teeth. One hundred and six primary molars from 36 children aging five t...

Detailed Description

Background: Various agents are available to dress the remaining pulp tissue after pulpotomy procedure with the formocresol (FC) being the gold standard for the last 60 years. Nowadays, low-level laser...

Eligibility Criteria

Inclusion

  • Children inclusion criteria:
  • Children aged 5-8 years with at least two bilateral deep carious primary molars indicated for pulpotomy.
  • Children who are physically and mentally healthy without any known medical history of systemic conditions contraindicating pulp therapy.
  • Children who had "positive" or "definitely positive" behavioral ratings according to the Frankl behavior classification scale (Frankl, 1962).
  • Children whose parents signed an informed consent for the child's participation in the study.
  • Teeth inclusion criteria:
  • Teeth were selected according to clinical and radiographic criteria.
  • Clinically, the study included:
  • Teeth with restorable crowns
  • Teeth with pathologic carious exposure of vital pulps
  • Teeth with no tenderness to percussion, physiologic or pathologic mobility or any clinical evidence of pulp inflammation or degeneration such as history of swelling, pain or presence of sinus tract.
  • Radiographically, the recruited teeth should have:
  • Normal radiographic appearance with healthy supporting tissues
  • No pulp calcification
  • No internal or external root resorption
  • No periapical or inter-radicular radiolucency
  • At least two thirds of the root remaining (not more than one third of the root is physiologically resorbed)

Exclusion

  • Any child complained of clinical signs such as pain, swelling, abnormal mobility, vertical or lateral tenderness to percussion was excluded from the study.
  • Radiographically, any child with signs of internal or external root resorption or periapical or inter-radicular pathology was omitted from the study.

Key Trial Info

Start Date :

February 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2018

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT03782714

Start Date

February 1 2017

End Date

February 1 2018

Last Update

December 20 2018

Active Locations (1)

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1

King Abdulaziz University, Dental University Hospital

Jeddah, Saudi Arabia, 21589