Low-level Laser Therapy Versus Formocresol in Primary Molar Pulpotomies

Clinical and Radiographic Evaluation of Low-level Laser Therapy in Human Primary Molar Pulpotomies: A Randomized Controlled Clinical Trial

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 to eight years were included and randomly assigned into two equal groups; LLLT group and FC group. Teeth were evaluated clinically and radiographically at 3, 6 and 12 months.

Study Overview

• Status: Completed
• Conditions: Pulpotomy
• Intervention / Treatment: Device: Low-level laser therapy

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 therapy (LLLT) becomes a technique of interest, due to its many characteristics. However, the literature available on its success in pulpotomy is limited and reported conflicting results.

Aim of the study: To assess and compare the clinical and radiographic success rates of LLLT and FC for pulpotomy in human primary teeth.

Materials and methods: Utilizing split-mouth technique, the sample consisted of 106 primary molars from 36 children aging five to eight years. The teeth were selected based on specific clinical and radiographic inclusion criteria and randomly assigned into two equal groups; LLLT group and FC group. All the 106 primary molars were indicated for pulpotomy, where 53 teeth were treated using FC and 53 teeth were treated with LLLT. Teeth were evaluated clinically and radiographically at 3, 6 and 12 months.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia, 21589
    • King Abdulaziz University, Dental University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-level laser therapy group; This group of teeth received laser irradiation after amputation of coronal pulp	Device: Low-level laser therapy; It is a diode laser device that has laser set at low level, used for pain relief and inflammation reduction to induce healing
No Intervention: Formocresol group; This group of teeth received the gold standard medication (formocresol) after coronal pulp amputation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success rate	The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility	3 months
Clinical success rate	The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility	6 months
Clinical success rate	The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility	12 months
Radiographic success rate	The pulpotomy procedure was considered clinically successful if it demonstrated the following criteria: Normal periodontal ligament space; No inter-radicular or periapical radiolucency; No internal or external root resorption	3 months
Radiographic success rate	The pulpotomy procedure was considered clinically successful if it demonstrated the following criteria: Normal periodontal ligament space; No inter-radicular or periapical radiolucency; No internal or external root resorption	6 months
Radiographic success rate	The pulpotomy procedure was considered clinically successful if it demonstrated the following criteria: Normal periodontal ligament space; No inter-radicular or periapical radiolucency; No internal or external root resorption	12 months

Collaborators and Investigators

• Sponsor: King Abdulaziz University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: December 16, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Low-level laser therapy, pulpotomy, formocresol
• Other Study ID Numbers: Alaa Nadhreen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No