Low-level Laser Therapy Versus Formocresol in Primary Molar Pulpotomies

NCT ID: NCT03782714

Last Updated: 2018-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2018-02-01

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 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.

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.

Conditions

Pulpotomy

Keywords

Low-level laser therapy, pulpotomy, formocresol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low-level laser therapy group

This group of teeth received laser irradiation after amputation of coronal pulp

Group Type: EXPERIMENTAL

Low-level laser therapy

Intervention Type: DEVICE

It is a diode laser device that has laser set at low level, used for pain relief and inflammation reduction to induce healing

Formocresol group

This group of teeth received the gold standard medication (formocresol) after coronal pulp amputation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Najlaa Alamoudi

Professor at the Pediatric Dentistry Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

King Abdulaziz University, Dental University Hospital

Jeddah, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

Alaa Nadhreen

Identifier Type: -

Identifier Source: org_study_id