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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03782714
Enrollment
36
Registered
2018-12-20
Start date
2017-02-01
Completion date
2018-02-01
Last updated
2018-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulpotomy

Keywords

Low-level laser therapy, pulpotomy, formocresol

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.

Interventions

DEVICELow-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

Sponsors

King Abdulaziz University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

It is a split-mouth randomized controlled clinical trial

Eligibility

Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical success rate3 monthsThe pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility
Radiographic success rate3 monthsThe pulpotomy procedure was considered clinically successful if it demonstrated the following criteria: 1. Normal periodontal ligament space 2. No inter-radicular or periapical radiolucency 3. No internal or external root resorption

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026