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NCT Number: NCT03782714

Low-level Laser Therapy Versus Formocresol in Primary Molar Pulpotomies

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.

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Key information

Conditions

Pulpotomy

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdulaziz University, Dental University Hospital

Jeddah, 21589, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-Level Laser Therapy

Device

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

Primary outcomes

  1. Clinical success rate

    Time frame: 3 months

    The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility

  2. Clinical success rate

    Time frame: 6 months

    The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility

  3. Clinical success rate

    Time frame: 12 months

    The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility

  4. Radiographic success rate

    Time frame: 3 months

    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

  5. Radiographic success rate

    Time frame: 6 months

    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. Radiographic success rate

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 20, 2018
Registry last updated
Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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