Low-level Laser Therapy Versus Formocresol in Primary Molar Pulpotomies

NCT03782714 | Completed DMC

• 1 other identifier: Alaa Nadhreen
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulpotomy

Keywords

Low-level laser therapy, pulpotomy, formocresol

Outcome Measures

Primary Outcomes (6)

• 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: 1. Normal periodontal ligament space 2. No inter-radicular or periapical radiolucency 3. No internal or external root resorption

  3 months

• Radiographic success rate

  The 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

  6 months

• Radiographic success rate

  The 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

  12 months

Study Arms (2)

Low-level laser therapy group

EXPERIMENTAL

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

Device: Low-level laser therapy

Formocresol group

NO INTERVENTION

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

Interventions

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

Low-level laser therapy group

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University, Dental University Hospital

Jeddah, 21589, Saudi Arabia

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor at the Pediatric Dentistry Department

Model Details: It is a split-mouth randomized controlled clinical trial

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: December 20, 2018
• Study Start: February 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)