Low-level Laser Therapy Versus Formocresol in Primary Molar Pulpotomies

• ClinicalTrials.gov Identifier: NCT03782714
• Recruitment Status: Completed
• First Posted: December 20, 2018
• Last Update Posted: December 20, 2018
• Sponsor: King Abdulaziz University
• Information provided by (Responsible Party): Najlaa Alamoudi, King Abdulaziz University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pulpotomy	Device: Low-level laser therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: It is a split-mouth randomized controlled clinical trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical and Radiographic Evaluation of Low-level Laser Therapy in Human Primary Molar Pulpotomies: A Randomized Controlled Clinical Trial
• Actual Study Start Date: February 1, 2017
• Actual Primary Completion Date: February 1, 2018
• Actual Study Completion Date: February 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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:

   1. Normal periodontal ligament space
   2. No inter-radicular or periapical radiolucency
   3. 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:

   1. Normal periodontal ligament space
   2. No inter-radicular or periapical radiolucency
   3. 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:

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

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 8 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Saudi Arabia

King Abdulaziz University, Dental University Hospital

Jeddah, Saudi Arabia, 21589

Sponsors and Collaborators

King Abdulaziz University

More Information

• Responsible Party: Najlaa Alamoudi, Professor at the Pediatric Dentistry Department, King Abdulaziz University
• ClinicalTrials.gov Identifier: NCT03782714
• Other Study ID Numbers: Alaa Nadhreen
• First Posted: December 20, 2018
• Last Update Posted: December 20, 2018
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Najlaa Alamoudi, King Abdulaziz University:

Low-level laser therapy, pulpotomy, formocresol