Clinical, Radiographic and Patient Acceptance Evaluation of LASER Compared to Formocresol Pulpotomies inPrimary Molars

NCT06200818 | Completed DMC

• 1 other identifier: FDASU-RecD061519
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial was to compare the clinical and radiographic success of laser versus formocresol pulpotomy in primary molars. The main questions it aimed to answer was:

• Does laser pulpotomy has higher clinical and radiographic success rate as formocresol pulpotomy in primary molars? Participants were selected according to eligibility criteria to undergo pulpotomy for their lower primary molars under local anesthesia using one of the following techniques:
• Group 1: Formocresol
• Group 2: Diode laser Group 3: Er:CrYSGG laser Clinical and radiographic follow up were performed for 18 months

Conditions

Pulpitis Reversible

Keywords

Pulp, vital pulp therapy, pulpotomy, formocresol, diode, erbium

Outcome Measures

Primary Outcomes (1)

• Clinical and radiographic success

  Clinical success criteria: 1. Restoration intact; 2. No pain or tenderness; 3. No mobility; 4. No swelling; 5. No fistula; 6. No gingival inflammation-represented by pain, redness, or bleeding-around the tooth/crown. Radiographic success at follow-up visits should meet the following criteria: 1\. No external root resorption; 2. No internal root resorption; 3. No inter-radicular bone resorption. 4. No Widening of the periodontal ligament space. 5. No periapical bone resorption.

  18 months

Study Arms (3)

Formocresol

ACTIVE COMPARATOR

Procedure: Formocresol

Diode laser

EXPERIMENTAL

Procedure: Diode laser

Er:CrYSGG

EXPERIMENTAL

Procedure: Er:CrYSGG

Interventions

Diode laser PROCEDURE

Diode laser

Er:CrYSGG PROCEDURE

Er:CrYSGG

Formocresol PROCEDURE

Formocresol

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. Clinical criteria One or more primary teeth indicated for pulpotomy due to carious pulp exposure. No spontaneous pain No swelling No tenderness to percussion No pathological mobility No sinus tract opening No initially unsuccessful hemorrhage control. 2. Radiographic criteria Teeth without inter-radicular radiolucency No loss of lamina dura or widened periodontal ligament space No physiologic root resorption of more than one-third.

You may not qualify if:

• Clinical mobility Spontaneous pain Swelling Tenderness to percussion Pathological mobility Non restorable teeth. Teeth with necrotic pulp. Pre-operative radiographic pathology such as resorption, periradicular or furcal radiolucency, a widened periodontal ligament space, or physiological root resorption of more than one-third. Parents / Patients not willing to be a part of the study. Any kind of medical history contraindicating the pulp treatment.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

Lasers, Semiconductor; formocresol

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Dina Hamdy

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of pediatric dentistry and dental public health

Study Record Dates

• First Submitted: December 31, 2023
• First Posted: January 11, 2024
• Study Start: December 20, 2015
• Primary Completion: December 30, 2017
• Study Completion: February 15, 2018
• Last Updated: January 11, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share