Diode Laser Pulpotomy of Mature Permanent Molars With Irreversible Pulpitis

Effect Of Diode Laser And Platelet Rich Fibrin In Regenerative Pulpotomy Of Mature Permanent Molars With Irreversible Pulpitis (A Randomized Controlled Clinical Trial)

Thirty six patients are included in this study. For each patient, a pulpotomy procedure is performed.

Study Overview

• Status: Active, not recruiting
• Conditions: Irreversible Pulpitis
• Intervention / Treatment: Procedure: pulpotomy; Device: Diode laser - fonalaser

Detailed Description

For each patient, a pulpotomy procedure is done. Group I (n=12) pulpotomy is performed and hemostasis is achieved by applying NaOCl, then the radicular pulp is covered with Platelet Rich Fibrin (PRF) and capped with Biodentine, Group II (n=12) pulpotomy is done as in group I and hemostasis is achieved using diode laser and remaining pulp is capped with Biodentine, Group III (n=12) pulpotomy is performed and hemostasis is achieved as in group II then radicular pulp is covered with PRF then capped with Biodentine, The teeth are then restored with Glass ionomer cement followed by composite restoration. Pain is recorded every 24 hours for 7 days after intervention. Clinical and radiographic follow-up are done at 1,3,6,9 and 12 months. Cone beam computed tomography (CBCT) is done immediate postoperative and will be used for the assessment of the outcome of the pulpotomy procedure at the end of the study period.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients between 18 and 40 years of age.
2. Deep caries in a permanent lower molar with mature roots.
3. Clinical diagnosis of symptomatic irreversible pulpitis
4. No signs of pulpal necrosis including sinus tract or swelling.
5. Vital bleeding pulp tissue should be present in all canals after complete pulpotomy.
6. The tooth is restorable.

Exclusion Criteria:

1. Patients with systemic disease.
2. Negative response to cold testing.
3. Presence of sinus tract or swelling.
4. No pulp exposure after caries excavation.
5. Bleeding could not be controlled
6. Absence of bleeding from any of the canals.
7. Teeth with radiographic signs of internal resorption.
8. Pulpal calcifications.
9. Non-restorable teeth

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I: Platelet rich Fibrin (PRF) and Biodentine	Procedure: pulpotomy; coronal pulp tissue removal followed by radicular pulp hemostasis them applying a pulp capping material
Experimental: Group II: Diode Laser and Biodentine	Procedure: pulpotomy; coronal pulp tissue removal followed by radicular pulp hemostasis them applying a pulp capping material; Device: Diode laser - fonalaser; diode laser beam application
Experimental: Group III: Diode laser + PRF + Biodentine	Procedure: pulpotomy; coronal pulp tissue removal followed by radicular pulp hemostasis them applying a pulp capping material; Device: Diode laser - fonalaser; diode laser beam application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
regenerative pulpotomy success	Assessing the clinical and radiographic success rate of the regenerative pulpotomy. • Teeth were considered as clinical success if patients had lack of pain (spontaneous or on chewing), sinus tract or swelling, pathological mobility, and had intact coronal restoration.( procedure done in permanent mature teeth with irreversible pulpitis. Treatment was considered radiographically successful if no pathosis was evident on the recall radiograph such as root resorption, no furcal or periapical rarefaction. Periapical Index (PAI) was used to evaluate the periapical tissue condition by comparing the pre-operative radiographs with the follow-up radiographs.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	To evaluate the effect of Diode laser on decreasing the immediate postoperative pain. Postoperative pain was recorded on Numerical Rating Pain Scale (NRS) that was given to the patient in Arabic language to record his pain experience every 24 hours until the seventh day after the first appointment. Pain on the NRS was further categorized as:(0)no pain, (1-3) mild, (4-6) moderate, (7-10) Severe pain.	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dentine bridge formation	To evaluate the effect of Diode laser on the enhancement of dentin bridge formation following pulpotomy procedure using CBCT.	12 months

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Director: Raef A sherif, PhD, Professor of Endodontics, Faculty of Dentistry, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2019
• Primary Completion (Actual): May 1, 2021
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: June 12, 2022
• First Submitted That Met QC Criteria: June 19, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 19, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis
• Other Study ID Numbers: Darinemamdouh

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes