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Diode Laser Pulpotomy of Mature Permanent Molars With Irreversible Pulpitis

Primary Purpose

Irreversible Pulpitis

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pulpotomy
Diode laser - fonalaser
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irreversible Pulpitis

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group I: Platelet rich Fibrin (PRF) and Biodentine

Group II: Diode Laser and Biodentine

Group III: Diode laser + PRF + Biodentine

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 12, 2022
Last Updated
June 19, 2022
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05427851
Brief Title
Diode Laser Pulpotomy of Mature Permanent Molars With Irreversible Pulpitis
Official Title
Effect Of Diode Laser And Platelet Rich Fibrin In Regenerative Pulpotomy Of Mature Permanent Molars With Irreversible Pulpitis (A Randomized Controlled Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irreversible Pulpitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I: Platelet rich Fibrin (PRF) and Biodentine
Arm Type
Experimental
Arm Title
Group II: Diode Laser and Biodentine
Arm Type
Experimental
Arm Title
Group III: Diode laser + PRF + Biodentine
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
pulpotomy
Intervention Description
coronal pulp tissue removal followed by radicular pulp hemostasis them applying a pulp capping material
Intervention Type
Device
Intervention Name(s)
Diode laser - fonalaser
Intervention Description
diode laser beam application
Primary Outcome Measure Information:
Title
regenerative pulpotomy success
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
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.
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Dentine bridge formation
Description
To evaluate the effect of Diode laser on the enhancement of dentin bridge formation following pulpotomy procedure using CBCT.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients between 18 and 40 years of age. Deep caries in a permanent lower molar with mature roots. Clinical diagnosis of symptomatic irreversible pulpitis No signs of pulpal necrosis including sinus tract or swelling. Vital bleeding pulp tissue should be present in all canals after complete pulpotomy. The tooth is restorable. Exclusion Criteria: Patients with systemic disease. Negative response to cold testing. Presence of sinus tract or swelling. No pulp exposure after caries excavation. Bleeding could not be controlled Absence of bleeding from any of the canals. Teeth with radiographic signs of internal resorption. Pulpal calcifications. Non-restorable teeth
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raef A sherif, PhD
Organizational Affiliation
Professor of Endodontics, Faculty of Dentistry, Alexandria University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

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Diode Laser Pulpotomy of Mature Permanent Molars With Irreversible Pulpitis

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