NCT06176378

Brief Summary

In this study, patients with symptoms of irreversible pulpitis in mature permanent molars were treated with two pulpotomies techniques after random allocation in either 2 groups: Diode laser pulpotomy and traditional pulpotomy using bioactive materials (retro mineral trioxide aggregate ) with each group.The null hypothesis of the study was there would be no difference in success rate between Diode laser and traditional methods of adult pulpotomy .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 19, 2023

Completed
Last Updated

December 26, 2023

Status Verified

December 1, 2023

Enrollment Period

2.4 years

First QC Date

December 10, 2023

Last Update Submit

December 19, 2023

Conditions

Irreversible PulpitisEndodontic Inflammation

Keywords

Full pulpotomyLow-level Diode Laser

Outcome Measures

Primary Outcomes (1)

  • Assessment of success or failure

    Assessment of success or failure was done using the technique described by Galeni et al Treatment was considered successful if the patient's final restoration was intact and the patient demonstrated no clinical symptoms (pain (spontaneous or on chewing), swelling, or sinus tract), and had a periapical index score of 1. • Treatment was considered uncertain if the patient's final restoration was intact, and the patient demonstrated no clinical symptoms (pain (spontaneous or on chewing), swelling, or sinus tract), and a PAI score of 2. • Treatment was considered a failure in the following situations: 1\. Any case in which the final restoration was not intact. Irrelevant clinical and radiographic symptoms. 2\. Any case in which the final restoration was intact and the patient demonstrated clinical symptoms. Irrelevant of PAI score. 3\. Any case in which the final restoration was intact and the patient had a PAI score of 3 or above. Irrelevant of clinical symptoms.

    (T1): 1 week postoperative, (T2): after 6 months, (T3): after 12 months, and (T4) after 18 months.

Study Arms (2)

Traditional Pulpotomy procedures

EXPERIMENTAL

In the traditional pulpotomy group, the coronal pulp was removed by the traditional method the the capping material applied

Other: traditional pulpotomy

Diode laser Pulpotomy procedures

EXPERIMENTAL

in the low-level diode laser pulpotomy group, the radicular pulp was biostimulated using low-level diode laser before application of capping material

Device: diode laser pulpotomy

Interventions

traditional pulpotomyOTHER

After complete deroofing, the coronal pulp was amputated to the level of the orifice using a high-speed size #2 round bur followed by rinsing the pulp chamber thoroughly with 5ml 0.9% saline solution.Hemostasis was then achieved by placing a sterile cotton pellet moistened with saline in the access cavity for 6 min.Retro MTA capping material was then applied,

Also known as: full pulpotomy
Traditional Pulpotomy procedures
diode laser pulpotomyDEVICE

after establishing hemostasis, low-level laser energy at (970nm, power .5W, duty cycle 50%, and frequency 5H) was applied to each pulp stump for 10 sec. through 320 microns optical fiber tip . The laser was used in pulsed non-contact mode at the level of the occlusal surface of the tooth.Retro MTA capping material was then applied,

Also known as: laser biostimulation
Diode laser Pulpotomy procedures

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • permanent 1st and 2nd molar
  • irreversible pulpitis
  • restorable

You may not qualify if:

  • Non-restorable teeth.
  • Teeth with buccal restoration.
  • Non-vital teeth that are not responsive to thermal stimuli or electric pulp test.
  • Presence of swelling or sinus tracts.
  • Teeth which showed sensitivity to percussion.
  • Teeth with grade Ⅱ and Ⅲ mobility.
  • Teeth with immature apices.
  • Teeth with internal or external resorption or teeth with periapical pathosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University

Cairo, 11651, Egypt

Location

MeSH Terms

Conditions

Pulpitis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator/Assistant Lecturer

Study Record Dates

First Submitted

December 10, 2023

First Posted

December 19, 2023

Study Start

October 12, 2020

Primary Completion

March 14, 2023

Study Completion

March 14, 2023

Last Updated

December 26, 2023

Record last verified: 2023-12

Locations

EG(1)