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)
1 other identifier
interventional
36
1 country
1
Brief Summary
Thirty six patients are included in this study. For each patient, a pulpotomy procedure is performed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2019
Longer than P75 for not_applicable
1 active site
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
April 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedFirst Submitted
Initial submission to the registry
June 12, 2022
CompletedFirst Posted
Study publicly available on registry
June 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedJune 22, 2022
June 1, 2022
2.1 years
June 12, 2022
June 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Postoperative pain
7 days
Other Outcomes (1)
Dentine bridge formation
12 months
Study Arms (3)
Group I: Platelet rich Fibrin (PRF) and Biodentine
EXPERIMENTALGroup II: Diode Laser and Biodentine
EXPERIMENTALGroup III: Diode laser + PRF + Biodentine
EXPERIMENTALInterventions
coronal pulp tissue removal followed by radicular pulp hemostasis them applying a pulp capping material
diode laser beam application
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry, Alexandria University
Alexandria, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Raef A sherif, PhD
Professor of Endodontics, Faculty of Dentistry, Alexandria University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2022
First Posted
June 22, 2022
Study Start
April 10, 2019
Primary Completion
May 1, 2021
Study Completion
September 1, 2022
Last Updated
June 22, 2022
Record last verified: 2022-06