Effectiveness of Pulpotomy in Carious First Permanent Molar
NCT ID: NCT06137391
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
96 participants
INTERVENTIONAL
2024-01-31
2025-12-31
Brief Summary
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The aim of this study is to evaluate the clinical and radiographic effectiveness of partial removal of pulp in deeply carious symptomatic PFM affected with MIH over 24 months.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MIH and irreversible pulpitis
Group I (n=48) diagnosed with MIH and irreversible pulpitis. Group I will be randomly equally allocated into Group I A (n=24): partial pulpotomy (PP) and Group I B (n=24): full pulpotomy (FP). If pulpal bleeding cannot be controlled within 6 minutes using cotton pellets soaked in 3% sodium hypochlorite, the allocated procedure will be abandoned. The pulpotomy agent to be used will be mineral trioxide aggregate (MTA) and teeth will be restored using a resin modified glass ionomer restoration (RMGIC).
Vital Pulp Therapy
The pulp is accessed after caries removal then the inflamed part of the pulp is excavated. After haemostasis is achieved, a pulpootmy medicament is used to coronally seal the remaining pulp tissue. In partial pulpotomy only part of the pulp chamber is excavated while in full pulpotomy the whole pulp chamber is excavated.
No MIH with irreversible pulpitis
Group II (n=48) diagnosed with irreversible pulpitis but not affected with MIH. Group II will be randomly equally allocated into Group II A (n=24): partial pulpotomy (PP) and Group II B (n=24): full pulpotomy (FP). If pulpal bleeding cannot be controlled within 6 minutes using cotton pellets soaked in 3% sodium hypochlorite, the allocated procedure will be abandoned. The pulpotomy agent to be used will be mineral trioxide aggregate (MTA) and teeth will be restored using a resin modified glass ionomer restoration (RMGIC).
Vital Pulp Therapy
The pulp is accessed after caries removal then the inflamed part of the pulp is excavated. After haemostasis is achieved, a pulpootmy medicament is used to coronally seal the remaining pulp tissue. In partial pulpotomy only part of the pulp chamber is excavated while in full pulpotomy the whole pulp chamber is excavated.
Interventions
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Vital Pulp Therapy
The pulp is accessed after caries removal then the inflamed part of the pulp is excavated. After haemostasis is achieved, a pulpootmy medicament is used to coronally seal the remaining pulp tissue. In partial pulpotomy only part of the pulp chamber is excavated while in full pulpotomy the whole pulp chamber is excavated.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least one deeply decayed first permanent molar, checked through periapical x-ray)
* Noncontributory medical history.
* The tooth should be showing irreversible pulpitis signs and symptoms.
* The tooth is restorable and probing pocket depth and mobility within normal limits.
* No signs of pulpal necrosis including sinus tract or swelling.
Exclusion Criteria
* Negative response to cold testing.
* Presence of sinus tract or swelling.
* No pulp exposure after caries excavation.
* Bleeding could not be controlled after partial pulpotomy in 6 minutes.
* Insufficient bleeding after pulp exposure; the pulp is judged necrotic or partially necrotic.
* History of analgesic intake 3 days prior to the day of commencement of procedure.
7 Years
13 Years
ALL
Yes
Sponsors
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Alexandria University
OTHER
Responsible Party
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Rodaina Helmy
Assistant Lecturer, Pediatric dentistry department, Faculty of dentistry
Principal Investigators
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Rodaina H. Helmy
Role: PRINCIPAL_INVESTIGATOR
AlexU
Central Contacts
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Other Identifiers
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0775-09/2023
Identifier Type: -
Identifier Source: org_study_id