Five-year results of vital pulp therapy in permanent molars with irreversible pulpitis: a non-inferiority multicenter randomized clinical trial.
Saeed Asgary, Mohammad Jafar Eghbal, Mahta Fazlyab...
https://pubmed.ncbi.nlm.nih.gov/24771228/Actively Recruiting
Led by Semmelweis University · Updated on 2025-03-06
400
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are investigating the effectiveness of different vital pulp therapy VPT methodsdirect pulp capping, partial pulpotomy, and complete pulpotomyin preserving the vitality of dental pulp after pulp exposure. This observational prospective cohort study also explores how factors such as age influence treatment success, aiming to identify if there is an age threshold that affects the choice of VPT over root canal therapy. The study involves adult patients with restorable teeth and exposed pulp chambers, tracking outcomes over a period of up to four years. The study treatments begin with local anesthesia and isolation of the tooth, followed by disinfection and removal of caries under a microscope. Depending on the severity and extent of pulp inflammation, participants receive one of three VPT methods direct pulp capping, partial pulpotomy removing a small portion of pulp tissue, or complete pulpotomy removing all coronal pulp tissue. Materials such as Biodentine or MTA are applied to the pulp, followed by temporary and then permanent restorations. Treatments are delivered carefully with bleeding control steps and follow-up procedures at specified intervals. Participants will be monitored through clinical and radiological examinations at 7 days, 6 months, and annually up to 4 years after treatment. Data including patient complaints, clinical findings, and radiographs are recorded to assess success using standardized indexes. The study tracks healing and pulp vitality, measuring treatment success by combining patient symptoms with clinical and X-ray results. This thorough follow-up allows researchers to compare the success rates of different VPT methods and understand the influence of age and other factors on outcomes.
CONDITIONS
The Effect of Different Risk Factors on the Success Rate of VPT
M
Melinda Zs Polyák, DMD
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Semmelweis University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants receive one of three types of vital pulp therapy procedures (direct pulp capping, partial pulpotomy, or complete pulpotomy) according to clinical indications. After local anaesthesia and tooth isolation, the pulp is treated with either Biodentine or MTA. One week later, participants return for removal of temporary restoration and placement of permanent restoration.
2 visits (in-person): initial treatment and 1-week restoration visit
Duration - 4 years
Participants are monitored through clinical examinations and radiographs to assess treatment success and any changes in symptoms or tooth condition.
Visits at 7 days, 6 months, 1 year, 2 years, 3 years, and 4 years after treatment
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Saeed Asgary, Mohammad Jafar Eghbal, Mahta Fazlyab...
https://pubmed.ncbi.nlm.nih.gov/24771228/European Society of Endodontology (ESE) developed by:, H F Duncan, K M Galler...
https://pubmed.ncbi.nlm.nih.gov/30664240/Firas Elmsmari, Xavier-Fructuós Ruiz, Queralt Miró...
https://pubmed.ncbi.nlm.nih.gov/31515048/Semmelweis University
Lead Sponsor