The management of deep carious lesions and the exposed pulp amongst members of two European endodontic societies: a questionnaire-based study.
R Careddu, G Plotino, E Cotti...
https://pubmed.ncbi.nlm.nih.gov/32970860Actively Recruiting
Age: 18Years +
All Genders
ID06918639
Effectiveness of Pulpotomy in Symptomatic Permanent Teeth With Deep Caries Lesions
Led by Universidad Rey Juan Carlos · Updated on 2025-04-09
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the success of partial or complete pulpotomy treatments in adults with permanent teeth affected by deep caries lesions and symptoms of irreversible pulpitis. The study aims to preserve pulp tissue to maintain its natural functions and reduce tooth weakening compared to root canal treatment, which is more complex and time-consuming. This observational study also seeks to understand factors related to patients, treated teeth, and specific treatments that may influence pulpotomy success, along with measuring patient satisfaction. The treatments involve either partial pulpotomy, where about 2 mm of pulp tissue is removed, or full pulpotomy, which completely removes tissue from the pulp chamber. Hemostasis is achieved using sodium hypochlorite within 10 minutes, and a material called BiodentineXp is applied. Both types of pulpotomies are performed by the principal investigator in a single appointment, including the definitive restoration of the tooth. The choice between partial or total pulpotomy is made clinically during treatment rather than randomized. Participants will undergo clinical and radiographic examinations before treatment and evaluations at 1 week, 3 months, 6 months, and 12 months afterward. These follow-ups will be conducted by an examiner other than the treating clinician. Success is defined by the absence of symptoms and pathological radiographic signs indicating pulp disease. Patient perception and satisfaction with the treatment will also be surveyed. The main outcome measured is the success rate of vital pulp therapy over one year, and patient satisfaction is assessed shortly after treatment.
CONDITIONS
Brief Title
Effectiveness of Pulpotomy in Symptomatic Permanent Teeth With Deep Caries Lesions
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age
- Patients in good general health, ASA I or ASA II, with no contraindications to local anesthesia
- Tooth with symptoms of pulpitis (reversible or irreversible) confirmed by spontaneous pain and cold test
- Tooth without pulp necrosis, sinus tract, or abscess
- Tooth in occlusion with antagonist tooth and no chewing discomfort
- Tooth that can be directly restored
- Tooth with normal pocket depth and mobility
- Caries lesion extending more than two thirds of the amelodentine distance or pulp exposed during caries removal
You will not qualify if you...
- Allergy or intolerance to any anesthetic solution
- Pregnant or suspect pregnancy due to inability to perform radiographic tests
- Systemic diseases preventing vasoconstrictor use or compromised immune system
- Tooth with immature apex
- Tooth not restorable or not viable for preservation
- Tooth with negative thermal or electrical sensitivity tests
- Inability to achieve haemostasis within 10 minutes or absence of pulp bleeding or tissue necrosis observed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single treatment visit
Participants receive pulpotomy treatment, either partial or full, to treat symptomatic permanent teeth with deep caries lesions.
1 visit (in-person)
Follow-up
Duration - Up to 1 year
Participants are monitored for treatment success and patient satisfaction, including an initial control visit and follow-up to one year.
1 control visit 7 days after treatment and additional follow-up visits until 1 year
Trial Site Locations
Total: 1 location
1
Rey Juan Carlos University
Alcorcón, Madrid, Spain, 28922
Actively Recruiting
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Research Team
O
OLGA GONZÁLEZ-CASTRO, DDS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Minimally invasive endodontics: a new diagnostic system for assessing pulpitis and subsequent treatment needs.
W J Wolters, H F Duncan, P L Tomson...
https://pubmed.ncbi.nlm.nih.gov/28776717Comparative evaluation of complete and partial pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis: A randomized clinical trial.
Ankita Ramani, Pankaj Sangwan, Sanjay Tewari...
https://pubmed.ncbi.nlm.nih.gov/35226769Outcome of partial and full pulpotomy in cariously exposed mature molars with symptoms indicative of irreversible pulpitis: A randomized controlled trial.
Ashima Jassal, Ruchika Roongta Nawal, Seema Yadav...
https://pubmed.ncbi.nlm.nih.gov/36403208Pulpectomy vs. Pulpotomy as Alternative Emergency Treatments for Symptomatic Irreversible Pulpitis-A Multicenter Comparative Randomised Clinical Trial on Patient Perceptions.
Guillem Esteve-Pardo, Pedro Barreiro-Gabeiras, Lino Esteve-Colomina
https://pubmed.ncbi.nlm.nih.gov/37623263Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting.
Reinhard Hickel, Sabine Mesinger, Niek Opdam...
https://pubmed.ncbi.nlm.nih.gov/36504246Outcome of full pulpotomy using Biodentine in adult patients with symptoms indicative of irreversible pulpitis.
N A Taha, S Z Abdelkhader
https://pubmed.ncbi.nlm.nih.gov/293970034-Year Follow-up of Full Pulpotomy in Symptomatic Mature Permanent Teeth with Carious Pulp Exposure Using a Stainproof Calcium Silicate-based Material.
Nessrin A Taha, Hanan Al-Khatib
https://pubmed.ncbi.nlm.nih.gov/34563506A Randomized Controlled Clinical Trial of Pulpotomy versus Root Canal Therapy in Mature Teeth with Irreversible Pulpitis: Outcome, Quality of Life, and Patients' Satisfaction.
Nessrin A Taha, Alaa M Abuzaid, Yousef S Khader
https://pubmed.ncbi.nlm.nih.gov/37080387Vital pulp therapy: histopathology and histobacteriology-based guidelines to treat teeth with deep caries and pulp exposure.
Domenico Ricucci, José F Siqueira, Yuanyuan Li...
https://pubmed.ncbi.nlm.nih.gov/31121241