None listed
Conditions
Brief summary
This study will test whether a conservative treatment called full coronal pulpotomy can successfully save painful, deeply decayed adult teeth, even when some bleeding from the nerve tissue is deliberately allowed to continue before sealing the tooth. In this procedure, the dentist removes the inflamed nerve tissue from the crown of the tooth, places a modern bioactive cement over the remaining healthy pulp, and restores the tooth with a permanent filling, then reviews patients at 6 and 12 months to check pain levels, tooth function, and X-ray healing. The purpose is to see if this approach provides tooth survival and symptom relief that are not worse than those reported for conventional vital pulp therapy and standard root canal treatment, within a preplanned 10% margin. The study hypothesis is that allowing intentional uncontrolled bleeding (intentional uncontrolled haemostasis) during full coronal pulpotomy in these teeth will not lead to inferior 6 months or 12-month clinical and radiographic outcomes compared with published results for conventional vital pulp therapy and nonsurgical root canal treatment.
Interventions
Intervention
The intervention is full coronal pulpotomy with intentional uncontrolled haemostasis (IUH). This involves removing all inflamed pulp tissue from the crown portion of the tooth down to the root canal openings using a sterile diamond bur with water spray, deliberately not attempting to fully control bleeding before sealing.
Who Delivers It
The Vital Pulp Therapy (VPT) procedures are delivered by calibrated clinicians including endodontic registrars and Dental Officers who utilize mag
Intervention The intervention is full coronal pulpotomy with intentional uncontrolled haemostasis (IUH). This involves removing all inflamed pulp tissue from the crown portion of the tooth down to the root canal openings using a sterile diamond bur with water spray, deliberately not attempting to fully control bleeding before sealing. Who Delivers It The Vital Pulp Therapy (VPT) procedures are delivered by calibrated clinicians including endodontic registrars and Dental Officers who utilize magnification (loupes). All treating clinicians receive an education piece for calibration before performing the procedures. How It Is Delivered The treatment is delivered face-to-face as individual clinical care in a dental treatment setting. The procedure is performed under local anaesthetic with rubber dam isolation, involving: 1. Disinfection with 1% sodium hypochlorite 2. Decay removal and cavity preparation 3. Full coronal pulpotomy 4. Application of 2-4mm Biodentine (calcium-silicate cement) layer 5. Resin-modified glass ionomer layer 6. Permanent composite filling in the same visit Frequency and Duration The intervention is delivered as a single-visit treatment session (usually takes 45 mins to 1 hour). Follow-up assessment visits occur at 6 months and 12 months post-treatment, with a flexible window of approximately four weeks either side of the planned date. Where It Is Delivered The treatment is delivered at the Emergency Department, Westmead Oral Health Centre, Western Sydney Local Health District. Adherence Adherence is supported through: 1. Follow-up reminders: Participants who miss appointments are contacted by phone or letter and offered alternative times to encourage completion of follow-up 2. Monitoring: Scheduled review appointments at 6 and 12 months with standardized clinical and radiographic assessments 3. Adverse event tracking: All adverse events are recorded at scheduled and unscheduled visits
Sponsors
Western Sydney Local health district
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Age: 18-80 years Dentition: Permanent teeth with mature root (closed-root apex) Pulp Diagnosis: Moderate to severe pulpitis with clinical symptoms including: Moderate pulpitis: Heightened and prolonged reaction to cold lasting for minutes, possibly percussion sensitive, spontaneous dull pain that can be suppressed with pain medication Severe pulpitis: Severe spontaneous pain with clear pain reaction to warmth and cold stimuli, often sharp to dull throbbing pain, patients have trouble sleeping, tooth is sensitive to touch and percussion Caries Status: Deep or extremely deep cavity/carious lesions Sensibility Testing: Positive response to cold test (Endofrost) with lingering pain for at least 30 seconds Radiographic Status: X-ray may be normal or show slightly widened ligament space and/or a dark area at the root tip, as long as the pulp is still alive on testing and vital tissue is seen clinically Clinical Pulp Visualization: After pulpotomy, pulp tissue appears healthy and vital (uniformly red, bleeds, surrounded by hard non-infected dentine with no dentine chips left on the pulp) Restorability/Isolation: Tooth can be restored and isolated with rubber dam Previous Endodontics: No prior endodontic therapy on the study tooth Calcification: No severe calcifications in the root canal or pulp chamber Haemostasis Behavior: Bleeding continues for more than 30 seconds after pulpotomy (intentional uncontrolled haemostasis), confirmed via direct visual inspection under magnification
Exclusion criteria
Systemic Health: - Patients with immunosuppression - Patients with conditions significantly increasing risk of bleeding, such as congenital bleeding disorders - Pregnant patients
Outcome results
None listed