Treatment of Deep Carious Lesions With Selective Caries Removal, Partial or Full Pulpotomy (NCT04807244) | Clinical Trial Compass
UnknownNot Applicable
Treatment of Deep Carious Lesions With Selective Caries Removal, Partial or Full Pulpotomy
249 participantsStarted 2021-04-01
Plain-language summary
The optimal treatment of deep caries lesions extended to the inner third of dentin is still under discussion. Cariologists prefer selective caries removal, meanwhile endodontists recommend partial pulpotomy. So far, no clinical trial compared both interventions against each other. Additionally, current literature indicates alternative treatment options for irreversible pulpitis besides conventional orthograde root canal treatments like the partial or full pulpotomy. Existing clinical studies on this topic were using different clinical protocols, especially with regards to the accepted time to achieve hemostasis. It is still unclear, if the pulpal bleeding time prior to the capping procedure affects the outcome of partial or full pulpotomy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 18 a Health status
* No contributory systemic diseases with influence to the immune system or coagulation system
Tooth-related factors
* Type: Permanent molars
* Mature roots
* Caries extended to \>2/3 of dentin and expected pulp exposure performing non-selective caries removal (Only study arm "partial pulpotomy": Pulp exposure after non-selective caries removal)
* Sensibility: +/++; prolonged \<5s
* Pain only on stimulus (hot/cold) and not prolonged or no pain
* No tenderness to palpation
* No tenderness to percussion
* Periodontal probing depth \<4 mm
* No pathologic tooth mobility
* No swelling
* No fistula
* No swelling
* Radiograph: Periapical status with physiological appearance (PAI Score I or II)
* No partial/full crown restauration
* Tooth has to be restorable
* Pulpal diagnosis reversible pulpitis
Exclusion Criteria:
* Age \< 18 a
* Health status with above mentioned contributory diseases (immunosuppression, or diseases related to the coagulation system)
* Deciduous teeth
* Immature roots
* Caries extending less than \<2/3 of dentin
* (Only study arm "partial pulpotomy": No pulp exposure after non-selective caries removal)
* Tooth sensibility +++ or prolonged \> 5 s
* Severe pain, prolonged on stimulus (hot/cold), dull, throbbing, spontaneous pain
* Tenderness to palpation +
* Periodontal probing depth \>3 mm
* Tooth mobility grade \>Score I
* Swelling present
* Fistula present
* Radiograph: Apical periodontitis or apical rarefactio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients with positive reaction to cold testing
Timeframe: 36 months
2
Number of patients without mobile teeth
Timeframe: 36 months
3
Number of patients with negative reaction to palpation testing
Timeframe: 36 months
4
Number of patients with negative reaction to percussion testing
Timeframe: 36 months
5
Number of patients with periodontal probing depths within normal limits
Timeframe: 36 months
6
Number of Patients without clinical signs of inflammation