Status:
UNKNOWN
Treatment of Deep Carious Lesions With Selective Caries Removal, Partial or Full Pulpotomy
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Septodont
3M
Conditions:
Irreversible Pulpitis
Reversible Pulpitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 pul...
Detailed Description
Goals of the study In consequence, the investigators aim to proof the effectiveness of different therapies and protocols in two study arms, depending on the initial diagnosis: Arm A: Randomized-cont...
Eligibility Criteria
Inclusion
- 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
- 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 rarefaction
- Partial or full crown restauration in situ
- Tooth is non-restorable
- Diagnosis: Irreversible pulpitis
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT04807244
Start Date
April 1 2021
End Date
September 30 2025
Last Update
March 19 2021
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