Randomized-controlled and Non-controlled Intervention Trial: Treatment of Deep Carious Lesions in Permanent Molars
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 249
- Primary Endpoint
- Number of patients without mobile teeth
Study Overview
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 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.
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-controlled clinical non-inferiority trial:
Teeth with reversible pulpitis will be included accordingly to the inclusion criteria (see below). After randomization, teeth will be treated either with selective caries removal (indirect pulp capping) or partial pulpotomy pursuant to the below described clinical protocol. The intention of this study arm is to evaluate both therapies.
Arm B: Prospective non-controlled clinical intervention trial
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Every patient has to give informed consent for participating in one of both study arms. To avoid clustering, only one tooth per patient can be included. Arm A is designed as a randomized-controlled and arm B as a non-controlled intervention trial.
The intervention in study arm B will be conducted adapted to the clinical findings after entering slightly the pulp chamber. Depending on the pulpal bleeding time, either a partial pulpotomy or a full pulpotomy will be conducted, according to the predefined protocol mentioned in "treatment protocol for arm A". Due to the experimental design, only single blinding of the patient is feasible.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 rarefaction
- •Partial or full crown restauration in situ
- •Tooth is non-restorable
- •Diagnosis: Irreversible pulpitis
Outcomes
Primary Outcomes
Number of patients without mobile teeth
Time Frame: 36 months
Tooth mobility testing with two fingers according to the tooth mobility score (0-III)
Number of patients with positive reaction to cold testing
Time Frame: 36 months
Tooth sensibility with endo coldspray (-40°C) (positive or negative reaction of the patient)
Number of patients with negative reaction to percussion testing
Time Frame: 36 months
Percussion testing of the treated tooth: backside of dental mirror (tenderness to percussion or no tenderness to percussion)
Number of patients with periodontal probing depths within normal limits
Time Frame: 36 months
Probing depths with a periodontal probe in mm
Number of patients with negative reaction to palpation testing
Time Frame: 36 months
Palpation testing with a finger and little pressure (tenderness to palpation or no tenderness to palpation)
Number of Patients without clinical signs of inflammation
Time Frame: 36 months
Screening the oral mucosa for swelling, fistula and erythema
Secondary Outcomes
- Number of patients with a PAI score of I - II(36 months)
Investigators
Falk Schwendicke
Head of the Department for Oral Diagnostics, Digital Health and Health Services Research
Charite University, Berlin, Germany