Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02629042
Other study ID # CHUBX 2014/09
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 15, 2017
Est. completion date December 3, 2018

Study information

Verified date December 2018
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Irreversible pulpitis is an inflammatory condition of the dental pulp, highly painful, representing one of the main reasons for consulting dental emergency. The recommended emergency care is a partial endodontic treatment under local and/or locoregional anesthesia. The purpose of the emergency partial endodontic treatment is to stop the pain of pulpitis by removing a portion of the pulp. The final endodontic treatment is ideally performed 72 hours after. The literature reports major difficulty in obtaining adequate anesthesia in the mandible to perform partial endodontic treatment, especially for the mandibular molars. This results in a very painful care for the patient. The management of this type of emergency is costly in terms of equipment and time for health facilities. Patient comfort, cost saving and rationalization of the care time justify the search for an alternative to emergency partial endodontic treatment. In current practice, the short course oral corticotherapy is used in the management of oral pain from inflammatory origin. Glucocorticoids, thanks to their anti-inflammatory action, can neutralize the inflammatory mediators and thus pain. The pulp inflammation can be treated with this molecule: the effectiveness of intraosseous local steroid injection for irreversible pulpitis of mandibular molars has already been shown but results in local comorbidities and requires specific device. Oral administration of short-course prednisolone is simple and safe but its effectiveness to manage pain caused by irreversible pulpitis has not yet been demonstrated. Per-os administration of prednisolone has a very high (90%) and rapid (≤ 4 hours) bioavailability. No difference in effectiveness between intravenous and oral administration of this molecule was reported. This oral treatment could limit comorbidities and technical difficulties related to intraosseous injection and could delay the endodontic treatment to 72 hours in optimal conditions of anesthesia for the patient. Despite the difficulties described for the partial endodontic treatment, it is very effective in pain reduction and can reach 100% of success. Therefore a non-inferiority design was chosen to compare the effect of a short-course oral corticotherapy to a partial endodontic treatment for the reduction of pain at the emergency care of the irreversible pulpitis in mandibular molars. The intervention arm will receive an oral dose of prednisolone (1 mg/kg) during the emergency visit followed-up by one morning dose by day during three days and the reference arm will have partial endodontic treatment. Both groups will have planned complete endodontic treatment 72 hours after enrolment.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date December 3, 2018
Est. primary completion date November 28, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Clinical signs of irreversible pulpitis on a mandibular molar,

- ASA1 or ASA2 score (American Society of Anesthesiologists)

- Age between 18 and 70 years (of either gender)

- Ability to give written informed consent

- Affiliation to a health insurance scheme

- Agreement to be contacted by phone 24h after the emergency visit

- Availability to come back 72 hours after the emergency visit for endodontic treatment

Exclusion Criteria:

- Diagnosis of reversible pulpitis, acute apical periodontitis, periodontal lesion of endodontic origin or dentin syndrome

- Not retainable tooth requiring extraction

- Contraindication of endodontic treatment (endocarditis risk) or local anaesthesia

- Contraindication for the prescription of glucocorticoids, paracetamol or codeine,

- Oral infection, viral disease in evolution (hepatitis, herpes zoster, .. ),

- Machine operators ,

- Psychosis uncontrolled by treatment, or chronic consumption of drugs or alcohol

- Allergy to one or more of the components,

- Diabetes, drug intake with direct interaction with glucocorticoids, paracetamol or codeine,

- Woman of child-bearing age without contraceptive, pregnancy, breastfeeding

- Not able to give informed consent,

- Participating in another interventional study

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Partial endodontic treatment under local and/or locoregional anesthesia
The reference management consists in local and locoregional anesthesia of the molar and partial endodontic treatment. At the end of the emergency visit, all the patients, whatever their randomization group, will be given two types of antalgics and will be recommended to take them only if they have pain. Seventy-two hours after, all the patients, whatever their randomization will have endodontic treatment under local and locoregional anesthesia.
Drug:
prednisolone
The evaluated intervention consists in per-os administration of prednisolone (1 mg / kg) during the emergency visit followed-up by one morning dose by day during three days. At the end of the emergency visit, all the patients, whatever their randomization group, will be given two types of antalgics and will be recommended to take them only if they have pain. Seventy-two hours after, all the patients, whatever their randomization will have endodontic treatment under local and locoregional anesthesia.

Locations

Country Name City State
France CHU de Bordeaux Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity on a numeric scale 24 hours after the emergency visit (inclusion)
Secondary The number of antalgic drugs taken after the emergency visit 72 hours after the emergency visit (inclusion)
Secondary The number of patients coming back to consultation at 72h 72 hours after the emergency visit (inclusion)
Secondary The number of injected anesthetic cartridges when performing the endodontic treatment 72 hours after the emergency visit (inclusion)
Secondary Patient's comfort evaluation during the endodontic treatment using a questionnaire with numeric scales 72 hours after the emergency visit (inclusion)
See also
  Status Clinical Trial Phase
Unknown status NCT00972556 - Comparison of Mineral Trioxide Aggregate (MTA) and 20% Formocresol (FC) in Pulpotomized Human Primary Molars N/A
Completed NCT04126928 - Validation of PUFA Index in Assessing Untreated Dental Caries Among Malaysian Adult Subpopulation N/A
Completed NCT02967081 - Evaluation of Dentinal Fluid for the Presence of Matrix Metalloproteinase 9 (MMP-9) in Pulpal Inflammation
Recruiting NCT02745782 - A Study of the Trigeminal Cardio-Reflex in Endodontic and Other Dental Treatment N/A
Completed NCT02681276 - Clinical and Microbiological Evaluation of 0.5% Versus 3% Sodium Hypochlorite in Root Canal Treatment N/A
Completed NCT03490422 - Pulpotomy in Carious Permanent Mature Teeth: Pulp Survival and Risk Factors N/A
Completed NCT06152354 - Efficacy of Pediatric Rotary File System Versus Hand Instrumentation for Root Canal Preparation in Primary Teeth N/A
Completed NCT02940704 - Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems N/A
Completed NCT02566486 - Postoperative Pain Intensity After Using Different Instrumentation Techniques: a Randomized Clinical Study N/A
Completed NCT03168620 - Effect of Glass Ionomer Cement as an Interim Restoration in Diagnosis of Pulpal Status N/A
Completed NCT05476445 - Effect of Cryotherapy and LLLT on Postoperative Pain After Root Canal Treatment N/A
Completed NCT04331964 - The Use of Platelet-Rich Fibrin in Partial Pulpotomy Procedure N/A
Completed NCT04115358 - Evaluation of Hyaluronic Acid Pulpotomies in Primary Molars N/A
Completed NCT03807674 - MMP-9 Expression in Permanent Mature Teeth With Symptomatic Pulpitis N/A
Completed NCT01530217 - Assessing of Tooth Sensitivity Using Ibuprofen Before in Office-tooth Bleaching N/A
Completed NCT05239078 - Comparative Evaluation of Pulpal Anaesthetic Efficacy of Different Anaesthetic Solutions for Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis N/A
Completed NCT02494193 - Indirect Pulp Capping With Resin Modified Glass Ionomer N/A
Completed NCT02819648 - Oral Glucocorticoids Effect on Post Endodontic Pain Phase 4
Completed NCT01420718 - Partial Pulpotomy on Caries Free Human Teeth Phase 2/Phase 3
Completed NCT04385693 - Intentional Pulpotomy to Preserve Hopeless Molars N/A