Back to resultsAssessment of Pain and Treatment Success After VPT Versus RCT in Mature Permanent Mandibular Molars With SIP: A RCT
Primary Purpose
Symptomatic Irreversible Pulpitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Root canal treatment
Vital pulp therapy
Sponsored by
About this trial
This is an interventional treatment trial for Symptomatic Irreversible Pulpitis focused on measuring SIP
Eligibility Criteria
Inclusion Criteria: Systemically healthy patients. Patient's age range more than 15 years. Mature permanent mandibular molars with deep caries. Clinical diagnosis of symptomatic irreversible pulpitis. Teeth with no need for the post. Healthy periodontium and mobility within normal limits. Patients who can understand the pain scale and can sign the informed consent Exclusion Criteria: Teeth with a negative response to vitality testing. Teeth with furcal bone loss. Teeth with sinus tract Teeth with swelling. Teeth with a non-restorable crown. Teeth with immature roots. Teeth with no pulp exposure even after caries excavation. History of analgesic intake in the previous week. History of antibiotic intake in the previous month. Insufficient bleeding after pulp exposure suggestive of partial necrosis of the pulp. Inability to control bleeding within 10 min. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Root canal treatment
Vital pulp therapy
Arm Description
after access cavity preparation, the working length will be determined. chemo-mechanical preparation will be done, and teeth will be obturated. final restoration will be placed.
exposed pulp will be capped with 3 mm calcium silicate material
Outcomes
Primary Outcome Measures
Postoperative pain
postoperative pain will be recorded by patient using NRS
Secondary Outcome Measures
Intensity of postoperative pain
postoperative pain will be recorded by patient using NRS
Treatment success
clinical and radiographic success
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05681494
Brief Title
Assessment of Pain and Treatment Success After VPT Versus RCT in Mature Permanent Mandibular Molars With SIP: A RCT
Official Title
Assessment of Postoperative Pain and Treatment Success After Vital Pulp Therapy Versus Root Canal Treatment in Mature Permanent Mandibular Molars With Irreversible Pulpitis: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 26, 2023 (Anticipated)
Primary Completion Date
July 26, 2023 (Anticipated)
Study Completion Date
June 26, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assessment of postoperative pain and treatment success after vital pulp therapy versus root canal treatment in mandibular molar with signs and symptoms of irreversible pulpitis. the null hypothesis, there is no difference will be observed in the pain level and treatment success between two treatments.
Detailed Description
After proper clinical and radiographic examination. Teeth will be anesthetized and isolated using a rubber dam. The operative field will be disinfected. Total caries removal will be done from outside making margin caries free to inside. the new diamond bur will be used to remove the last layer and exposed the pulp tissue. Exposed pulp will be inspected under a dental operating microscope and hemostasis will be obtained. The teeth will be randomized into 2 intervention groups (VPT or RCT). Treatment will be finalized, and teeth will be restored with resin-modified glass ionomer followed by composite resin at the same appointment. Ibuprofen 400mg will be prescribed to the patient if needed. Patients will be asked to record postoperative pain after treatment on the pain score sheet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Irreversible Pulpitis
Keywords
SIP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Root canal treatment
Arm Type
Active Comparator
Arm Description
after access cavity preparation, the working length will be determined. chemo-mechanical preparation will be done, and teeth will be obturated. final restoration will be placed.
Arm Title
Vital pulp therapy
Arm Type
Experimental
Arm Description
exposed pulp will be capped with 3 mm calcium silicate material
Intervention Type
Procedure
Intervention Name(s)
Root canal treatment
Other Intervention Name(s)
RCT, Full pulpectomy
Intervention Description
after access cavity preparation, the working length will be determined. chemo-mechanical preparation will be done, and teeth will be obturated. final restoration will be placed.
Intervention Type
Procedure
Intervention Name(s)
Vital pulp therapy
Other Intervention Name(s)
pulpotomy
Intervention Description
exposed pulp will be capped with 3 mm calcium silicate material
Primary Outcome Measure Information:
Title
Postoperative pain
Description
postoperative pain will be recorded by patient using NRS
Time Frame
at 6 hours postoperative
Secondary Outcome Measure Information:
Title
Intensity of postoperative pain
Description
postoperative pain will be recorded by patient using NRS
Time Frame
at 24, 48 hours and 7 days
Title
Treatment success
Description
clinical and radiographic success
Time Frame
at 3,6,12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Systemically healthy patients.
Patient's age range more than 15 years.
Mature permanent mandibular molars with deep caries.
Clinical diagnosis of symptomatic irreversible pulpitis.
Teeth with no need for the post.
Healthy periodontium and mobility within normal limits.
Patients who can understand the pain scale and can sign the informed consent
Exclusion Criteria:
Teeth with a negative response to vitality testing.
Teeth with furcal bone loss.
Teeth with sinus tract
Teeth with swelling.
Teeth with a non-restorable crown.
Teeth with immature roots.
Teeth with no pulp exposure even after caries excavation.
History of analgesic intake in the previous week.
History of antibiotic intake in the previous month.
Insufficient bleeding after pulp exposure suggestive of partial necrosis of the pulp.
Inability to control bleeding within 10 min.
Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amany IA mohamed, phd
Phone
01099300346
Ext
002
Email
amany.ahmed@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed S Elsheshtawy
Organizational Affiliation
Lecturer, Department of Endodontics, Faculty of Dentistry, Cairo university.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
35152464
Citation
Taha NA, Al-Rawash MH, Imran ZA. Outcome of full pulpotomy in mature permanent molars using 3 calcium silicate-based materials: A parallel, double blind, randomized controlled trial. Int Endod J. 2022 May;55(5):416-429. doi: 10.1111/iej.13707. Epub 2022 Mar 17.
Results Reference
background
PubMed Identifier
34205149
Citation
Santos JM, Pereira JF, Marques A, Sequeira DB, Friedman S. Vital Pulp Therapy in Permanent Mature Posterior Teeth with Symptomatic Irreversible Pulpitis: A Systematic Review of Treatment Outcomes. Medicina (Kaunas). 2021 Jun 3;57(6):573. doi: 10.3390/medicina57060573.
Results Reference
background
PubMed Identifier
34563506
Citation
Taha NA, Al-Khatib H. 4-Year Follow-up of Full Pulpotomy in Symptomatic Mature Permanent Teeth with Carious Pulp Exposure Using a Stainproof Calcium Silicate-based Material. J Endod. 2022 Jan;48(1):87-95. doi: 10.1016/j.joen.2021.09.008. Epub 2021 Sep 24.
Results Reference
background
PubMed Identifier
34854987
Citation
Asgary S, Eghbal MJ, Shahravan A, Saberi E, Baghban AA, Parhizkar A. Outcomes of root canal therapy or full pulpotomy using two endodontic biomaterials in mature permanent teeth: a randomized controlled trial. Clin Oral Investig. 2022 Mar;26(3):3287-3297. doi: 10.1007/s00784-021-04310-y. Epub 2021 Dec 2.
Results Reference
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Assessment of Pain and Treatment Success After VPT Versus RCT in Mature Permanent Mandibular Molars With SIP: A RCT
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