Back to resultsFull Pulpotomy Versus Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis
Primary Purpose
Pulpitis - Irreversible
Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Root canal treatment (Control)
Full pulpotomy (Experimental)
Sponsored by
About this trial
This is an interventional treatment trial for Pulpitis - Irreversible
Eligibility Criteria
Inclusion Criteria: Patients aged 12 years or older (with a mature permanent tooth demonstrating radiographic evidence of a deep caries/restorations and signs/ symptoms indicative of IRP (moderate to severe spontaneous lingering pain). Tooth will be responsive to cold and EPT sensibility testing, restorable and can be adequately isolated during treatment. One posterior tooth (molar or premolar) only per patient. Exclusion Criteria: Teeth with active periodontal disease (pocket depth >5mm); teeth indicated for elective root canal treatment for restorative purposes, teeth with apical periodontitis, patients with complex medical histories that may affect their caries experience and healing ability (immunocompromised, radiotherapy), patients who are unable to consent; history of previous trauma to the tooth, presence of apical radiolucency and patients who are pregnant or breast-feeding. Intraoperatively, any evidence of purulence or excessive bleeding that cannot be controlled with a cotton pellet with 2-4% hypochlorite for 10 minutes will be excluded.
Sites / Locations
- Hany Mohamed Aly AhmedRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Root canal treatment (Control)
Full pulpotomy
Arm Description
The procedure can be carried out in single or two visits. Variations in root canal treatment protocols however will make it difficult to compare with pulpotomy so the aim is to standardize the protocols for the following variables including use of rubber dam, Irrigation protocol with 2-2.5% sodium hypochlorite; working length with combined radiographs and apex locators, automated instrumentation to accompany hand instrumentation and preparation to apical size 2-3 larger than the initial binding file. Canal to be medicated with non-setting calcium hydroxide if done in two visits and root canal filling with gutta percha and traditional sealers (warm or cold lateral condensation) and good coronal seal.
The clinical procedure will be completed over one or two visits. Following adequate anesthesia and isolation with rubber dam, access to the pulp will be gained following caries removal to de-roof the pulp chamber and excision of the entire coronal pulp. The pulp chamber is irrigated with 2% sodium hypochlorite solution and the resultant bleeding from the remaining pulp will be controlled with a cotton pellet soaked in 2% sodium hypochlorite solution. Following complete haemostasis, the pulp stump will then be covered with Biodentine (Septodont Ltd., Saint Maur des Fausse ́s, France) and the tooth permanently restored with a restoration if treatment is completed in single visit or temporized with glass ionomer cement for the final restoration to be placed in the 2nd visit if operator opted for 2-visit treatment.
Outcomes
Primary Outcome Measures
Clinical Data
(1) Clinical data: absence of pain, tenderness to palpation, presence of swelling, presence of sinus tract, pathological mobility, response to sensibility testing. Patient history taking and clinical examination for symptoms and clinical signs of infection such as swelling, and sinus tract will be performed by a blinded dental practitioner.
Radiographic data
(2) Radiographic data: presence of periapical radiolucency, presence of inter-radicular radiolucency, presence of resorption, presence of calcifications. An independent assessor will assess the radiograph obtained at the 12-month review visit.
Secondary Outcome Measures
Post-operative pain
(1) Postoperative pain will be recorded by patients on day 3 and 7. Pain will be assessed using a numeric rating scale (NRS). NRS is an 11-point numeric scale with 0 representing "no pain" and 10 representing "pain as bad as you can imagine". Patients will be instructed on how to use the NRS-11 at home on days 3 and 7 after the procedure. Patients will be contacted by phone call or text message to collect their responses.
Structural integrity assessment
(2) Structural integrity of the tooth will be assessed by a blinded dental practitioner at the 12-month visit using World Dental Federation (FDI) criteria
Evidence of further interventions and adverse effects
Evidence of further interventions and adverse events will be obtained from patient records following the 12-month review visit.
Data for cost effective analysis
Data for cost effective analysis and process evaluation will be collected.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06002698
Brief Title
Full Pulpotomy Versus Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis
Official Title
Full Pulpotomy Versus Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis: A Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Background The European Society of Endodontology (ESE) and the American Association of Endodontists (AAE) position statements on the management of deep caries and exposed pulp recommended adoption and promotion of strategies aimed at preserving the pulp, but also acknowledged the need for well-designed and adequately powered randomised control trials to provide the evidence needed to support vital pulp treatment (VPT) and change clinical practice.
Objectives
To undertake a randomised controlled clinical trial comparing full pulpotomy with root canal treatment for mature maxillary and mandibular posterior teeth with signs and symptoms indicative of irreversible pulpitis and normal apical tissues in adults.
Undertake a cost-effectiveness analysis to examine the potential long-term costs and benefits of pulpotomy.
Undertake a process evaluation to assess the acceptability of the intervention to both dentists and patients, while exploring the barriers and enablers to implementation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis - Irreversible
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Root canal treatment (Control)
Arm Type
Other
Arm Description
The procedure can be carried out in single or two visits. Variations in root canal treatment protocols however will make it difficult to compare with pulpotomy so the aim is to standardize the protocols for the following variables including use of rubber dam, Irrigation protocol with 2-2.5% sodium hypochlorite; working length with combined radiographs and apex locators, automated instrumentation to accompany hand instrumentation and preparation to apical size 2-3 larger than the initial binding file. Canal to be medicated with non-setting calcium hydroxide if done in two visits and root canal filling with gutta percha and traditional sealers (warm or cold lateral condensation) and good coronal seal.
Arm Title
Full pulpotomy
Arm Type
Experimental
Arm Description
The clinical procedure will be completed over one or two visits. Following adequate anesthesia and isolation with rubber dam, access to the pulp will be gained following caries removal to de-roof the pulp chamber and excision of the entire coronal pulp. The pulp chamber is irrigated with 2% sodium hypochlorite solution and the resultant bleeding from the remaining pulp will be controlled with a cotton pellet soaked in 2% sodium hypochlorite solution. Following complete haemostasis, the pulp stump will then be covered with Biodentine (Septodont Ltd., Saint Maur des Fausse ́s, France) and the tooth permanently restored with a restoration if treatment is completed in single visit or temporized with glass ionomer cement for the final restoration to be placed in the 2nd visit if operator opted for 2-visit treatment.
Intervention Type
Procedure
Intervention Name(s)
Root canal treatment (Control)
Intervention Description
Root canal treatment - Removal of the inflamed pulp tissues from the whole root canals of the tooth.
Intervention Type
Procedure
Intervention Name(s)
Full pulpotomy (Experimental)
Intervention Description
Full pulpotomy - Removal of the inflamed coronal pulp tissues from the crown of the tooth.
Primary Outcome Measure Information:
Title
Clinical Data
Description
(1) Clinical data: absence of pain, tenderness to palpation, presence of swelling, presence of sinus tract, pathological mobility, response to sensibility testing. Patient history taking and clinical examination for symptoms and clinical signs of infection such as swelling, and sinus tract will be performed by a blinded dental practitioner.
Time Frame
6 months, 1 year and 2 years
Title
Radiographic data
Description
(2) Radiographic data: presence of periapical radiolucency, presence of inter-radicular radiolucency, presence of resorption, presence of calcifications. An independent assessor will assess the radiograph obtained at the 12-month review visit.
Time Frame
6 months, 1 year and 2 years
Secondary Outcome Measure Information:
Title
Post-operative pain
Description
(1) Postoperative pain will be recorded by patients on day 3 and 7. Pain will be assessed using a numeric rating scale (NRS). NRS is an 11-point numeric scale with 0 representing "no pain" and 10 representing "pain as bad as you can imagine". Patients will be instructed on how to use the NRS-11 at home on days 3 and 7 after the procedure. Patients will be contacted by phone call or text message to collect their responses.
Time Frame
Day 3 and Day 7
Title
Structural integrity assessment
Description
(2) Structural integrity of the tooth will be assessed by a blinded dental practitioner at the 12-month visit using World Dental Federation (FDI) criteria
Time Frame
6 months, 1 year and 2 years
Title
Evidence of further interventions and adverse effects
Description
Evidence of further interventions and adverse events will be obtained from patient records following the 12-month review visit.
Time Frame
6 months, 1 year and 2 years
Title
Data for cost effective analysis
Description
Data for cost effective analysis and process evaluation will be collected.
Time Frame
Baseline, 6 months, 1 year and 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients aged 12 years or older (with a mature permanent tooth demonstrating radiographic evidence of a deep caries/restorations and signs/ symptoms indicative of IRP (moderate to severe spontaneous lingering pain). Tooth will be responsive to cold and EPT sensibility testing, restorable and can be adequately isolated during treatment. One posterior tooth (molar or premolar) only per patient.
Exclusion Criteria:
Teeth with active periodontal disease (pocket depth >5mm); teeth indicated for elective root canal treatment for restorative purposes, teeth with apical periodontitis, patients with complex medical histories that may affect their caries experience and healing ability (immunocompromised, radiotherapy), patients who are unable to consent; history of previous trauma to the tooth, presence of apical radiolucency and patients who are pregnant or breast-feeding. Intraoperatively, any evidence of purulence or excessive bleeding that cannot be controlled with a cotton pellet with 2-4% hypochlorite for 10 minutes will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hany Ahmed, PhD
Phone
0060129857937
Email
hanyendodontist@um.edu.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hany Ahmed, PhD
Organizational Affiliation
University Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hany Mohamed Aly Ahmed
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany MA Ahmed
Phone
0060129857937
Email
hanyendodontist@um.edu.my
First Name & Middle Initial & Last Name & Degree
Foo K Room
First Name & Middle Initial & Last Name & Degree
Nora Sakina M Noor
First Name & Middle Initial & Last Name & Degree
Noor Hayati Azami
First Name & Middle Initial & Last Name & Degree
Hany MA Ahmed
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share the IPD.
Citations:
PubMed Identifier
30664240
Citation
European Society of Endodontology (ESE) developed by:; Duncan HF, Galler KM, Tomson PL, Simon S, El-Karim I, Kundzina R, Krastl G, Dammaschke T, Fransson H, Markvart M, Zehnder M, Bjorndal L. European Society of Endodontology position statement: Management of deep caries and the exposed pulp. Int Endod J. 2019 Jul;52(7):923-934. doi: 10.1111/iej.13080.
Results Reference
background
PubMed Identifier
34352305
Citation
AAE Position Statement on Vital Pulp Therapy. J Endod. 2021 Sep;47(9):1340-1344. doi: 10.1016/j.joen.2021.07.015. Epub 2021 Aug 3. No abstract available.
Results Reference
background
PubMed Identifier
37080387
Citation
Taha NA, Abuzaid AM, Khader YS. A Randomized Controlled Clinical Trial of Pulpotomy versus Root Canal Therapy in Mature Teeth with Irreversible Pulpitis: Outcome, Quality of Life, and Patients' Satisfaction. J Endod. 2023 Jun;49(6):624-631.e2. doi: 10.1016/j.joen.2023.04.001. Epub 2023 Apr 19.
Results Reference
background
Learn more about this trial
Full Pulpotomy Versus Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis
We'll reach out to this number within 24 hrs