Effectiveness of Pulpotomy in Symptomatic Permanent Teeth With Deep Caries Lesions
NCT ID: NCT06918639
Last Updated: 2025-04-09
Study Results
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Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2024-04-11
2027-01-01
Brief Summary
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In accordance with the above, the main objective of the study will be to determine the success of partial or total pulpotomy treatment in permanent teeth (\>18 adults) with a closed apex and symptoms compatible with irreversible pulpitis. At the same time, the association of factors related to the patient, the treated tooth and specific treatment factors with the success of pulpotomies will be determined. On the other hand, the patient, perception and satisfaction with the treatment received will be evaluated.
All treatments (pulpotomies and restorations) will be carried out by the principal investigator.
After recording the preoperative data, clinical and radiographic examination, a diagnosis will be made according to the classification of Wolters and collaborators , which will also guide us in the choice of pulp treatment: PP o CP Partial pulpotomy or complete pulpotomy. The maximum pulp haemostasis time will be 10 minutes. In both treatments, in the same appointment, the definitive restoration of the tooth will be carried out.
The evaluations will be performed at one week, 3 , 6 and 12 months postoperatively. This evaluation shall be performed by an examiner who shall be different from the one performing the treatment.
The main outcome of the present study will be the determination of the success of the pulpotomies.
\- Is vital pulp therapy a highly successful treatment for teeth with irreversible pulpitis?.
Outcome measure 1: Success rate of vital pulp therapy
\- Do patients feel satisfied with this conservative pulp treatment? Outcome measure 2: Patient´s satisfaction with vital pulp therapy
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Detailed Description
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After completion of the procedure, a patient survey will be given to the patient to record the patients, perception and satisfaction with the treatment received.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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to determinate the success of partial and total pulpotomy in permanent teeth
The main outcome of the present study will be the success rate of the treatment, determined by the absence of symptoms of irreversible pulpitis and the absence of radiological images compatible with pathology. The type of pulpotomy (partial or total) to be performed on each tooth will not be randomised for ethical reasons but, unlike other studies, will be determined clinically at the time of treatment according to the indication. Subsequently, the success of each treatment will be compared.
Pulpotomy
VPT: Partial pulpotomy: 2 mm of pulp tissue is removed with a high speed 014 diamond round bur different from the one used to remove carious tissue. In those cases in which access to the pulp tissue induces a painful sensation due to failure of the anaesthetic technique, intrapulpal anaesthesia shall be used, and this parameter shall be recorded.Cotton wool impregnated with 2.5% stabilised sodium hypochlorite shall be held over the pulp exposure to achieve haemostasis. If it is not possible to control bleeding, proceed to a complete pulpotomy procedure. If in this case it is impossible to achieve haemostasis, the possibility of performing a TPV is ruled out and the RCT is excluded from the study. Once haemostasis has been achieved, BiodentineXp is applied according to the manufacturer's instructions and a material thickness of 2-3 mm is ensured. Full pulpotomy: The same anterior procedure .Complete removal of the tissue from the pulp chamber. Maximum haemostasis time: 10 minutes
Interventions
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Pulpotomy
VPT: Partial pulpotomy: 2 mm of pulp tissue is removed with a high speed 014 diamond round bur different from the one used to remove carious tissue. In those cases in which access to the pulp tissue induces a painful sensation due to failure of the anaesthetic technique, intrapulpal anaesthesia shall be used, and this parameter shall be recorded.Cotton wool impregnated with 2.5% stabilised sodium hypochlorite shall be held over the pulp exposure to achieve haemostasis. If it is not possible to control bleeding, proceed to a complete pulpotomy procedure. If in this case it is impossible to achieve haemostasis, the possibility of performing a TPV is ruled out and the RCT is excluded from the study. Once haemostasis has been achieved, BiodentineXp is applied according to the manufacturer's instructions and a material thickness of 2-3 mm is ensured. Full pulpotomy: The same anterior procedure .Complete removal of the tissue from the pulp chamber. Maximum haemostasis time: 10 minutes
Eligibility Criteria
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Inclusion Criteria
* Patients in good general health, ASA I or ASA II with no contraindications to contraindications to receive a TPV procedure under local anaesthesia.
* Tooth with symptomatology of pulpitis, both reversible and irreversible, to be determined by history of spontaneous pain, exacerbation of pain with heat and cold confirmed by the cold test and radiating pain.
* Tooth without signs of pulp necrosis and absence of sinus tract and abscess.
* Tooth in occlusion with antagonist tooth and without discomfort on chewing.
* Tooth that can be directly restored.
* Tooth with pocket depth and mobility within normal limits.
* Extent of the caries lesion greater than two thirds of the amelodentine distance or which tooth or the pulp has been exposed during caries removal.
Exclusion Criteria
* Pregnant patients or patients who suspect pregnancy due to the impossibility of complementary radiographic tests cannot be carried out.
* Patients with systemic pathology that prevents the use of a vasoconstrictor or with a compromised immune system that may influence the response to treatment.
* Tooth with an immature apex.
* Tooth that is not restorable or not viable for preservation.
* Tooth with negative response to thermal sensitivity test or electrical test.
* Tooth in which haemostasis cannot be achieved after exposure of the pulp, or with a pulp, or with a haemostasis time exceeding 10 minutes, where there is no pulp bleeding or partial or complete tissue necrosis is observed.
18 Years
ALL
No
Sponsors
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Universidad Rey Juan Carlos
OTHER
Responsible Party
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OLGA GONZÁLEZ CASTRO
Student of the International Doctoral School, Universidad Rey Juan Carlos
Principal Investigators
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Laura Ceballos, Full Professor, DDS, PhD
Role: STUDY_DIRECTOR
Universidad Rey Juan Carlos
Victoria Fuentes, Associate Professor, DDS, PhD
Role: STUDY_DIRECTOR
Universidad Rey Juan Carlos
Locations
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Rey Juan Carlos University
Alcorcón, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Careddu R, Plotino G, Cotti E, Duncan HF. The management of deep carious lesions and the exposed pulp amongst members of two European endodontic societies: a questionnaire-based study. Int Endod J. 2021 Mar;54(3):366-376. doi: 10.1111/iej.13418. Epub 2020 Oct 19.
Wolters WJ, Duncan HF, Tomson PL, Karim IE, McKenna G, Dorri M, Stangvaltaite L, van der Sluis LWM. Minimally invasive endodontics: a new diagnostic system for assessing pulpitis and subsequent treatment needs. Int Endod J. 2017 Sep;50(9):825-829. doi: 10.1111/iej.12793. No abstract available.
Ramani A, Sangwan P, Tewari S, Duhan J, Mittal S, Kumar V. Comparative evaluation of complete and partial pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis: A randomized clinical trial. Int Endod J. 2022 May;55(5):430-440. doi: 10.1111/iej.13714. Epub 2022 Mar 10.
Jassal A, Nawal RR, Yadav S, Talwar S, Yadav S, Duncan HF. Outcome of partial and full pulpotomy in cariously exposed mature molars with symptoms indicative of irreversible pulpitis: A randomized controlled trial. Int Endod J. 2023 Mar;56(3):331-344. doi: 10.1111/iej.13872. Epub 2022 Dec 4.
Esteve-Pardo G, Barreiro-Gabeiras P, Esteve-Colomina L. Pulpectomy vs. Pulpotomy as Alternative Emergency Treatments for Symptomatic Irreversible Pulpitis-A Multicenter Comparative Randomised Clinical Trial on Patient Perceptions. Clin Pract. 2023 Aug 2;13(4):898-913. doi: 10.3390/clinpract13040082.
Hickel R, Mesinger S, Opdam N, Loomans B, Frankenberger R, Cadenaro M, Burgess J, Peschke A, Heintze SD, Kuhnisch J. Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting. Clin Oral Investig. 2023 Jun;27(6):2573-2592. doi: 10.1007/s00784-022-04814-1. Epub 2022 Dec 12.
Taha NA, Abdelkhader SZ. Outcome of full pulpotomy using Biodentine in adult patients with symptoms indicative of irreversible pulpitis. Int Endod J. 2018 Aug;51(8):819-828. doi: 10.1111/iej.12903. Epub 2018 Feb 27.
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.
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.
Ricucci D, Siqueira JF Jr, Li Y, Tay FR. Vital pulp therapy: histopathology and histobacteriology-based guidelines to treat teeth with deep caries and pulp exposure. J Dent. 2019 Jul;86:41-52. doi: 10.1016/j.jdent.2019.05.022. Epub 2019 May 21.
Smith AJ, Duncan HF, Diogenes A, Simon S, Cooper PR. Exploiting the Bioactive Properties of the Dentin-Pulp Complex in Regenerative Endodontics. J Endod. 2016 Jan;42(1):47-56. doi: 10.1016/j.joen.2015.10.019.
Other Identifiers
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100120240392024
Identifier Type: -
Identifier Source: org_study_id
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