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Dental caries, highly prevalent amongst children, can cause pulpitis. Coronal pulpotomy provides an easier, cost-effective, conservative and biologically-driven treatment option compared to endodontic treatment in mature permanent teeth with irreversible pulpitis.
The aim of the current study is to evaluate postoperative pain, clinical and radiographic outcomes of MTA pulpotomy compared to root canal treatment in children's first permanent molars suffering from irreversible pulpitis.
In this randomized controlled trial, patients aged 10-14 years suffering from irreversible pulpitis in the first permanent molar with closed apex will be randomly divided into two groups. The first group will receive complete coronal MTA pulpotomy, while the second group will receive endodontic treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MTA Pulpotomy | Experimental | Local anesthesia for pain control will be administered, followed by rubber dam isolation. Then, the tooth and surrounding rubber dam will be flushed with chlorhexidine solution for disinfection. After caries removal, a sterile bur will be used for access opening and complete deroofing of the pulp chamber. Coronal pulp tissue will be removed to the level of canal orifices using a sterile, sharp spoon excavator. A cotton pellet dampened with sodium hypochlorite will be applied on canal orifices to achieve hemostasis. This will be followed by MTA application and glass ionomer restoration. If necessary, the tooth will be restored with stainless steel crown after one week. |
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| Root Canal Treatment | Active Comparator | Local anesthesia for pain control will be administered, followed by rubber dam isolation. Then, the tooth and surrounding rubber dam will be flushed with chlorhexidine solution for disinfection. After caries removal, a sterile bur will be used for access opening and complete deroofing of the pulp chamber. Length of the root canal will be obtained using an apex locator. This will be followed by mechanical shaping using files, and irrigation with 2.5 percent sodium hypochlorite, followed by drying of the canals using paper points. Obturation will then be accomplished using gutta percha and sealer. Finally, the tooth will be restored with conventional glass ionomer restoration. If necessary, the tooth will be restored with stainless steel crown after one week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MTA Pulpotomy | Procedure | Complete coronal MTA pulpotomy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief | A 10 cm visual analogue scale will be used to record pain | preoperatively, immediately postoperatively and every 24 hours for 7 days after the first appointment. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Evaluation |
| 3, 6, 12 and 18 months postoperatively |
| Radiographic Evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alaa A. Eissa, Msc | Contact | 00201012036000 | alaaeissa@dent.asu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Alaa A. Eissa, Msc | Faculty of Dentistry, Ain Shams University, Cairo, Egypt | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29061359 | Result | Galani M, Tewari S, Sangwan P, Mittal S, Kumar V, Duhan J. Comparative Evaluation of Postoperative Pain and Success Rate after Pulpotomy and Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial. J Endod. 2017 Dec;43(12):1953-1962. doi: 10.1016/j.joen.2017.08.007. Epub 2017 Oct 20. | |
| 37080387 |
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Data obtained through this study may be provided to qualified researchers. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement.
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| ID | Term |
|---|---|
| D004708 | Endodontics |
| ID | Term |
|---|---|
| D003813 | Dentistry |
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| Root Canal Treatment | Procedure | Conventional root canal treatment. |
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| 6, 12 and 18 months postoperatively |
| 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. |
| 34854987 | Result | 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. |
| 35160239 | Result | Beauquis J, Setbon HM, Dassargues C, Carsin P, Aryanpour S, Van Nieuwenhuysen JP, Leprince JG. Short-Term Pain Evolution and Treatment Success of Pulpotomy as Irreversible Pulpitis Permanent Treatment: A Non-Randomized Clinical Study. J Clin Med. 2022 Jan 31;11(3):787. doi: 10.3390/jcm11030787. |