Assessment of Pain and Treatment Success After VPT Versus RCT in Mature Permanent Mandibular Molars With SIP: A RCT

NCT ID: NCT05681494

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-26

Study Completion Date

2024-06-26

Brief Summary

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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

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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.

Conditions

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Symptomatic Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Root canal treatment

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.

Group Type ACTIVE_COMPARATOR

Root canal treatment

Intervention Type PROCEDURE

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.

Vital pulp therapy

exposed pulp will be capped with 3 mm calcium silicate material

Group Type EXPERIMENTAL

Vital pulp therapy

Intervention Type PROCEDURE

exposed pulp will be capped with 3 mm calcium silicate material

Interventions

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Root canal treatment

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

Vital pulp therapy

exposed pulp will be capped with 3 mm calcium silicate material

Intervention Type PROCEDURE

Other Intervention Names

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RCT, Full pulpectomy pulpotomy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Amany Ibrahiem Ahmed Mohamed

Ph.D. degree candidate, Department of Endodontics, Faculty of Dentistry, Cairo university.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed S Elsheshtawy

Role: STUDY_DIRECTOR

Lecturer, Department of Endodontics, Faculty of Dentistry, Cairo university.

Central Contacts

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Amany IA mohamed, phd

Role: CONTACT

01099300346 ext. 002

References

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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.

Reference Type BACKGROUND
PMID: 35152464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34205149 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34563506 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34854987 (View on PubMed)

Other Identifiers

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28/12/2022

Identifier Type: -

Identifier Source: org_study_id

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