Post-Operative Pain After Vital Pulpotomy in Molars With Symptomatic Pulpitis

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

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-15

Study Completion Date

2024-03-15

Brief Summary

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The goal of this clinical trial is to investigate post-operative pain (PEP) in teeth with symptomatic pulpitis following Vital Pulpotomy Treatments (VPT) with Calcium Silicate Cement (CSC). The main questions it aims to answer are:

* Is the post-operative pain one week after VPT significantly lower than pre-operative pain in permanent molars with symptomatic pulpitis?
* How does post-operative pain in these teeth correlate with patient-related factors, such as age, gender, and painkiller intake?

Participants will:

* Undergo Vital Pulpotomy Treatment with Calcium Silicate Cement (MTA)
* Provide pain level assessments before VPT, immediately post-treatment, and at 24, 72 hours, and 1 week after treatment.

If there is a comparison group:

Researchers will compare the post-operative pain levels in teeth with symptomatic pulpitis undergoing VPT to assess its effectiveness in reducing pain compared to a control group not undergoing the treatment.

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Detailed Description

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Informed Consent:

Volunteers or parents will receive detailed information about protocols, risks, and benefits. Informed consent was obtained in writing after providing subject information, and participants could withdraw voluntarily at any time.

Sample Size Calculation:

Sample size calculation, utilizing G. Power-3.1.9.2, aimed at relationship analyses with a 95% confidence level, α=0.05, effect size of 0.30, and theoretical power of 0.80, resulting in a minimum sample size of 108.

Treatment Procedure:

Vital pulpotomy, administered by experienced professionals, involved local anesthesia, rubber dam isolation, caries removal, pulp amputation, hemostasis, application of ProRoot MTA and glass ionomer, and permanent restoration. Pain scores, assessed using the modified Wong-Baker scale, were recorded pre-treatment, at 24 and 72 hours post-procedure, along with inquiries about painkiller usage.

Conditions

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Pulpitis Post Operative Pain Toothache

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with symptomatic pulpitis

vital permanent molars with symptomatic pulpitis in patients aged between 7-70

Vital Pulpotomy

Intervention Type PROCEDURE

Vital pulpotomy involves the removal of the coronal pulp, while MTA is used to seal the root orifices. It is clear that vital pulp treatments for symptomatic pulpitis are a more reliable, cost-effective, and generally easier option than root canal treatment (RCT) once the mineral trioxide aggregate (MTA) is introduced in dentistry. In vital pulpotomy, as opposed to RCT, tooth healing and symptoms are diminished while the vitality of the tooth is maintained. Furthermore, vital pulpotomy is a significantly more practical and economical treatment alternative than RCT.

Interventions

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Vital Pulpotomy

Vital pulpotomy involves the removal of the coronal pulp, while MTA is used to seal the root orifices. It is clear that vital pulp treatments for symptomatic pulpitis are a more reliable, cost-effective, and generally easier option than root canal treatment (RCT) once the mineral trioxide aggregate (MTA) is introduced in dentistry. In vital pulpotomy, as opposed to RCT, tooth healing and symptoms are diminished while the vitality of the tooth is maintained. Furthermore, vital pulpotomy is a significantly more practical and economical treatment alternative than RCT.

Intervention Type PROCEDURE

Other Intervention Names

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vital pulp amputation

Eligibility Criteria

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Inclusion Criteria

* Patients aged between 7 and 70 years
* The teeth with diagnosis of irreversible symptomatic pulpitis
* Permanent first and second molars with vital pulp
* PAI ≤ 2 with vital pulp. (Ørstavik D, Kerekes K, \& Eriksen HM (1986) The periapical index: A scoring system for radiographic assessment of apical periodontitis Dent Traumatol 2(1) 20-34, https://doi.org/10.1111/j.1600-9657.1986.tb00119.x.)

Exclusion Criteria

* Clinical or radiographic signs of a necrotic pulp
* The presence of a sinus, buccal tenderness, pathological mobility or evidence of pathology on a periapical radiograph
* Teeth with horizontal or vertical root fractures
* Swelling, acute endodontic, or periodontal abscess
* Insufficient tooth tissue for a restoration, teeth requiring a post
* Unable to give informed consent
* Contraindicated systemic disease
* Allergies the local anesthesia
* Antibiotics, biphosphonates, and corticosteroid intake during the 7 days before treatment.
* Pregnancy or breastfeeding.
* Patients who needed endodontic treatment on several teeth to avoid a potentially confused pain referral.

Minimum Eligible Age

7 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No