Clinical trial NCT05279781: Outcome of Pulpotomy Versus Root Canal Therapy
Official title: Quality of Life, Satisfaction and Outcome After Full Pulpotomy Compared to Root Canal Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caries
Pulpitis - Irreversible
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 9
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups. One will receive root canal treatment t and the other will receive pulpotomy.
Primary purpose: TREATMENT

Brief summary: Root canal therapy (RCT) is indicated once the pulp is diagnosed with irreversible pulpitis. Despite favorable success rate reported for RCT in vital cases, it is time consuming, and might increases fracture susceptibility of teeth. With the advancement of materials and better understanding of pulpal healing, vital pulp therapy is practiced as an alternative treatment with high success rate. The aim of this study is to explore the outcome, quality of life and patient satisfaction after full pulpotomy compared to RCT.

Detailed description: Permanent molar teeth with carious pulp exposure and mature roots as evident on the preoperative periapical radiograph will be included in the study. The teeth will be randomly divided into 2 groups (n=30). The first group will be treated with Biodentine full pulpotomy and the second group will be endodontically treated. Based on a previously validated questionnaire. The quality of life and satisfaction of patients after pulpotomy treatment will be evaluated compared to those after endodontic treatment. Clinical and radiographic assessment of the treated teeth will be done 3, 6 and 12 months postoperatively. Pain level will be recorded preoperatively and 1, 2, 3, 5 and 7 days after treatment.

The questionnaire consists of five components:

1. Characteristics of the patient; including age, gender, socioeconomic status, smoking, oral hygiene practices, frequency of dental visits, and dental history.
2. Postoperative complications including postoperative pain, discomfort,or swelling.

   These symptoms will be evaluated after 1, 2, 3,5 and 7 days by contacting the patient on the phone and at follow up visits at 3, 6, and 12 months.
3. Quality of life instruments designed
4. Semantic scales designed to evaluate patient satisfaction with the treatment received.

Clinical and radiographic assessment of the treated teeth will be recorded. Success will be defined as clinically asymptomatic tooth with no sinus tract or swelling or periapical lesion.

Data will be analysed statistically using appropriate tests based on the distribution of the results.

Eligibility criteria: Inclusion Criteria:

* Medically fit patient
* mature permanent tooth with deep caries
* diagnosis of irreversible pulpits.
* tooth is restored with a direct restoration

Exclusion Criteria:

* immature teeth
* teeth were hemostasis cannot be achieved after pulpotomy
* necrotic teeth
* lack of response to cold test

Primary outcomes:
measure: Post operative pain level on numerical pain scale
timeFrame: 7 days
measure: Post operative pain level on visual analogue scale
timeFrame: 7 days
Secondary outcomes:
measure: Clinical success
timeFrame: 6, 12, 24, 48 months
measure: Radiographic success
timeFrame: 6, 12, 24, 48 months
Other outcomes:
measure: The quality of life questionnaire
timeFrame: 6,12, 24, 48 months
Locations:
city: Irbid
country: Jordan
facility: Jordan University of science and technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Nessrin Taha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taha NA, About I, Sedgley CM, Messer HH. Conservative Management of Mature Permanent Teeth with Carious Pulp Exposure. J Endod. 2020 Sep;46(9S):S33-S41. doi: 10.1016/j.joen.2020.06.025.