Clinical trial NCT06802549: Outcomes of Partial Pulpotomy Treatment in Cariously Exposed Teeth
Official title: Treatment Outcomes of Partial Pulpotomy Using Two Different Calcium Silicate Materials in Cariously Exposed Mature Permanent Teeth: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Deep Dental Caries
Keywords: deep dental caries
partial pulpotomy
calcium silicate-based material
Lead sponsor: Firat University
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trial is to learn how successful Biodentine and Theracal PT dental filling materials are in treating deep tooth decay in adults. It will also provide information about post-treatment pain. The main questions it aims to answer are:

Do Biodentine and Theracal PT dental filling materials treat exposed tooth decay in participants? Do they reduce the need for root canal treatment? After the application of Biodentine and Theracal PT dental filling materials to the participants, the pain and symptoms that cause pain may not decrease. In this case, the tooth may be treated with root canal treatment. The researchers will compare the clinical success of Biodentine and Theracal PT dental filling materials with each other.

Participants will undergo a single-session partial pulpotomy treatment with the dental filling materials mentioned above. Clinical and radiographic follow-ups will then be performed at 3, 6 and 12 months, and records will be kept.


Eligibility criteria: Inclusion Criteria:

* • Patient age should be between 18-50 years

  * Should be able to give written informed consent
  * Should have systemic status (ASA 1)
  * Should have permanent molar or premolar (lower and upper) root development
  * Should be asymptomatic, deep (D3) or extremely deep (D4) caries
  * Should give vital response in cold test and electric pulp test
  * Should have teeth where the pulp is exposed with caries
  * Should not have pain during palpation and percussion
  * Should not have periodontal disease
  * Should have restorable teeth
  * Should have teeth without pulp necrosis, sinus tract or swelling/abscess
  * Should have bleeding time less than 10 minutes
  * Should be able to include a maximum of two teeth in a patient in the study (should be in different quadrants and there should be at least 2 weeks between treatment periods)

Exclusion Criteria:

* Teeth with incomplete root development

  * Severely affected teeth that do not respond to pulp sensitivity tests
  * Teeth with signs and symptoms of irreversible pulpitis
  * Teeth without signs of bleeding after communicating with the pulp chamber
  * Teeth with pulp chamber open to the oral environment
  * Teeth with periodontal pockets greater than 4 mm deep
  * Teeth with suspected cracks or crown fractures that may be responsible for pulp pathology
  * Teeth with uncontrolled bleeding
  * Medically at-risk patients will be excluded from the study.

Primary outcomes:
measure: "Tooth survival". Both clinical and radiographic healing means "Tooth survival". Clinical healing; absence of clinical symptoms. Radiographic healing; absence of emerging periapical radiolucency.
timeFrame: From enrollment to the end of treatment at 1 year
Secondary outcomes:
measure: "Post operative pain". It will be evaluated with a 10-unit visual analog scale. 0: no pain, 1-3 mild pain, 4-6 moderate-severe pain, 7-9 very severe pain, 10 worst pain.
timeFrame: From enrollment to the follow up at 1 week, 3,6.12 months"
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Firat University
Study officials:
References:
citation: Duncan HF. Present status and future directions-Vital pulp treatment and pulp preservation strategies. Int Endod J. 2022 May;55 Suppl 3(Suppl 3):497-511. doi: 10.1111/iej.13688. Epub 2022 Feb 3.
citation: 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.
citation: European Society of Endodontology (ESE) developed by:; Duncan HF, Galler KM, Tomson PL, Simon S, El-Karim I, Kundzina R, Krastl G, Dammaschke T, Fransson H, Markvart M, Zehnder M, Bjorndal L. European Society of Endodontology position statement: Management of deep caries and the exposed pulp. Int Endod J. 2019 Jul;52(7):923-934. doi: 10.1111/iej.13080.