Comparative Evaluation of the Clinical Outcome of Direct Pulp Capping Treatment in Permanent Molars

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-40
SponsorKafrelsheikh University

About this trial

This clinical trial will be performed during June 2024 and December 2024. The study is conducted following the Declaration of Helsinki Ethical principles for medical research involving human subjects after being independently reviewed and approved by the Institution's Ethical Committee and is designed in accordance with CONSORT 2010.

Selected patients who are between 19 and 40 years of age had undergone conservative treatment for deep caries management in their permanent teeth in the restorative and endodontic departments, faculty of dentistry, Kafrelsheikh university. The patients are then assigned randomly into four different groups for this randomized clinical study. The decision for direct pulp capping will be made after informing the patients about all the pulp capping procedures that are suggested. Furthermore, any possible complications, postoperative discomfort, or failure of the treatment will be discussed with the patient. All included patients signed a written informed consent before enrollment

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

In all patients, the pulp had been exposed because of caries removal. Data collection included clinical pulp capping respecting the following criteria.

Disqualifiers

Individuals who are 19 to 40 years old.

Permanent teeth that have not been repaired and have extensive caries on their occlusal and proximal surfaces, extending more than two-thirds of the dentin near the pulp.

Vital teeth; asymptomatic teeth (not sensitive to pressure, percussion, or palpation, and no spontaneous pain); sinus tract devoid of swelling and abscess; abnormal mobility absent; no history of spontaneous pain; mild, dull, and tolerable pain associated with eating and drinking cold drinks.

Ethyl chloride cold tests, gutta-percha heat testing, palpation, percussion, and the lack of radiological symptoms in periapical radiographs are used to assess the life of the teeth prior to treatment. After the stimulus is removed, pain from a pulp test that is triggered by either heat or cold should subside.

Trial design

Design model

Parallel

Treatments tested in this trial

  • vital pulp therapy

    Procedure/Surgery

    vital pulp therapy using two bioactive materials TheraCal and RetroMTA as direct pulp caping materials conventionally and test using Diode laser before application of these materials

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: RetroMTA Conventional groupActive comparator 1 intervention
Group B: TheraCal Conventional groupActive comparator 1 intervention
Group C: RetroMTA laser groupActive comparator 1 intervention
Group D: TheraCal laser groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

postoperative pain

The postoperative pain was assessed on the numeric rating scale (NRS-11) 1,3 and 6 months after intervention. The examiner asked the patient to quantify his/her maximum pain intensity within the last 24 hours on a scale of 0 to 10. The following anchors were used to describe the rating scale: 0 = no pain/pain-free and 10 = worst pain imaginable.

Time frame
(1, 3, and 6 months
2

Radiographic assessments

The digital periapical radiographs were captured using a paralleling technique with Rinn film holders to allow standardization. Each root was examined for the presence, absence, and change (increase/decrease) in size of any PA radiolucency. A PA lesion or PDL gap expansion was referred to as a PA radiolucency. Less than double the equal healthy PDL space of the neighboring healthy tooth was considered a widening of the PDL space. A PA lesion was identified as radiolucency connected to the root's radiographic apex, greater than double the PDL space's breadth

Time frame
(1, 3, and 6 months

Secondary outcomes

Other outcomes

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