Clinical trial NCT06874062: Evaluation of Primary Tooth Pulpotomy With Resin Modified Calcium Silicate
Official title: Clinical and Radiographic Evaluation of the Success of Resin-Modified Calcium Silicate in Primary Tooth Pulpotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulpotomy
Keywords: pulpotomy
mineral trioxide aggregate
resin-modified calcium silicate cement
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 70
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate whether Theracal PT, a resin-modified calcium silicate-based material, can be successfully used in pulpotomy treatment for primary molar teeth. The efficacy of this material will be compared with MTA in its putty form (Neoputty) and powder-liquid form (ProRoot). The main questions this study aims to answer are: Is Theracal PT as effective as MTA, the gold standard for pulpotomy treatment? Is Neoputty MTA, which is easier to handle, more effective than ProRoot MTA? The study will include systemically healthy children aged 4 to 9 years with at least one primary molar requiring pulpotomy. Treated teeth will be evaluated clinically and radiographically at 3, 6, and 12 months.

Detailed description: Tooth decay is a complex process of enamel demineralization and remineralization caused by organic acids produced by microorganisms in the dental plaque. When this balance shifts in favor of demineralization, caries formation occurs. Initially, decay begins with small surface roughness or subsurface demineralization, followed by cavitation and subsequent pulp involvement.

Tooth decay, one of the most common chronic diseases in childhood, negatively impacts the quality of life when left untreated, leading to problems such as pain, abscess formation, tooth loss, nutritional deficiencies, and speech disorders. To prevent early loss of primary teeth and maintain the health of the oral and surrounding tissues, restorative or endodontic treatments are applied. Treatment methods for deep dentin caries in primary teeth include indirect pulp capping, direct pulp capping, and amputation, with amputation being the most commonly used vital pulp therapy. Amputation is indicated when the pulp is either healthy or reversibly damaged and shows no signs of pulp degeneration, and the pulp becomes exposed during caries removal due to decay or mechanical causes. The goal of treatment is to preserve the vitality of the radicular pulp, control pain and inflammation, and maintain the tooth until its physiological exfoliation time. The selection of appropriate materials and techniques for amputation therapy is of critical importance. Although several studies have investigated the success of amputation materials and techniques, the ideal amputation material has not yet been defined. The ideal material and technique should be bactericidal, harmless to the pulp and surrounding tissues, support the healing of the root pulp, and contribute to the preservation of remaining tissues without affecting physiological root resorption. Additionally, factors such as cost and ease of application should also be considered in material selection. Therefore, efforts to identify the ideal amputation material continue.

The aim of this study is to evaluate the clinical and radiographic success of Theracal PT®, ProRoot® MTA, and Neoputty® MTA, and to examine the relationship between these outcomes and factors such as age, gender, the position of the tooth in the arch, and the presence of provoked pain prior to treatment.

The following hypotheses were proposed in our study:

Hypothesis 1: There is no difference in the 12-month clinical and radiographic success rates of primary tooth amputation treatments performed using Neoputty® MTA, ProRoot® MTA, and Theracal PT®.

Hypothesis 2: The 12-month clinical and radiographic success of amputation treatments performed using Neoputty® MTA, ProRoot® MTA, and Theracal PT® is not influenced by age, gender, the position of the tooth in the arch, or the presence of provoked pain prior to treatment.

This study was conducted in accordance with the Ataturk University Faculty of Medicine Ethics Committee approval (Date: 30.03.2023/ Session no:02/ Decision no:04) and guidelines of the Helsinki Declaration. The study was supported by the Scientific Research Projects Coordination Unit of Atatürk University under project number TDH-2023-13045. In this study, the teeth to be treated were randomly assigned using stratified randomization, ensuring an equal number of teeth in each study group. The research design was based on a parallel groups model. When multiple teeth from the same patient participated in the study, randomization was also applied for the other materials to be used. Patient selection, examination, treatment, and follow-up processes were carried out by a single researcher undergoing specialty training in the Department of Pediatric Dentistry.

Eligibility criteria: Inclusion Criteria:

* Deep dentin caries,
* Lamina dura and periodontal interval can be observed normally,
* 2/3 of the root length is present,
* The permanent tooth germ below is present and its position is normal,
* If there is a history of provoked pain (the type of pain that goes away when the stimulus is removed),
* If there is a history of pain (short-term provoked pain, the pain goes away when the stimulus is removed,
* Teeth with mechanical perforation larger than a needle tip in the perforation area or perforated with caries,
* Teeth with light-colored bleeding and easily controlled within 3-5 minutes,
* Teeth that can be restored with PÇK were included in the study

Exclusion Criteria:

* Lesions in the inter-root and periapical region,
* Pathological external or internal root resorption,
* Canal calcification,
* Deformities such as taurodontism,
* Spontaneous pain or night pain,
* Structural anomalies,
* Abscess, swelling or fistula,
* Pathological mobility,
* Sensitivity to palpation and percussion,
* Infraocclusion,
* Dark, intense bleeding in the canal orifices

Primary outcomes:
measure: Clinical Success
timeFrame: 1 Month - 1 Year
measure: Radiographic Success
timeFrame: 3 Month - 1 Year
Secondary outcomes:
measure: The Impact of Patient's Age on 12-Month Radiographic Success of Treatment.
timeFrame: From treatment to the end of 12 months
measure: The Impact of Patient's Gender on 12-Month Radiographic Success of Treatment.
timeFrame: From treatment to the end of 12 months
measure: The Impact of Tooth Position in the Dental Arch on the 12-Month Radiographic Success of Treatment
timeFrame: From treatment to the end of 12 months
measure: The Impact of Pre-Treatment Provoked Pain on the 12-Month Radiographic Success of Treatment.
timeFrame: From treatment to the end of 12 months
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
affiliation: Ataturk University Faculty of Dentistry
name: Fatih Şengül, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cordell S, Kratunova E, Marion I, Alrayyes S, Alapati SB. A Randomized Controlled Trial Comparing the Success of Mineral Trioxide Aggregate and Ferric Sulfate as Pulpotomy Medicaments for Primary Molars. J Dent Child (Chic). 2021 May 15;88(2):120-128.
citation: Waterhouse P. Are different pulp treatment techniques and associated medicaments effective for the treatment of extensive decay in primary teeth? Evid Based Dent. 2021 Jan;22(1):12-13. doi: 10.1038/s41432-021-0162-6.
citation: Celik B, Atac AS, Cehreli ZC, Uysal S. A randomized trial of mineral trioxide aggregate cements in primary tooth pulpotomies. J Dent Child (Chic). 2013 Sep-Dec;80(3):126-32.
citation: Wassel M, Hamdy D, Elghazawy R. Evaluation of four vital pulp therapies for primary molars using a dual-cured tricalcium silicate (TheraCal PT): one-year results of a non-randomized clinical trial. J Clin Pediatr Dent. 2023 Mar;47(2):10-22. doi: 10.22514/jocpd.2023.004. Epub 2023 Mar 3.