Novel Dental Cements (ALBO-MPCA) in Patients With Caries

NCT07507136 | Completed

• 1 other identifier: ALMBIH CT ID 08-07.5-1753-1/23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Cements on the base of the calcium silicates, like Mineral trioxide aggregate (MTA), and our cement mixture ALBO MPCA, as the object of this clinical trial, have various clinical applications. In the field of dentistry, they can be used in many ways during endodontic treatment procedures of both primary and permanent teeth. The high prevalence and recurrent nature of dental caries and periodontal disease demand endodontic treatment procedures. According to the World Health Organization (WHO), the Global Burden of Disease Study 2017 reported that untreated dental caries in permanent teeth is the most common health condition among the population. It has also been reported that 2.3 billion adults suffer from dental caries of permanent teeth, and over 530 million children suffer from dental caries of primary teeth (milk teeth) across the globe. Thus, the growing prevalence of tooth decay and gum diseases is likely to favor the growth of the market during the next period. The overall prevalence of caries increases with age, and the incidence rises steeply in adults older than 30-40 years. Such a burden of caries will continue to increase with the growing ageing population. The Global Burden of Disease Study in 2016 estimated that oral diseases affected half of the world's population (3.58 billion people), with dental caries in permanent teeth being the most prevalent condition assessed, while in children aged this number accounts for about 486 million. Early identification of children who are at high risk for dental caries indicates the need for a Caries-Risk Assessment (CRA) tool. Early CRA literature confirms the value of the identification of caries as a reliable way to predict future caries. On the basis of World Health Organization (WHO) data for decayed, missing, and filled teeth (DMFT), dental decay is the most prevalent chronic disease, and it is correlated to the consumption of carbohydrates and enamel demineralization due to microorganisms. More than 90% of people suffer from this disease. WHO reported that 60% to 90% of schoolchildren all around the world suffer from dental decay, and it is more prevalent in Asian countries and Latin America. In some reports in Bosnia and Herzegovina, almost all of the examined children had caries. The DMFT index shows that the number of diseased teeth is more than 4, even in the teenage years. In Serbia, only 8.5% of the population has all healthy teeth, while 9.3% of the population is toothless. Total income related to the caries healing is about 100 Euros per inhabitant, assuming that dental health control is regular, and if only one intervention on the teeth is made during one year. This is an enormous amount of money, showing the huge economic importance of the topic. Economical estimation for Bosnia and Hercegovina show income order of several tens of millions KM, therefore, successful treatment of caries has huge importance from the financial aspect also. In Serbia is a similar situation. The application of the ALBO-MPCA in various endodontic indications is considered the essential method for significant improvement of oral health for patients with advanced periodontitis. Following the main requirements for an ideal dental cement, such as its fast setting, pretty high compressive strength, satisfactory chemistry, antimicrobial properties, and particularly high biocompatibility and non-toxicity ALBO-MPCA shows the significant advantages compared with recently used dental calcium silicate cements, particularly expressed in its extraordinary high depth of the reparative dentin bridge, approved in a wide scale of animal assays. Therefore, it will be applied in clinical trials, for the healing of the tooth canal, direct pulp capping, and other endodontic applications, typical for such kinds of medical devices. Financial support of the study is provided by the sponsor's consortium, with ALBOS as the sponsor. The recruitment site is the House Health, Foča in the Republic of Srpska, Bosnia and Herzegovina.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (2)

• Safety evaluation during direct or indirect pulp capping and filling of the tooth roots, focusing on the tooth's pulp vitality, percussion, swelling, pain, and visual teeth changes

  Monitoring and reporting SAE and AE

  6 months

• Depth of reparative dentin after medical device application, and formation of a thick dentin bridge, determined by CBCT and explained in mm

  The reparative dentin depth, considered as the difference of dentine before and after 6 months from implantation of the medical device, determined by CBCT, is considered the main measure of direct or indirect pulp capping efficiency. As a valuable criterion of efficiency of a medical device, the reparative dentine depth close 150 µm is chosen.

  6 months

Secondary Outcomes (4)

• Calcification of pulpal stone, after direct or indirect pulp capping, determined by CBCT and explained in mm

  6 months

• Pulpal volume determination, after direct or indirect pulp capping, determined by CBCT and explained in mm

  6 months

• Tooth pain

  3 months

• Swelling or flare-up

  3 months

Study Arms (1)

ALBO MPCA group

EXPERIMENTAL

Device: ALBO MPCA

Interventions

ALBO MPCA DEVICE

ALBO MPCA represents the composite material, which consists of the active calcium silicate phase as a binder of this product, fillers that are constituted from calcium carbonate or/and/or hydroxyapatite, and gypsum, and a radiopaque phase consisting of barium sulphate or/and /or zirconium dioxide. The product has very good mechanical properties, extraordinary fast setting, excellent contrast, selling ability, and bioactivity. Due to its excellent biological properties, it is very promising as a material with high capacity for forming new dentine bridges with high thickness, which is crucial for clinical application in direct and indirect pulp capping.

ALBO MPCA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent has been signed
• Age 18 years and above
• Carious teeth that had no previous treatment
• Pulpal diagnosis of normal, healthy pulp
• Symptomless, curiously exposed vital teeth
• No clinical symptoms or evidence of pulp degeneration, such as history of spontaneous pain and tenderness to percussion, history of swelling or sinus tracts, pathologic mobility
• Teeth are restorable
• No radiographic evidence of pulp degeneration, such as internal or external resorption, inter-radicular, and/or periapical bone destruction, or pulp stones
• No clinical evidence of pulp degeneration, such as excessive bleeding from the pulp

You may not qualify if:

• Pregnancy and lactation 6 months before the study and during the study
• Significant renal or hepatic impairment
• Subject with a life expectancy of less than 6 months
• Subjects with unacceptable occlusal interferences oral hygiene, and non-compliant patients
• History of irreversible pulpal pain
• Immature teeth
• Non-restorable teeth
• Teeth with active periodontal disease
• History of any systemic disease
• Concurrent medication with systemic steroids, antibiotics, analgetics, immunomodulatory drugs, or cytostatics
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
• Participation in another research trial involving an investigational product in the past 12 weeks

Sponsors & Collaborators

• Albos d.o.o. Beograd: lead

Study Sites (1)

Health House Foča

Foča, Bosnia and Herzegovina

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 2, 2026
• Study Start: April 3, 2023
• Primary Completion: April 3, 2024
• Study Completion: February 26, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)