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

The First/Second Phase of an Open Clinical Trial of Calcium-based Silicate ALBO-MPCA in Patients by Using Method of Direct or Indirect Pulp Capping

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Device: ALBO MPCA

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bosnia and Herzegovina
  • Foča, Bosnia and Herzegovina
    • Health House Foča

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ALBO MPCA group

Device: ALBO MPCA; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calcification of pulpal stone, after direct or indirect pulp capping, determined by CBCT and explained in mm	Teeth with pulpal stone, e.g. teeth with calcified masses of mineralized tissue found within the dental pulp chamber or root canals should be divided into two group: first with teeth which contain dentine and second group which teeth do not have dentin. The presence dentine is 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	Pulpal volume determination assumes the quantifying od the three-dimensional space of the dental pulp chamber and canals, by micro-CT using software segmentation to measure pulp volume and tooth volume (PV/TV) ratios.	6 months
Tooth pain	Pulpal tooth pain test after 7 days and 3 months after direct and indirect pulp capping should be determined using the thermal test, by taping the teeth, to determine the vitality of the pulp (0 - no pain (healthy), 1 - pain (unhealthy)).	3 months
Swelling or flare-up	Swelling or flare-up 3 months after direct and indirect pulp capping, using a small, thin ruler with millimeter markings inserted gently between the teeth and gum line. Criteria of the health of gums and bone support is given by scale 1-5 mm, where 1-3 mm corresponds to healthy state, 4 mm indicate gingivitis or inflammation and 5 mm or more periodontal pockets.	3 months

Collaborators and Investigators

• Sponsor: Albos d.o.o. Beograd

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Actual): April 3, 2024
• Study Completion (Actual): February 26, 2026

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: ALMBIH CT ID 08-07.5-1753-1/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No