Efficacy Of Proinflammatory Cytokines in The Primary Molar Pulpotomy

NCT06398327 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/345
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

One of the main goals of pediatric dentistry is to preserve the functions and structures of primary teeth until the time of exfoliation. Especially carious lesions are the main factor in the early loss of primary teeth. Today, primary teeth can be kept in the mouth by applying different treatments depending on the degree of inflammation caused by carious lesions in the pulp tissue.Coronal pulpotomy application in asymptomatic primary teeth with deep carious lesions near the pulp is one of the most common methods to achieve the goal of retaining the tooth in place. The purpose of the pulpotomy technique is to remove the affected pulp tissue and maintain the normal function of the unaffected root pulp tissue until the tooth is naturally ready to exfoliate. Studies have shown that the degree of pulp inflammation and the materials used are effective in the success of this treatment. In studies evaluating pulpal inflammation, many biomarkers have been shown to play significant roles at different levels of inflammation. Recently, Presepsin has been studied as a biomarker for detecting bacterial infections. However, there is no study in the literature on the use of Presepsin as a biomarker in endodontic treatments. In our study, it is thought that Presepsin biomarker could be detected in cases of acute or chronic infection in pulp tissue and could be considered as one of the mediators of pulpal inflammation. Based on this, the aim of our study is to investigate whether the materials used in covering the pulp or the level of inflammation in the remaining pulp tissue is more important for the success of pulpotomy treatment. The inflammation level in the remaining pulp tissue will be measured using IL-6, IL-8, and Presepsin. Then, the one-year success of treatment in different groups where pulp tissue is randomly covered with MTA, NeoMTA, Biodentine, and Zinc oxide eugenol will be demonstrated. Thus, it will be evaluated whether materials previously found to be quite successful in other studies achieve success in pulps with high inflammation levels.

Conditions

Pulp Disease, Dental

Keywords

Presepsin; MTA; Neo MTA; Biodentine; zinc oxide eugenol; ıl-6; IL-8; Pulpal inflammation; Pulpotomy treatment; Primary molar teeth

Outcome Measures

Primary Outcomes (5)

• Clinical Success After Pulpotomy Treatment

  No signs of abscess or any swelling related to the tooth, no signs of fistula or other pathology, no signs of pathologic mobility, no post-operative pain, no pain on palpation or percussion of the tooth.

  6 Month - 1 Year

• Radiographic Success After Pulpotomy Treatment

  No signs of root resorption (internal or external), no signs of furcation involvement or periapical radiolucency, no signs of loss of lamina dura, presence of normal appearance of periodontal ligament space.

  6 Month - 1 Year

• IL-6 amount measurement using ELISA kit

  IL-6 levels were measured in ng/ml using the ELISA method. The measurement procedure was followed according to the manufacturer's instructions. The anti-IL-6 polyclonal antibody was pre-coated on 96-well plates. Blood samples and a biotin-conjugated antibody were added to the wells supplemented with Avidin-Biotin-Peroxidase Complex and 3,3',5,5'-tetramethylbenzidine in a mildly acidic buffer. A blue-colored product was produced and turned to yellow after an acidic stop solution was added. The intensity of the color yellow was proportional to the IL-6 amount bound on the plate. The optical density absorbance was measured spectrophotometrically at 450nm in a microplate reader and the concentration of IL-6 was calculated. For the expression of IL-6 concentrations in the samples, a standard curve was used.Optimal threshold values (cut-offs) for biomarkers were determined based on sensitivity and specificity, which were calculated from a ROC curve.

  6 Month - 1 Year

• IL-8 amount measurement using ELISA kit

  IL-8 levels were measured in ng/ml using the ELISA method. The measurement procedure was followed according to the manufacturer's instructions. The anti-IL-8 polyclonal antibody was pre-coated on 96-well plates. Blood samples and a biotin-conjugated antibody were added to the wells supplemented with Avidin-Biotin-Peroxidase Complex and 3,3',5,5'-tetramethylbenzidine in a mildly acidic buffer. A blue-colored product was produced and turned to yellow after an acidic stop solution was added. The intensity of the color yellow was proportional to the IL-8 amount bound on the plate. The optical density absorbance was measured spectrophotometrically at 450nm in a microplate reader and the concentration of IL-8 was calculated. For the expression of IL-8 concentrations in the samples, a standard curve was used.Optimal threshold values (cut-offs) for biomarkers were determined based on sensitivity and specificity, which were calculated from a ROC curve.

  6 Month - 1 Year

• Presepsin amount measurement using ELISA kit

  Presepsin levels were measured in ng/ml using the ELISA method. The measurement procedure was followed according to the manufacturer's instructions. The anti-Presepsin polyclonal antibody was pre-coated on 96-well plates. Blood samples and a biotin-conjugated antibody were added to the wells supplemented with Avidin-Biotin-Peroxidase Complex and 3,3',5,5'-tetramethylbenzidine in a mildly acidic buffer. A blue-colored product was produced and turned to yellow after an acidic stop solution was added. The intensity of the color yellow was proportional to the Presepsin amount bound on the plate. The optical density absorbance was measured spectrophotometrically at 450nm in a microplate reader and the concentration of Presepsin was calculated. For the expression of Presepsin concentrations in the samples, a standard curve was used.Optimal threshold values (cut-offs) for biomarkers were determined based on sensitivity and specificity, which were calculated from a ROC curve.

  6 Month - 1 Year

Secondary Outcomes (3)

• The Correlation Between Pre-Treatment Pain Presence and Radiographic Success After Pulpotomy Treatment

  1 Year

• The Correlation Between The Severity of Pulp Bleeding During Treatment and Radiographic Success After Pulpotomy Treatment

  1 Year

• The Correlation Between Pulp Bleeding Time During Treatment and Radiographic Success After Pulpotomy Treatment

  1 Year

Study Arms (4)

Zinc oxide eugenol cement

ACTIVE COMPARATOR

During pulpotomy treatment, a blood sample was taken from the coronal pulp and stored. The remaining pulp tissue was covered with ZOE, randomly selected from among four material groups. The teeth treated with ZOE were monitored for 12 months. Subsequently, the levels of IL-6, IL-8, and Presepsin in the blood were measured using the ELISA method and noted in ng/ml. Thus, the effect of the material used on the success of the treatment was determined based on the level of pulpal inflammation before treatment.

Procedure: PULPOTOMY TREATMENT

Mineral Trioxide Aggregate (MTA)

ACTIVE COMPARATOR

During pulpotomy treatment, a blood sample was taken from the coronal pulp and stored. The remaining pulp tissue was covered with MTA, randomly selected from among four material groups. The teeth treated with MTA were monitored for 12 months. Subsequently, the levels of IL-6, IL-8, and Presepsin in the blood were measured using the ELISA method and noted in ng/ml. Thus, the effect of the material used on the success of the treatment was determined based on the level of pulpal inflammation before treatment.

Procedure: PULPOTOMY TREATMENT

NeoMTA (newly developed mta)

ACTIVE COMPARATOR

During pulpotomy treatment, a blood sample was taken from the coronal pulp and stored. The remaining pulp tissue was covered with NeoMTA, randomly selected from among four material groups. The teeth treated with NeoMTA were monitored for 12 months. Subsequently, the levels of IL-6, IL-8, and Presepsin in the blood were measured using the ELISA method and noted in ng/ml. Thus, the effect of the material used on the success of the treatment was determined based on the level of pulpal inflammation before treatment.

Procedure: PULPOTOMY TREATMENT

Biodentine (biomaterial)

ACTIVE COMPARATOR

During pulpotomy treatment, a blood sample was taken from the coronal pulp and stored. The remaining pulp tissue was covered with Biodentine, randomly selected from among four material groups. The teeth treated with Biodentine were monitored for 12 months. Subsequently, the levels of IL-6, IL-8, and Presepsin in the blood were measured using the ELISA method and noted in ng/ml. Thus, the effect of the material used on the success of the treatment was determined based on the level of pulpal inflammation before treatment.

Procedure: PULPOTOMY TREATMENT

Interventions

PULPOTOMY TREATMENT PROCEDURE

During pulpotomy treatment, a bleeding sample was taken from the pulp and levels of presepsin, IL-6 and IL-8, which are important inflammation markers, were determined. During the treatment, MTA, Neo MTA, Biodentine and ZOE groups were randomly selected and the remaining pulp tissue was covered. After pulpotomy treatment, the teeth were followed for one year. Treatment success was evaluated according to the material used in teeth with high levels of inflammation at the beginning.

Biodentine (biomaterial); Mineral Trioxide Aggregate (MTA); NeoMTA (newly developed mta); Zinc oxide eugenol cement

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children between the ages of 6-9
• Children who do not have any systemic disease
• Primary second premolars in which physiological root resorption has not started.
• Cases where tooth decay at the interfaces exceeds ½ of the dentin thickness.
• Primary second premolars with provoked pain
• \. Lack of percussion sensitivity 5. Absence of radiolucent image in the periapical and furcal areas on x-ray 6. Clinical absence of abscess and fistula

You may not qualify if:

• Children with systemic diseases
• Having percussion sensitivity
• Radiolucent appearance in the periapical and furcal areas on x-ray
• Clinical presence of fistula
• Having night pain

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Faculty of Dentistry

Yakutiye, Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (28)

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MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• AYBİKE BAŞ

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant proffessor- pediatric dentistry

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: May 3, 2024
• Study Start: November 5, 2021
• Primary Completion: November 5, 2022
• Study Completion: May 17, 2023
• Last Updated: May 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)