The Role of Matrix Metalloproteinases on the Primary Teeth Pulpotomy Treatments

NCT05145686 | Completed Phase 1 DMC

• 1 other identifier: Ege U.Eth. Com.16-7/14
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Matrix metalloproteinases (MMPs) are important zinc enzyme group that responsible for reducing extracellular matrix components. It has been reported that MMPs play an important role in pulpal inflammation. The aims of this in vivo study was to compare the expression levels of MMP-2, -8 and -9 in primary molars with reversible and irreversible pulpitis and to compare the clinically and radiographically success of MTA and Biodentine materials at the end of 18 months.

Conditions

Reversible Pulpitis

Keywords

MTA; Biodentine; Pulpotomy; Matrix metalloproteinase

Outcome Measures

Primary Outcomes (2)

• The role of MMP-2, 8 and 9 in reversible and irreversible pulpitis

  The expression levels of MMP-2, 8 and 9 were detected

  18 months

• Comparison of the clinical and radiographic success of MTA and Biodentine in primary teeth pulpotomy treatment

  MTA and Biodentine materials were used in primary molars with reversible pulpitis. At the end of 6, 12 and 18 months, all teeth were evaluated clinically and radiographically based on AAPD criteria: (1) absence of spontaneous pain and/or sensitivity to pressure; (2) absence of sinus, fistula, edema, and/or abnormal mobility; (3) absence of radiolucency at the interradicular and/or periapical regions; (4) absence of internal or external root resorption.

  18 months

Study Arms (2)

Comparing MMP-2, -8, -9 in reversible and irreversible pulpitis

EXPERIMENTAL

The coronal pulp samples from both reversible and irreversible groups were placed in an eppendorf tube containing TriPure Reagent transport medium. The MMP-2, -8 and -9 expression levels were determined with specific primers by real time polymerase chain reaction method (RT-PCR).

Diagnostic Test: Matris metalloproteinase -2, -8, -9 expressions

Comparing the clinical success of MTA and Biodientine in primary molar pulpotomy treatments

ACTIVE COMPARATOR

In reversible pulpitis group MTA (ProRoot MTA,white) was used in 21 teeth and Biodentine was used in the other 21 teeth for pulpotomy treatments. Final restorations were performed with stainless steel crowns in both group. At the end of 3, 6 and 9 months, all teeth were evaluated clinically and radiographically based on AAPD criteria: (1) absence of spontaneous pain and/or sensitivity to pressure; (2) absence of sinus, fistula, edema, and/or abnormal mobility; (3) absence of radiolucency at the interradicular and/or periapical regions; (4) absence of internal or external root resorption.

Diagnostic Test: Matris metalloproteinase -2, -8, -9 expressions

Interventions

Matris metalloproteinase -2, -8, -9 expressions DIAGNOSTIC_TEST

. The aims of this in vivo study was to compare the expression levels of MMP-2, -8 and -9 in primary molars with reversible and irreversible pulpitis and to compare the clinically and radiographically success of MTA and Biodentine materials at the end of 18 months.

Also known as: MTA and Biodentine

Comparing MMP-2, -8, -9 in reversible and irreversible pulpitis; Comparing the clinical success of MTA and Biodientine in primary molar pulpotomy treatments

Eligibility Criteria

• Age: 5 Years - 10 Years
• Gender Eligibility Details: 50% boy, 50% girl
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Cooperative pediatric patients aged 5-10 years,
• Deep carious lesion in mandibular primary second molars,
• The subjects did not receive any antiinflammatory medication 3 months prior to the study,
• Feasible restorative treatment,
• Positive parental informed consent.

You may not qualify if:

• Uncooperative children,
• Children with medically compromised disease,
• Presence of pathological root resorption and/or bone defect,
• Physiological root resorption more than one-third of the root,
• Unrestorable teeth,
• Negative parental informed consent.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, 35040, Turkey (Türkiye)

Location

Related Publications (1)

• Gerihan HE, Cogulu D, Oncag O, Durmaz A, Kuru EH. Assessment of MMP levels in reversible and irreversible pulpitis and a randomized controlled trial comparing clinical success of two different calcium-silicate cements in pulpotomy treatment of primary molars with an 18-month follow-up. BMC Oral Health. 2024 Aug 30;24(1):1020. doi: 10.1186/s12903-024-04795-5.

  PMID: 39215293 DERIVED

Study Officials

• Dilşah Çoğulu, Prof. Dr.

  Ege University, Izmir, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: observers were blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Experimental: Biodentine Dental materials Interventions: Drug: Biodentine Drug: ProRoot (Aggregate) Experimental: ProRoot MTA Dental Materials Interventions: Drug: Biodentine Drug: ProRoot (Aggregate)

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 6, 2021
• Study Start: January 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)