The Effects of Fixed Space Maintainers Luting with Self-Adhesive Resin Cement on the Gingival Crevicular Fluid of Interleukin-18 Level

NCT06811597 | Completed Phase 4

• 1 other identifier: 2011-KAEK-2/ 2022/7336
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

Background:In pediatric dentistry, fixed space maintainers are crucial for preserving the space in edentulous areas following premature tooth loss and promoting the healthy development of the dental arch, maxilla, and mandibula. A vital aspect in ensuring the long-term functionality of the space maintainer is the selection of the appropriate luting agent. Conventional glass ionomer cements (GIC), known for their chemical properties and biocompatibility, are widely regarded as safe and effective luting agents. Despite the prevalent use of resin cements (RCs) in modern dentistry, studies examining the effects of fixed space maintainers (FSMs) luted with resin cements (RCs) on periodontal status are lacking. Material:This split-mouth design study involved 31 children aged 6 to 10 years who prematurely lost their mandibular second primary molars. The left mandibular first molars were bonded with FSM High-Q-Bond Band™ self-adhesive resin cement, while the right molars were bonded with Meron (conventional glass ionomer cement). Gingival Index (GI), Plaque Index (PI), and Periodontal Probing Depth (PPD) were measured before luting and at the 1-week follow-up. Gingival crevicular fluid (GCF) was collected from the abutment teeth using Periopaper® strips before luting and at the one-week follow-up. ELISA was then performed to measure the levels of the proinflammatory cytokine Interleukin-18(IL-18). Statistical Analyses involved the Mann-Whitney U test for comparing two groups of qualitative and quantitative variables, and the Wilcoxon Signed Ranks test for assessing differences between two dependent quantitative variables. A significance threshold of p \< 0.05 was used for statistical inference.

Conditions

Gingival and Periodontal Disease; Space Maintenance; Resin Cements; Interleukin

Keywords

Fixed Space Maintainer; IL-18; Resin Cement; Self Adhesive; Gingival Inflammation; Luting Cement

Outcome Measures

Primary Outcomes (1)

• IL-18

  We will examine IL-18 expression levels and changes in gingival crevicular fluid and gingival tissue samples related to gingivitis and periodontal diseases.

  1 week.

Secondary Outcomes (3)

• Plaque İndex

  1 week

• Gingival Index

  1 week

• Periodontal Probing Depth

  1 week

Study Arms (2)

Voco Meron Conventional Glass Ionomer Group

ACTIVE COMPARATOR

The right molars were bonded with conventional glass ionomer cement.

Procedure: Voco Meron Conventional Glass Ionomer

High-Q-Bond Band™ self-adhesive resin cement

EXPERIMENTAL

The left mandibular first molars were bonded with FSM High-Q-Bond Band™ self-adhesive resin cement.

Procedure: High-Q-Bond Band™ self-adhesive resin cement.

Interventions

Voco Meron Conventional Glass Ionomer PROCEDURE

The right molars were bonded with Meron

Voco Meron Conventional Glass Ionomer Group

High-Q-Bond Band™ self-adhesive resin cement. PROCEDURE

The left mandibular first molars were bonded with FSM High-Q-Bond Band™ self-adhesive resin cement.

High-Q-Bond Band™ self-adhesive resin cement

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children who have not received any antibiotic treatment in the past four months,
• Children who do not have any underlying systemic diseases.
• Children who are not required to take medication regularly,
• Both girls and boys between the ages of 6 and 10.
• The second primary molar teeth (75 and 85) were extracted from patients due to caries and associated periapical pathologies.
• The presence of the succeeding tooth germ.
• Pediatric patients exhibiting Angle Class I occlusal relationships.
• Children without skeletal abnormalities.
• Existence of the antagonistic tooth of the abutment tooth.
• Children and their parents willing to participate in the study and attend the control session one week later were included.

You may not qualify if:

• The patient presents with periodontal disease.
• Children with cognitive disabilities, including autism and attention deficit hyperactivity disorder, as well as those with mental health conditions such as cerebral palsy and Down syndrome.
• Children and their parents who did not meet the specified criteria were excluded from the study.

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (2)

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03300, Turkey (Türkiye)

Location

Afyonkarahisar Health Science

Afyonkarahisar, 03300, Turkey (Türkiye)

Location

Related Publications (26)

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MeSH Terms

Conditions

Periodontal Diseases; Gingivitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Study Officials

• Suat Serhan Altıntepe Doğan, Assoc. Prof. (PhD)

  Afyonkarahisar Health Sciences University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This split-mouth design study involved 31 children aged 6 to 10 years who prematurely lost their mandibular second primary molars. The left mandibular first molars were bonded with FSM High-Q-Bond Band™ self-adhesive resin cement, while the right molars were bonded with Meron (conventional glass ionomer cement). Gingival Index (GI), Plaque Index (PI), and Periodontal Probing Depth (PPD) were measured before luting and at the 1-week follow-up. Gingival crevicular fluid (GCF) was collected from the abutment teeth using Periopaper® strips before luting and at the one-week follow-up. ELISA was then performed to measure the levels of the proinflammatory cytokine Interleukin-18(IL-18).

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 6, 2025
• Study Start: June 13, 2022
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: February 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)