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

January 31, 2025 updated by: Özgür Doğan, Afyonkarahisar Health Sciences University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction Fixed space maintainers (FSMs) are important preventive orthodontic devices used in pediatric dentistry. These devices are specifically designed to preserve the spaces left by premature tooth loss or planned tooth extractions. Maintaining these spaces is crucial for guiding the proper eruption of permanent teeth, contributing to a child's healthy dental development. Pediatric dentists are the most frequently consulted professionals during this stage, and their preventive practices significantly impact the preservation of the edentulous space during the transition from mixed dentition to permanent dentition.

The primary objective of all types of space maintainers in primary and mixed dentition is to preserve arch length by preventing space loss within the dental arch. Space loss may occur as a result of the mesial migration of teeth positioned distal to an edentulous area through tipping, or due to the distal drifting of teeth that remain mesial to the edentulous region. The type and design of space maintainers employed to preserve the edentulous spaces resulting from premature loss of primary teeth are contingent upon various factors. These factors include the number of teeth that have been lost in the affected area, the stage of the child's dental development, and the specific dental arch where the space maintainer is to be applied. Considering all these factors, FSMs are the most preferred option among the various types of space maintainers, as they remain unaffected by jaw or dental arch conditions.

Preventing malocclusions in a developing child due to the premature loss of primary teeth is crucial. This can be accomplished by using a space maintainer as soon as possible after a tooth extraction. This can protect the space left by the missing tooth and help maintain the proper arch length as the child continues to grow. FSMs need to remain cemented in the mouth for an extended period, as even a matter of days can be significant in this process. To achieve optimal results, the cementation process must be conducted with durable luting cement. Traditionally, it has been advised to cement FSMs using conventional glass ionomer cement (GIC). However, over the past decade, resin cement (RC) has become increasingly prevalent due to significant advancements in bonding technology and the rising adoption of adhesive resin cement within dentistry.

While resin cement has been employed to enhance the survival of FSMs, it is crucial to note that research investigating periodontal inflammation in children arising from residual cement following the FSM cementation process is lacking. Numerous inflammatory cytokine biomarkers indicate the presence of gingival inflammation. Pro-inflammatory cytokines, tumor necrosis factor(TNF-α), anti-inflammatory cytokines, and host factor metalloproteinases play significant roles in regulating inflammatory responses. Interleukin-18 (IL-18) is a significant pro-inflammatory cytokine belonging to the Interleukin-1 (IL-1) family. It is essential in the immune response to infections and various diseases. The function of IL-18 in the inflammatory response is to facilitate the expression of adhesion molecules on endothelial cells, thereby increasing the recruitment of immune cells to the site of inflammation. The accumulation of IL-18 in regions that are persistently exposed to irritants triggers chronic tissue damage, facilitating the progression of the disease's pathogenesis. The role of IL-18 in immune regulation and inflammation suggests that it may serve as a potential biomarker for tracking the progression of various diseases. Studies have indicated that the expression levels of IL-18 are significantly elevated in gingival crevicular fluid and gingival tissue samples associated with gingival inflammation and periodontal diseases.

Gingival crevicular fluid (GCF) is recognized as the primary medium for analyzing alterations in the local tissue environment, thereby facilitating the assessment of periodontal health and disease. This fluid is instrumental in understanding the physiological changes occurring in periodontal conditions. The noninvasive collection of biomarkers in GCF is an essential diagnostic method for accurately assessing gingival health in clinical settings.

Upon re-evaluating the FSM treatment protocol in light of this information, it becomes clear that FSMs are frequently cemented within the gingival pocket in cases where they come into contact with the gingiva. Current literature remains unclear about inflammation effects in the periodontal sulcus caused by the use of resin cement for luting space maintainers. The null hypothesis of this study posits that FSMs luted with conventional GIC and those luted with resin cement result in identical alterations in IL-18 levels within the GCF of pediatric patients.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Afyonkarahisar, Turkey, 03300
        • Afyonkarahisar Health Sciences University
      • Afyonkarahisar, Turkey, 03300
        • Afyonkarahisar Health Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Voco Meron Conventional Glass Ionomer Group
The right molars were bonded with conventional glass ionomer cement.
Procedure: Voco Meron Conventional Glass Ionomer
The right molars were bonded with Meron
Experimental: High-Q-Bond Band™ self-adhesive resin cement
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.
The left mandibular first molars were bonded with FSM High-Q-Bond Band™ self-adhesive resin cement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-18
Time Frame: 1 week.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque İndex
Time Frame: 1 week
The plaque index measures the amount of plaque accumulated in the periodontium area where the assessment is made. The plaque buildup caused by the fixed space maintainer will be assessed.
1 week
Gingival Index
Time Frame: 1 week
The gingival index is one of the evaluation criteria of periodontal health.
1 week
Periodontal Probing Depth
Time Frame: 1 week
It indicates whether the gingivitis has spread to the alveolar bone. The cause of the inflammation caused by the fixed space maintainer will be investigated.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Afyonkarahisar Health Sciences University

Investigators

  • Study Director: Suat Serhan Altıntepe Doğan, Assoc. Prof. (PhD), Afyonkarahisar Health Sciences University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2022

Primary Completion (Actual)

May 22, 2023

Study Completion (Actual)

May 22, 2023

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

January 31, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-KAEK-2/ 2022/7336

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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