Gingival and Periodontal DiseasePhase 4NCT06811597
The Effects of Fixed Space Maintainers Luting with Self-Adhesive Resin Cement on the Gingival Crevicular Fluid of Interleukin-18 Level
A Phase 4 study testing Voco Meron Conventional Glass Ionomer and High-Q-Bond Band™ self-adhesive resin cement. in people with Gingival and Periodontal Disease and Space Maintenance, run by Afyonkarahisar Health Sciences University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Gingival and Periodontal Disease, Space Maintenance, Resin Cements
- What is being tested?
- Voco Meron Conventional Glass Ionomer and High-Q-Bond Band™ self-adhesive resin cement.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 13 Jun 2022to 22 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Afyonkarahisar Health Sciences University
Afyonkarahisar, 03300
Afyonkarahisar Health Science
Afyonkarahisar, 03300
About this study
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.
Read the 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.
- Being tested
- Voco Meron Conventional Glass Ionomer, High-Q-Bond Band™ self-adhesive resin cement.
- Keywords
- Fixed Space Maintainer, IL-18, Resin Cement, Self Adhesive, Gingival Inflammation, Luting Cement
- Medical subject headings
- Periodontal Diseases, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voco Meron Conventional Glass IonomerProcedure or surgery
The right molars were bonded with Meron
High-Q-Bond Band™ self-adhesive resin cement.Procedure or surgery
The left mandibular first molars were bonded with FSM High-Q-Bond Band™ self-adhesive resin cement.
| Study group | Role | What they receive |
|---|---|---|
| Voco Meron Conventional Glass Ionomer Group | Active comparator | The right molars were bonded with conventional glass ionomer cement. Receives: 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. Receives: Procedure: High-Q-Bond Band™ self-adhesive resin cement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week.
Secondary outcomes (3)
Plaque İndex
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.
Measured: 1 week
Gingival Index
The gingival index is one of the evaluation criteria of periodontal health.
Measured: 1 week
Periodontal Probing Depth
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start13 Jun 2022
- Primary completion22 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Gingival and Periodontal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgür Doğan, Afyonkarahisar Health Sciences University
- Investigators
- Suat Serhan Altıntepe Doğan, Assoc. Prof. (PhD), Study director, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811597
- Sponsor's protocol ID
- 2011-KAEK-2/ 2022/7336
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cengiz A, Karayilmaz H. Comparative evaluation of the clinical success of 3D-printed space maintainers and band-loop space maintainers. Int J Paediatr Dent. 2024 Sep;34(5):584-592. doi: 10.1111/ipd.13159. Epub 2024 Jan 12.
PubMed 38217333Dinarello CA. Interleukin 1 and interleukin 18 as mediators of inflammation and the aging process. Am J Clin Nutr. 2006 Feb;83(2):447S-455S. doi: 10.1093/ajcn/83.2.447S.
PubMed 16470011Johnson RB, Serio FG. Interleukin-18 concentrations and the pathogenesis of periodontal disease. J Periodontol. 2005 May;76(5):785-90. doi: 10.1902/jop.2005.76.5.785.
PubMed 15898940Jablonska E, Izycka A, Jablonska J, Wawrusiewicz N, Piecuch J. Role of IL-18 in the secretion of Il-1beta, sIL-1RII, and IL-1Ra by human neutrophils. Immunol Invest. 2001 Aug;30(3):221-9. doi: 10.1081/imm-100105066.
PubMed 11570642Orozco A, Gemmell E, Bickel M, Seymour GJ. Interleukin-1beta, interleukin-12 and interleukin-18 levels in gingival fluid and serum of patients with gingivitis and periodontitis. Oral Microbiol Immunol. 2006 Aug;21(4):256-60. doi: 10.1111/j.1399-302X.2006.00292.x.
PubMed 16842511Nair V, Grover V, Arora S, Das G, Ahmad I, Ohri A, Sainudeen S, Saluja P, Saha A. Comparative Evaluation of Gingival Crevicular Fluid Interleukin-17, 18 and 21 in Different Stages of Periodontal Health and Disease. Medicina (Kaunas). 2022 Aug 3;58(8):1042. doi: 10.3390/medicina58081042.
PubMed 36013509Kinney JS, Morelli T, Oh M, Braun TM, Ramseier CA, Sugai JV, Giannobile WV. Crevicular fluid biomarkers and periodontal disease progression. J Clin Periodontol. 2014 Feb;41(2):113-120. doi: 10.1111/jcpe.12194. Epub 2013 Dec 12.
PubMed 24303954Kaur J, Singh A, Sadana G, Mehra M, Mahajan M. Evaluation of Shear Peel Bond Strength of Different Adhesive Cements Used for Fixed Space Maintainer Cementation: An In Vitro Study. Int J Clin Pediatr Dent. 2021 Mar-Apr;14(2):175-179. doi: 10.5005/jp-journals-10005-1932.
PubMed 34413586Ierardo G, Luzzi V, Lesti M, Vozza I, Brugnoletti O, Polimeni A, Bossu M. Peek polymer in orthodontics: A pilot study on children. J Clin Exp Dent. 2017 Oct 1;9(10):e1271-e1275. doi: 10.4317/jced.54010. eCollection 2017 Oct.
PubMed 29167720Khanna S, Rao D, Panwar S, Pawar BA, Ameen S. 3D Printed Band and Loop Space Maintainer: A Digital Game Changer in Preventive Orthodontics. J Clin Pediatr Dent. 2021 Jul 1;45(3):147-151. doi: 10.17796/1053-4625-45.3.1.
PubMed 34192758Neto HNM, Leite JVC, de Medeiros JM, E Silva Campos D, de Araujo Ferreira Muniz I, De Andrade AKM, Duarte RM, De Souza GM, Lima RBW. Scoping review: Effect of surface treatments on bond strength of resin composite repair. J Dent. 2024 Jan;140:104737. doi: 10.1016/j.jdent.2023.104737. Epub 2023 Oct 8.
PubMed 37816488Anumula L, Ramesh S, Kolaparthi VSK. Matrix metalloproteinases in dentin: Assessing their presence, activity, and inhibitors - a review of current trends. Dent Mater. 2024 Nov;40(11):2051-2073. doi: 10.1016/j.dental.2024.09.011. Epub 2024 Oct 5.
PubMed 39368893Barathi D, Jampanapalli SR, Patloth T, Konda S, Inguva H, Shaik H. Comparative Evaluation of Shear Bond Strength of Bonded Space Maintainers Using Ormocers, Nanofilled and Glass Fiber-reinforced Adhesive Composites. Int J Clin Pediatr Dent. 2024 Jun;17(6):695-701. doi: 10.5005/jp-journals-10005-2904.
PubMed 39391145Alvarenga M, Machado L, Prado A, Veloso S, Monteiro G. Self-adhesive resin cement versus conventional cements on the failure rate of indirect single-tooth restorations: A systematic review and meta-analysis of randomized clinical trials. J Prosthet Dent. 2024 Nov;132(5):880.e1-880.e8. doi: 10.1016/j.prosdent.2024.04.027. Epub 2024 May 25.
PubMed 38797576Hemdan ME, El Kalla IHH, El Agamy RA. Clinical Evaluation of Different Designs of Fixed Space Maintainer: A Randomized Clinical Trial. Int J Clin Pediatr Dent. 2024 Apr;17(4):442-450. doi: 10.5005/jp-journals-10005-2835.
PubMed 39144172
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Fixed Space Maintainers Luting with Self-Adhesive Resin Cement on the Gingival Crevicular Fluid of Interleukin-18 Level
- ClinicalTrials.gov ID
- NCT06811597
- Acronym / sponsor ID
- 2011-KAEK-2/ 2022/7336
- Keywords
- Fixed Space Maintainer, IL-18, Resin Cement, Self Adhesive, Gingival Inflammation, Luting Cement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Voco Meron Conventional Glass Ionomer Group | Active comparator | Procedure: Voco Meron Conventional Glass IonomerThe right molars were bonded with conventional glass ionomer cement. |
| High-Q-Bond Band™ self-adhesive resin cement | Experimental | 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voco Meron Conventional Glass IonomerThe right molars were bonded with Meron | Procedure or surgery | Voco Meron Conventional Glass Ionomer Group |
| 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 or surgery | High-Q-Bond Band™ self-adhesive resin cement |
Primary outcome
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.
3 secondary outcomes
Plaque İndex
Time frame: 1 week
Gingival Index
Time frame: 1 week
Periodontal Probing Depth
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Background: PubMed 38217333Cengiz A, Karayilmaz H. Comparative evaluation of the clinical success of 3D-printed space maintainers and band-loop space maintainers. Int J Paediatr Dent. 2024 Sep;34(5):584-592. doi: 10.1111/ipd.13159. Epub 2024 Jan 12.
- Background: PubMed 16470011Dinarello CA. Interleukin 1 and interleukin 18 as mediators of inflammation and the aging process. Am J Clin Nutr. 2006 Feb;83(2):447S-455S. doi: 10.1093/ajcn/83.2.447S.
- Background: PubMed 15898940Johnson RB, Serio FG. Interleukin-18 concentrations and the pathogenesis of periodontal disease. J Periodontol. 2005 May;76(5):785-90. doi: 10.1902/jop.2005.76.5.785.
- Background: PubMed 11570642Jablonska E, Izycka A, Jablonska J, Wawrusiewicz N, Piecuch J. Role of IL-18 in the secretion of Il-1beta, sIL-1RII, and IL-1Ra by human neutrophils. Immunol Invest. 2001 Aug;30(3):221-9. doi: 10.1081/imm-100105066.
- Background: PubMed 16842511Orozco A, Gemmell E, Bickel M, Seymour GJ. Interleukin-1beta, interleukin-12 and interleukin-18 levels in gingival fluid and serum of patients with gingivitis and periodontitis. Oral Microbiol Immunol. 2006 Aug;21(4):256-60. doi: 10.1111/j.1399-302X.2006.00292.x.
- Background: PubMed 36013509Nair V, Grover V, Arora S, Das G, Ahmad I, Ohri A, Sainudeen S, Saluja P, Saha A. Comparative Evaluation of Gingival Crevicular Fluid Interleukin-17, 18 and 21 in Different Stages of Periodontal Health and Disease. Medicina (Kaunas). 2022 Aug 3;58(8):1042. doi: 10.3390/medicina58081042.
- Background: PubMed 24303954Kinney JS, Morelli T, Oh M, Braun TM, Ramseier CA, Sugai JV, Giannobile WV. Crevicular fluid biomarkers and periodontal disease progression. J Clin Periodontol. 2014 Feb;41(2):113-120. doi: 10.1111/jcpe.12194. Epub 2013 Dec 12.
- Background: PubMed 34413586Kaur J, Singh A, Sadana G, Mehra M, Mahajan M. Evaluation of Shear Peel Bond Strength of Different Adhesive Cements Used for Fixed Space Maintainer Cementation: An In Vitro Study. Int J Clin Pediatr Dent. 2021 Mar-Apr;14(2):175-179. doi: 10.5005/jp-journals-10005-1932.
- Background: PubMed 29167720Ierardo G, Luzzi V, Lesti M, Vozza I, Brugnoletti O, Polimeni A, Bossu M. Peek polymer in orthodontics: A pilot study on children. J Clin Exp Dent. 2017 Oct 1;9(10):e1271-e1275. doi: 10.4317/jced.54010. eCollection 2017 Oct.
- Background: PubMed 34192758Khanna S, Rao D, Panwar S, Pawar BA, Ameen S. 3D Printed Band and Loop Space Maintainer: A Digital Game Changer in Preventive Orthodontics. J Clin Pediatr Dent. 2021 Jul 1;45(3):147-151. doi: 10.17796/1053-4625-45.3.1.
- Background: PubMed 37816488Neto HNM, Leite JVC, de Medeiros JM, E Silva Campos D, de Araujo Ferreira Muniz I, De Andrade AKM, Duarte RM, De Souza GM, Lima RBW. Scoping review: Effect of surface treatments on bond strength of resin composite repair. J Dent. 2024 Jan;140:104737. doi: 10.1016/j.jdent.2023.104737. Epub 2023 Oct 8.
- Background: PubMed 39368893Anumula L, Ramesh S, Kolaparthi VSK. Matrix metalloproteinases in dentin: Assessing their presence, activity, and inhibitors - a review of current trends. Dent Mater. 2024 Nov;40(11):2051-2073. doi: 10.1016/j.dental.2024.09.011. Epub 2024 Oct 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suat Serhan Altıntepe Doğan, Assoc. Prof. (PhD) study director
Afyonkarahisar Health Sciences University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Voco Meron Conventional Glass Ionomer and High-Q-Bond Band™ self-adhesive resin cement. in people with Gingival and Periodontal Disease and Space Maintenance, run by Afyonkarahisar Health Sciences University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-18 (time frame: 1 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06811597, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.