Oral HealthNCT07611292
Periodontal Biocompatibility of Pediatric Crowns
An observational study of Oral Health and Pediatric Dentistry, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Different full-coverage crown materials are widely used in pediatric dentistry for the restoration of primary teeth with extensive substance loss. Since these restorations remain in close contact with gingival tissues for prolonged periods, they may influence periodontal health depending on their surface… Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health, Pediatric Dentistry, Stainless-steel Crown
- What is being tested?
- Clinical periodontal assessments, GCF measurements and sample collection
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2024to 20 Apr 2026
- How long will I take part?
- 2 Months
- Phase
- Observational
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children who applied for the dental treatment to the Faculty of Dentistry in Rize
Who may be able to join
- Children who were aged between 6 and 9 years
- Children had a score of 3 or 4 on the Frankl Behavioral Scale
- Children had an indication for full coronal restoration in the primary second molars in all the three quadrants
- Presence of extensive or chronic carious lesions involving the pulp with radiographic scores ranging between 2 and 3
- Presence of localized hypoplastic defects
- Normal or non-resorbed interproximal bone levels, defined radiographically as a distance of no more than 2 mm between the interdental bone crest and the cementoenamel junction
- Those where the root resorption level was blunt or the apex was rounded, and those where 1/4 of the root has been resorbed
Who cannot join
- Children had any systemic disease
- History of allergy to local anesthetic agents, nickel, or resin-based restorative materials
- Extremely poor oral hygiene
- Periodontal disease
- Malocclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Periodontal Biocompatibility of Pediatric Crowns Using Clinical Parameters and GCF Biomarkers
Different full-coverage crown materials are widely used in pediatric dentistry for the restoration of primary teeth with extensive substance loss. Since these restorations remain in close contact with gingival tissues for prolonged periods, they may influence periodontal health depending on their surface characteristics, marginal adaptation, and biological properties. The aim of this study was to evaluate the effects of stainless steel crowns (SSC), prefabricated zirconia crowns (PZC), and fiber-glass crowns (FGC) on periodontal health in children using both clinical periodontal parameters and gingival crevicular fluid (GCF) biomarkers, including IL-1β and MMP-8, within a split-mouth study design.
- Conditions
- Oral Health, Pediatric Dentistry, Stainless-steel Crown, Matrix Metalloproteinase, Periodontal Health
- Being tested
- Clinical periodontal assessments, GCF measurements and sample collection
- Keywords
- oral health, pediatric dentistry, periodontal health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical periodontal assessments, GCF measurements and sample collectionOther
Clinical periodontal assessments were carried out for all participants at baseline (T0), as well as during the third-month (T1) and sixth-month (T2) follow-up visits. The clinical periodontal status was assessed with the probing pocket depth (PPD), bleeding on probing (BOP), plaque index (PI), and gingival index (GI).
For each patient, GCF measurements and sample collection were performed at baseline (T0), as well as during the third-month (T1) and sixth-month (T2) visits. MMP-8 and IL-1β analyses were performed on GCF samples by the enzyme-linked immunosorbent assay (ELISA).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Teeth diagnosed with an indication for full coronal restoration and treated with stainless steel crown. Receives: Other: Clinical periodontal assessments, GCF measurements and sample collection | |
| Group 2 | Teeth diagnosed with an indication for full coronal restoration and treated with prefabricated zirconia crown. Receives: Other: Clinical periodontal assessments, GCF measurements and sample collection | |
| Group 3 | Teeth diagnosed with an indication for full coronal restoration and treated with fiber glass crown. Receives: Other: Clinical periodontal assessments, GCF measurements and sample collection | |
| Group 4 | Healthy primary molars (control group) Receives: Other: Clinical periodontal assessments, GCF measurements and sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of probing pocket depth (PPD)
probing pocket depth (PPD) was measured the distance between the gingival margin and the deepest point of the sulcus. PPD was evaluated from six surfaces (mesiobuccal, midbuccal, distobuccal, mesiolingual/mesiopalatal, midlingual/midpalatal, and distolingual/distopalatal) of the teeth. The measurements were done utilizing a Williams periodontal probe.
Measured: From beginning to the end of treatment at 6 months
assessment of matrix metalloproteinase-8 (MMP-8) level in gingival crevicular fluid (GCF)
MMP-8 was performed on GCF samples by the enzyme-linked immunosorbent assay (ELISA) in the Medical Biochemistry Research and Application Laboratory of the Recep Tayyip Erdogan University Faculty of Medicine. Twenty-four hours before the assay procedure, the eppendorf tubes were removed from the deep freezer and allowed to thaw progressively at -20 °C followed by +4 °C. Prior to analysis, both the samples and assay reagents were equilibrated to room temperature (18-25 °C). Each GCF specimen was analyzed individually without combining the samples. The results were expressed in ng/mL (MMP-8).
Measured: in the sixth month (after sample collection was complete)
Assessment of bleeding on probing (BOP)
Bleeding on probing (BOP) scores were obtained from four surfaces (mesial, distal, buccal, and palatal/lingual) of the primary second molars. The measurements were done utilizing a Williams periodontal probe.
Measured: From beginning to the end of treatment at 6 months
Assessment of plaque index (PI)
Plaque index (PI) scores were obtained from four surfaces (mesial, distal, buccal, and palatal/lingual) of the primary second molars. The measurements were done utilizing a Williams periodontal probe.
Measured: From beginning to the end of treatment at 6 months
Assessment of Gingival index (GI)
Gingival index (GI) scores were obtained from four surfaces (mesial, distal, buccal, and palatal/lingual) of the primary second molars. The measurements were done utilizing a Williams periodontal probe.
Measured: From beginning to the end of treatment at 6 months
Assessment of interleukin-1 beta (IL-1β) level in gingival crevicular fluid (GCF)
In GCF samples taken from patients, IL-1β level was determined by enzyme-linked immunosorbent assay (ELISA) according to the manufacturer's instructions at the Medical Biochemistry Research and Application Laboratory of Recep Tayyip Erdoğan University Faculty of Medicine. Twenty-four hours before the assay procedure, the eppendorf tubes were removed from the deep freezer and allowed to thaw progressively at -20 °C followed by +4 °C. Prior to analysis, both the samples and assay reagents were equilibrated to room temperature (18-25 °C). Each GCF specimen was analyzed individually without combining the samples. The results were expressed in pg/mL (IL-1β).
Measured: in the sixth month (after sample collection was complete)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start30 Jun 2024
- Primary completion30 Dec 2025
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral HealthStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sema Aydınoglu, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611292
- Sponsor's protocol ID
- 2024/05
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aydinoglu S, Sakin Ulubay S, Yemenoglu H, Atak M, Kose O. Comparative evaluation of periodontal biocompatibility of pediatric crowns using clinical parameters and GCF biomarkers. BMC Oral Health. 2026 Aug 1;26(1):2119. doi: 10.1186/s12903-026-09482-1.
PubMed 42947093
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Periodontal Biocompatibility of Pediatric Crowns Using Clinical Parameters and GCF Biomarkers
- ClinicalTrials.gov ID
- NCT07611292
- Acronym / sponsor ID
- 2024/05
- Conditions
- Oral Health, Pediatric Dentistry, Stainless-steel Crown, Matrix Metalloproteinase, Periodontal Health
- Keywords
- oral health, pediatric dentistry, periodontal health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 28 May 2026 (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.
Different full-coverage crown materials are widely used in pediatric dentistry for the restoration of primary teeth with extensive substance loss. Since these restorations remain in close contact with gingival tissues for prolonged periods, they may influence periodontal health depending on their surface characteristics, marginal adaptation, and biological properties. The aim of this study was to evaluate the effects of stainless steel crowns (SSC), prefabricated zirconia crowns (PZC), and fiber-glass crowns (FGC) on periodontal health in children using both clinical periodontal parameters and gingival crevicular fluid (GCF) biomarkers, including IL-1β and MMP-8, within a split-mouth study design.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Clinical periodontal assessments, GCF measurements and sample collectionTeeth diagnosed with an indication for full coronal restoration and treated with stainless steel crown. |
| Group 2 | – | Other: Clinical periodontal assessments, GCF measurements and sample collectionTeeth diagnosed with an indication for full coronal restoration and treated with prefabricated zirconia crown. |
| Group 3 | – | Other: Clinical periodontal assessments, GCF measurements and sample collectionTeeth diagnosed with an indication for full coronal restoration and treated with fiber glass crown. |
| Group 4 | – | Other: Clinical periodontal assessments, GCF measurements and sample collectionHealthy primary molars (control group) |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children who applied for the dental treatment to the Faculty of Dentistry in Rize
Key inclusion criteria (7 listed)
- Children who were aged between 6 and 9 years
- Children had a score of 3 or 4 on the Frankl Behavioral Scale
- Children had an indication for full coronal restoration in the primary second molars in all the three quadrants
- Presence of extensive or chronic carious lesions involving the pulp with radiographic scores ranging between 2 and 3
- Presence of localized hypoplastic defects
Key exclusion criteria (5 listed)
- Children had any systemic disease
- History of allergy to local anesthetic agents, nickel, or resin-based restorative materials
- Extremely poor oral hygiene
- Periodontal disease
- Malocclusion
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 |
|---|---|---|
| Clinical periodontal assessments, GCF measurements and sample collectionClinical periodontal assessments were carried out for all participants at baseline (T0), as well as during the third-month (T1) and sixth-month (T2) follow-up visits. The clinical periodontal status was assessed with the probing pocket depth (PPD), bleeding on probing (BOP), plaque index (PI), and gingival index (GI). For each patient, GCF measurements and sample collection were performed at baseline (T0), as well as during the third-month (T1) and sixth-month (T2) visits. MMP-8 and IL-1β analyses were performed on GCF samples by the enzyme-linked immunosorbent assay (ELISA). | Other | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
assessment of probing pocket depth (PPD)
Time frame: From beginning to the end of treatment at 6 months
probing pocket depth (PPD) was measured the distance between the gingival margin and the deepest point of the sulcus. PPD was evaluated from six surfaces (mesiobuccal, midbuccal, distobuccal, mesiolingual/mesiopalatal, midlingual/midpalatal, and distolingual/distopalatal) of the teeth. The measurements were done utilizing a Williams periodontal probe.
assessment of matrix metalloproteinase-8 (MMP-8) level in gingival crevicular fluid (GCF)
Time frame: in the sixth month (after sample collection was complete)
MMP-8 was performed on GCF samples by the enzyme-linked immunosorbent assay (ELISA) in the Medical Biochemistry Research and Application Laboratory of the Recep Tayyip Erdogan University Faculty of Medicine. Twenty-four hours before the assay procedure, the eppendorf tubes were removed from the deep freezer and allowed to thaw progressively at -20 °C followed by +4 °C. Prior to analysis, both the samples and assay reagents were equilibrated to room temperature (18-25 °C). Each GCF specimen was analyzed individually without combining the samples. The results were expressed in ng/mL (MMP-8).
Assessment of bleeding on probing (BOP)
Time frame: From beginning to the end of treatment at 6 months
Bleeding on probing (BOP) scores were obtained from four surfaces (mesial, distal, buccal, and palatal/lingual) of the primary second molars. The measurements were done utilizing a Williams periodontal probe.
Assessment of plaque index (PI)
Time frame: From beginning to the end of treatment at 6 months
Plaque index (PI) scores were obtained from four surfaces (mesial, distal, buccal, and palatal/lingual) of the primary second molars. The measurements were done utilizing a Williams periodontal probe.
Assessment of Gingival index (GI)
Time frame: From beginning to the end of treatment at 6 months
Gingival index (GI) scores were obtained from four surfaces (mesial, distal, buccal, and palatal/lingual) of the primary second molars. The measurements were done utilizing a Williams periodontal probe.
Assessment of interleukin-1 beta (IL-1β) level in gingival crevicular fluid (GCF)
Time frame: in the sixth month (after sample collection was complete)
In GCF samples taken from patients, IL-1β level was determined by enzyme-linked immunosorbent assay (ELISA) according to the manufacturer's instructions at the Medical Biochemistry Research and Application Laboratory of Recep Tayyip Erdoğan University Faculty of Medicine. Twenty-four hours before the assay procedure, the eppendorf tubes were removed from the deep freezer and allowed to thaw progressively at -20 °C followed by +4 °C. Prior to analysis, both the samples and assay reagents were equilibrated to room temperature (18-25 °C). Each GCF specimen was analyzed individually without combining the samples. The results were expressed in pg/mL (IL-1β).
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 28 May 2026.
- Derived from this study: PubMed 42947093Aydinoglu S, Sakin Ulubay S, Yemenoglu H, Atak M, Kose O. Comparative evaluation of periodontal biocompatibility of pediatric crowns using clinical parameters and GCF biomarkers. BMC Oral Health. 2026 Aug 1;26(1):2119. doi: 10.1186/s12903-026-09482-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Health and Pediatric Dentistry, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site 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 7 inclusion and 5 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 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
assessment of probing pocket depth (PPD) (time frame: From beginning to the end of treatment at 6 months). The study lists 6 primary outcomes in all. 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 NCT07611292, which also lists 1 linked publication.
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 28 May 2026.