Periodontal Biocompatibility of Pediatric Crowns
Comparative Evaluation of Periodontal Biocompatibility of Pediatric Crowns Using Clinical Parameters and GCF Biomarkers
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Rize, Turkiet (Türkiye)
- Sema Aydinoglu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Group 1
Teeth diagnosed with an indication for full coronal restoration and treated with stainless steel crown.
|
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). |
|
Group 2
Teeth diagnosed with an indication for full coronal restoration and treated with prefabricated zirconia crown.
|
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). |
|
Group 3
Teeth diagnosed with an indication for full coronal restoration and treated with fiber glass crown.
|
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). |
|
Group 4
Healthy primary molars (control group)
|
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). |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
assessment of probing pocket depth (PPD)
Tidsram: 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.
|
From beginning to the end of treatment at 6 months
|
|
assessment of matrix metalloproteinase-8 (MMP-8) level in gingival crevicular fluid (GCF)
Tidsram: 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).
|
in the sixth month (after sample collection was complete)
|
|
Assessment of bleeding on probing (BOP)
Tidsram: 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.
|
From beginning to the end of treatment at 6 months
|
|
Assessment of plaque index (PI)
Tidsram: 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.
|
From beginning to the end of treatment at 6 months
|
|
Assessment of Gingival index (GI)
Tidsram: 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.
|
From beginning to the end of treatment at 6 months
|
|
Assessment of interleukin-1 beta (IL-1β) level in gingival crevicular fluid (GCF)
Tidsram: 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).
|
in the sixth month (after sample collection was complete)
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2024/05 (Annan identifierare: Atatürk University Clinical Research Ethics Committee)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .