Silver Nanoparticle-Coated Orthodontic Brackets for Preventing Enamel Demineralization (AgBracket)
Evaluating the Effectiveness of Silver Nanoparticle-Coated Stainless Steel Brackets in Preventing Enamel Demineralization in Patients Undergoing Fixed Orthodontic Treatment: A Randomised Split-Mouth Clinical Trial
The goal of this clinical trial is to learn whether orthodontic brackets coated with silver nanoparticles can help prevent early damage to tooth enamel in people receiving fixed braces.
The main question it aims to answer is:
-Do silver nanoparticle-coated brackets help reduce enamel demineralization (the early stage of tooth decay) compared with standard stainless steel brackets?
Researchers will compare silver nanoparticle-coated brackets with standard stainless steel brackets. Each participant will receive both types of brackets on different teeth so that the results can be compared within the same person.
Participants will:
- Receive fixed orthodontic treatment as planned.
- Have both silver nanoparticle-coated and standard stainless steel brackets placed on different teeth.
- Attend routine orthodontic appointments.
- Have premolar teeth that were already planned for extraction as part of their orthodontic treatment removed after one month so researchers can examine the tooth enamel around the brackets.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Enamel demineralization is a common complication of fixed orthodontic treatment because dental plaque can accumulate around orthodontic brackets. Silver nanoparticles have demonstrated antimicrobial properties and may help reduce bacterial growth around brackets, potentially decreasing the risk of enamel demineralization.
This randomized split-mouth clinical trial aims to evaluate the effectiveness of silver nanoparticle-coated stainless steel orthodontic brackets in preventing enamel demineralization compared with conventional stainless steel brackets in participants undergoing fixed orthodontic treatment requiring premolar extractions.
Participants will receive both silver nanoparticle-coated and conventional brackets on contralateral premolars according to a randomized allocation. The split-mouth design allows each participant to serve as their own control, reducing the influence of individual differences in oral hygiene, diet, and saliva composition.
After one month of orthodontic treatment, premolars that were already planned for extraction as part of the participants' orthodontic treatment will be removed. Enamel adjacent to the brackets will be evaluated using scanning electron microscopy (SEM) and energy-dispersive X-ray spectroscopy (EDS) to assess surface characteristics and mineral content. The findings will be used to compare the effectiveness of silver nanoparticle-coated and conventional brackets in reducing enamel demineralization during fixed orthodontic treatment.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Ajman, Vereinigte Arabische Emirate
- Ajman University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Patients scheduled for fixed orthodontic treatment requiring premolar extraction
- No history of previous orthodontic treatment done
- Intact enamel surface of the premolars to be extracted
Exclusion Criteria:
- Non-extraction cases
- Patients with previously done orthodontic treatment
- Enamel surface defects on the premolars to be extracted(caries, hypoplasia, cracks etc.)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Silver Nanoparticle-Coated Brackets on Randomized Side
Participants received silver nanoparticle-coated stainless steel orthodontic brackets on one randomly assigned side of the mouth and conventional stainless steel orthodontic brackets on the contralateral side during fixed orthodontic treatment.
The intervention remained in place for one month before the planned extraction of the premolars for enamel evaluation.
|
Stainless steel orthodontic brackets coated with silver nanoparticles were bonded to randomly assigned premolars during fixed orthodontic treatment and remained in place for one month before the planned extraction of the premolars for enamel evaluation.
|
|
Aktiver Komparator: Conventional Brackets on Randomized Side
Participants received conventional stainless steel orthodontic brackets on one randomly assigned side of the mouth and silver nanoparticle-coated stainless steel orthodontic brackets on the contralateral side during fixed orthodontic treatment.
The intervention remained in place for one month before the planned extraction of the premolars for enamel evaluation.
|
Conventional stainless steel orthodontic brackets were bonded to the contralateral premolars during fixed orthodontic treatment and remained in place for one month before the planned extraction of the premolars for enamel evaluation.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Calcium-to-Phosphorus Ratio of Enamel Adjacent to Orthodontic Brackets
Zeitfenster: One month after bracket placement
|
The calcium-to-phosphorus (Ca/P) ratio of enamel adjacent to silver nanoparticle-coated and conventional stainless steel orthodontic brackets will be measured using energy-dispersive X-ray spectroscopy (EDS).
The mean Ca/P ratio will be compared between the two bracket types.
|
One month after bracket placement
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Enamel Surface Morphological Characteristics Adjacent to Orthodontic Brackets
Zeitfenster: One month after bracket placement
|
Enamel surface morphology adjacent to silver nanoparticle-coated and conventional stainless steel orthodontic brackets will be evaluated using scanning electron microscopy (SEM).
Representative SEM images will be analyzed descriptively to assess differences in enamel surface appearance between the two bracket types.
|
One month after bracket placement
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Jeny M George, MDS, Ajman University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- D-F-H-24-11-18-b
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur White-Spot-Läsionen
-
Mansoura UniversityAktiv, nicht rekrutierend
-
Sigmund Freud PrivatUniversitatNoch keine RekrutierungWhite-Spot-Läsionen
-
Future University in EgyptNoch keine RekrutierungWhite-Spot-Läsion
-
Ain Shams UniversityAnmeldung auf Einladung
-
Cairo UniversityNoch keine RekrutierungWhite-Spot-Läsion des Zahns
-
Jordan University of Science and TechnologyAktiv, nicht rekrutierend
-
University of BaghdadNoch keine RekrutierungWhite-Spot-Läsionen | Schmelz-DemineralisationIrak
-
Mansoura UniversityAktiv, nicht rekrutierendWhite-Spot-Läsionen | Klares Aligner -GerätÄgypten
-
Cairo UniversityNoch keine Rekrutierung
-
Marmara UniversityNoch keine RekrutierungWhite-Spot-Läsion